Analytical Services

IQVIA Ltd requires access to NHS England data for the purpose of providing commercial services to clients in the health sector or clients that support the Health Sector.

IQVIA Ltd is a commercial company which generates profit from providing services and solutions, including analysis, interpretation and reports, to its customers. Those analyses, interpretations and reports assist such customers in supporting the understanding of care pathways, delivering clarity to hospitals on their use of medicines, enabling the development of diagnostic algorithms, enabling patients to be recruited to trials, and supporting healthcare commissioners and providers in achieving exceptional Data quality. These services can enable the development of health economic models that evaluate care delivery in relation to outcomes achieved for the patient and in so doing, help advance and benefit healthcare in a variety of different ways.

IQVIA Ltd will use the data to provide the following commercial services only:

1. Visualise Healthcare Data (VHD)

This is a suite of software tools into which the record level Data is loaded. All Data seen by end users is aggregated, small number suppressed and are compliant with the HES Analysis Guide. The software tool allows users to perform analyses on aggregated data to view metrics using tables, graphs, maps and charts.

VHD gives role-based access to users, both internal and external users, to produce graphical and tabular estimates of burden of disease, cost of care, common comorbidities, and similar analyses. These analyses may be stratified by diagnosis, organisation, and other similar parameters. In addition, it allows users to stratify by disease and therapy counts (patients and events), gender, age grouping, events over time and geographical based counts.

Other VHD software tools offer nuances of these stratifications including event (diagnosis or therapy types) based breakdowns of medical event counts, user definable age ranges, recruitment models over time with user definable variables, and various visualisations to describe treatment patterns or disease progression.

VHD allows users to analyse complex data more easily, in a more responsive and interactive manner than is possible without the tool.

Internal Users who are substantive employees of IQVIA Ltd are responsible for importing the data from NHS England into the VHD suite of software tools and will have access to record level data for that purpose.

Internal Users who are substantive employees of IQVIA Ltd who perform analysis only access to aggregated data with small numbers suppressed in line with the HES Analysis Guide

Any external user will only have access to aggregated data with small numbers suppressed in line with the HES Analysis Guide

Organisations using this tool as a standalone service would be limited to:

• NHS secondary, community and mental health care providers

• Integrated Care Systems

• Primary care providers

• Private secondary care providers

• Commissioning Support Units

• NHS England

• Health and Wellbeing Boards

• Life science industry

• Pharmaceutical companies

• Medical Device companies

• Industry bodies – limited to the Association of the British Pharmaceutical Industry (ABPI), Ethical Medicines Industry Group (EMIG) and the Proprietary Associated of Great Britain (PAGB)

• Government and government-aligned organisations (e.g. DHSC, NICE)

• Patient groups, charities, and not-for-profit organisations

Organisations using this tool as a standalone service would be limited to:

Visualising Healthcare Data is also used as part of the suite of tools used to deliver the services listed in this Data Sharing Agreement, in addition to being a standalone service.

2. Care Pathway Analysis

This service solely provides analysis relating to the patient journey throughout a treatment, identifying variation in treatment, outcomes and costs associated with that treatment. The purpose of this is to assist with understanding the impact of the treatment (or lack of) on the healthcare system for its delivery of the particular treatment and the associated care pathway. Users are presented with simple views of aggregated care pathways.

This service solely provides analysis relating to the patient journey throughout the evolution of a disease or its treatment, identifying variation in treatment, outcomes and costs associated with that disease or treatment. The purpose of this is to assist with understanding the impact of the condition or treatment (or lack of treatment) on the healthcare system. Users are presented with simple views of aggregated care pathways.

Organisations using this service would be limited to:

• NHS secondary, community and mental health care providers

• Integrated Care Systems

• Primary care providers

• Private secondary care providers

• Commissioning Support Units

• NHS England

• Health and Wellbeing Boards

• Life science industry*

• Pharmaceutical companies*

• Medical Device companies*

• Industry bodies – limited to the Association of the British Pharmaceutical Industry (ABPI), Ethical Medicines Industry Group (EMIG) and the Proprietary Associated of Great Britain (PAGB)

• Government and government-aligned organisations (e.g. DHSC, NICE)

• Patient groups, charities, and not-for-profit organisations

*Industry companies and bodies have an interest in understanding the nature of care pathways and care delivery so that they can both understand and assist their client, the NHS. These companies and trade bodies can improve treatments; offer further support, education, and services; support adherence to National NICE guidance and local treatment guidelines and protocols; and assist in alleviating challenges when they are aware of the difficulties in disease identification and care delivery. These are not related to marketing or sales purposes but focused on being able to understand and better equip the NHS to deliver the best care for the patient. For example, IQVIA Ltd had a life science company client engagement with an objective to understand and ensure the appropriate use of innovative NICE approved medicines in the eligible patient population in the renal therapy area.

3. Hospital Optimisation Benchmarking

This service provides benchmarking capabilities enabling select trusts and national comparisons across a range of clinical, financial, and operational measures. This is enhanced with the use of the Summary Hospital Level Mortality Indicator (SHMI ) data to enable SHMI comparisons to be made, in conjunction with related benchmarked measures.

This service is very similar to the Care Pathway Analysis service but the key difference is that the Hospital Optimisation Benchmarking service is self-service requiring a client to have both the time and ability to conduct analysis using the tool themselves.

Care Pathway Analysis is where IQVIA uses the tools to run an analysis on behalf of the client. A client would choose the best option based on which suits their needs and the question that needs to be solved.

IQVIA’s contracts with clients will clearly specify the name of the service provided and this would reflect how the data was accessed and analysed.

For the Hospital Optimisation Benchmarking service, IQVIA Ltd staff use the tool to assess trust data quality, looking specifically at Clinical Coding, providing written reports (Word, Excel, and PowerPoint) detailing how Trusts compare Nationally and with their Peers.

Organisations using this service would be limited to:

• NHS secondary, community and mental health care providers

• Integrated Care Systems

• Private secondary care providers

• Commissioning Support Units

• NHS England

4. Clinical trial site identification

IQVIA Ltd uses the prevalence of diseases within the supplied data to identify possible geographical sites for clinical trials. This can then be shared with clients, recognising and encouraging the scale and value of investing in the United Kingdom for clinical trials, as well as with the Research and Development teams within health organisations to identify areas for potential income opportunities via clinical trial funding.

Organisations using this service would be limited to:

• NHS secondary, community and mental health care providers

• Primary care providers

• Life science industry

• Pharmaceutical companies

• Medical Device companies

5. Evidence Based Interventions (EBI)

This dashboard is being developed to specifically support improvements by assessing if the correct criteria are met before certain procedures are undertaken using clinical coding.

IQVIA Clinical Coding Analytics (CCA) are developing a new EBI module to support our clients to identify, monitor and track performance   The new module will allow clients to track their performance over time and have a range of features to understand how performance compares to select trusts.

The EBI Module is a dashboard development for 2022/23. This will utilise HES data to interrogate in more detail issues relating to:

o Primary care referral sources

o Helping to support advice and guidance engagement with primary care.

o Alleviating avoidable delays in referrals

o Secondary care clinicians

o Supporting audit of approval processes.

o Determining if individual funding request or prior approvals have been submitted.

o Quality indicators such as:

o Hospital acquired conditions

o Post operative complications

o Mortality

o Emergency readmissions

Used alongside IQVIA Ltd’s other Clinical Coding Analytics dashboards, the users will acquire a more rounded and complete view of hospital performance, thereby providing the support required to improve the quality of patient care, whilst achieving financial balance.

As per all modules within the Clinical Coding Analytics suite, the aggregated data will be appropriately supressed and redacted as required.

Individual trusts will only be able to see the aggregated data for their own trust; controls will be implemented to prevent the user from defining a peer group with only 1 other Trust.

Organisations using this service would be limited to:

• Integrated Care Systems

• Commissioning Support Units

• NHS England

The above IQVIA services provide a different view of the data than is possible via other methods by providing a more holistic insight into the patient's impact on the system. NHS England does not provide an equivalent service. The approach can mean going beyond more narrowly defined datasets (including e.g. audits or registries) to understand wider impact. This includes impact of care on patients, and of patients on the healthcare system. It also additionally enables an understanding of the variation in care delivery and an insight into the planning of care delivery (as a response to, or at times driving, this variation).

The following NHS Digital data will be accessed:

• Hospital Episode Statistics Admitted Patient Care, Accident & Emergency, Critical Care and Outpatients - necessary to provide services to undertake analysis, develop services and provide solutions to providers of healthcare and life sciences services.

• Emergency Care Data Set (ECDS) - necessary because this dataset replaced HES Accident & Emergency data

• Civil Registration Mortality – necessary to enable IQVIA Ltd to better understand observed patterns in mortality with the aim of improving outcomes

• Summary Hospital-level Mortality Indicator (SHMI) – necessary because it will better inform NHS Trusts and help with the investigations where mortality is higher than expected

The level of the data will be pseudonymised.

The data will be minimised as follows

• Limited to data between 2020/21 and latest available

• 5 full years of data plus the latest available data can be held within the duration of the Data Sharing Agreement

• On a project-by-project basis, IQVIA Ltd will determine the minimum amount of data necessary is used

IQVIA Ltd is the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests of the data controller or the legitimate interests of a third party, unless there is a good reason to protect the individual’s personal data which overrides those legitimate interests.

IQVIA Ltd, as part of their Legitimate Interests, will use the data to provide commercial services to improve healthcare for citizen’s and provide support services to healthcare providers to enable those providers to deliver better healthcare to citizens.

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The processing of the data is in the public interest as it will aid in the improvement of healthcare for citizen’s and provide support services to healthcare providers to enable those providers to deliver better healthcare to citizens.

IQVIA Ltd charges its clients for the services they provide.

There are no other organisations involved under this Agreement.

IQVIA Ltd hold bi-annual meetings with a Patient Data Advisory Group. In these meeting the following items are discussed:

• What patient data is held by IQVIA Ltd

• What the data is currently being used for

• What benefits of using the data have been achieved since the last meeting

• The controls and security around the data

Patients are consulted on their views of IQVIA Ltd’s use of patient data.

The expected outputs of the processing will be:

• Presentations to clients related to the specific service provided

• A report of findings to clients as required

• The VHD tools can be utilised as a resource for health resource utilisation, planning and development of epidemiology analysis.

• Sharing of insights generated from the activities related to this Data Sharing Agreement to be made available on the IQVIA Ltd Website.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Direct bilateral engagement with clients

• Reporting findings to clients via presentations using Microsoft Office

The following are examples of outputs for each of the types of services:

1. Visualise Healthcare Data (VHD)

Users are given role-based access to the software tools which allow users to produce graphical and tabular estimates of burden of disease, cost of care, common comorbidities and similar analyses. These analyses may be stratified by diagnosis, organisation and other similar parameters.

VHD includes Cohort Builder reporting, which includes stratification by disease and therapy counts (patients and events), gender, age grouping, events over time and geographical based counts (if available).

Other VHD software tools offer nuances of these stratifications including event (diagnosis or therapy types) based breakdowns of medical event counts, user definable age ranges, recruitment models over time with user definable variables, and various visualisations to describe treatment patterns or disease progression using aggregated small number suppressed data only.

Users can only access aggregated data with small numbers suppressed in line with the HES Analysis Guide.

2. Care Pathway Analysis

This service is either deployed directly to users or used to support consulting projects. In the former case, users are given role-based access to a software tool which will allow them to analyse images of aggregated pathways. In the latter case, outputs will be presentations and reports containing pathway images as well as IQVIA recommendations.

Users can only access aggregated data with small numbers suppressed in line with the HES Analysis Guide.

3. Hospital Optimisation Benchmarking

This service provides benchmarking capabilities enabling select trusts and national comparisons across a range of clinical, financial and operational measures. This will be further enhanced with the use of the Summary Hospital Level Mortality data to enable SHMI comparisons to be made, in conjunction with related benchmarked measures. The outputs are written reports (Word, Excel, and PowerPoint) detailing how Trusts compare Nationally and with their select trusts regarding their data quality, looking specifically at Clinical Coding. Outputs contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

4. Clinical trial site identification

The outputs would be in the form of an aggregated table of patient numbers across trust. This allows the identification and prioritisation of sites most likely to have patients most appropriate for a specific clinical trial. Small numbers would be suppressed in line with the HES Analysis Guide.

5. Evidence Based Interventions (EBI)

Outputs are anticipated at the end of 2023 when the basic EBI service will be available. They will be in the form of an interactive dashboard and written reports (Word and PowerPoint). Outputs contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

1. Visualise Healthcare Data

IQVIA Ltd produced data highlighting the demand of patients and impact on the system of patients with aortic stenosis, and subsequently requiring either surgical aortic valve replacement or transcatheter aortic valve replacement. These two procedures have very different patient experiences, patient outcomes, and resource impacts on the hospital (in terms of costs, as well as estates needed and lengths of stay). This work has enabled clinicians and commissioners to understand where they need to focus attention for preventative strategies for aortic stenosis, as well as planning for current and future treatments for patients.

This is particularly relevant in an area like cardiovascular health where there exist a number of disease registries and audits. While these are valuable databases, they have express purposes including activity capture and establishing the clinical quality improvement cycle. VHD was used beyond the narrow focus on the aortic valve replacement procedure (as in registries), to understand the wider impact of aortic stenosis on the patients and the care delivery teams. This had implications for the planning and organisation of facilities to perform these procedures (or their alternatives) and for whom. It additionally enables a deeper exploration of the nature of that care delivery and its change over time, exploring the low usage of this procedure compared to Europe (as per the UK National Audit Transcathetic Aortic Valve Implantation). This has been included in conversations at hospitals, with commissioners, and with NHS England teams looking for success against the NHS Long Term Plan.

Another use of VHD has been in colorectal cancer care. There are changes in the way many cancers are treated, with more intensive and long treatment regimens in classical chemotherapy giving way to more personalised immune-oncological treatments. This requires not just new medical and pharmaceutical technologies but the ability of services to deliver them to ensure patients receive the improved experience and outcomes possible. IQVIA Ltd was able to define the number of patients that could be expected to benefit from the transition to these regimens while also highlighting the benefit to these patients of reduced time sitting in infusion chairs or returning to the trust. IQVIA Ltd also highlighted to the trusts the freed up time and costs in the nursing team, as well as the increased number of patients that could be initiated and maintained on treatment with the time released. This has clear implications for the ability to deliver care to patients as well as the impact of that care on patients. These numbers varied across different hospitals but included normal per patient savings of up to approximately 18 hours of infusion chair time, and with overall impacts to hospitals of up to 1,000 additional patients having available time to initiate cancer-fighting treatment.

2. Care Pathway Analysis

The care pathway of severe asthma was analysed to understand patient flows across the system, variation in non-elective admissions, and access to best-practice therapies. Findings generated were presented to NHS England’s Accelerated Access Collaborative, taken up by the Academic Health Science Network, and used to evidence new models of clinical Multidisciplinary Team delivery based on care variation observed – specifically in regards to timely patient access to the most appropriate treatments.

3. Hospital Optimisation Benchmarking

A user of this service, an NHS Trust, provided the following feedback on the benefits they realised through the service:

“The essential strength of Hospital Optimisation Benchmarking is in being able to benchmark cost data with performance metrics across a huge range of specialties, points of delivery and specific departments at a granular level. This is not “Trust aggregated” data, so that we can look at utilisation in our individual eye theatres and the cost implications of that utilisation against freely chosen peers. This is further improved, and under-pinned, by integrating HES data to provide Board level assurance on the findings.”

4. Clinical Trial Site Identification

As IQVIA Ltd have not received data since December 2021 there are no yielded benefits to report for this service.

5. Evidence Based Interventions (EBI)

Outputs are anticipated at the end of 2023 when the basic EBI service will be available and as such there are no yielded benefits to report for this service.

IQVIA Ltd requires access to NHS England data for the purpose of providing commercial services to clients in the health sector or clients that support the Health Sector.

IQVIA Ltd is a commercial company which generates profit from providing services and solutions, including analysis, interpretation and reports, to its customers. Those analyses, interpretations and reports assist such customers in supporting the understanding of care pathways, delivering clarity to hospitals on their use of medicines, enabling the development of diagnostic algorithms, enabling patients to be recruited to trials, and supporting healthcare commissioners and providers in achieving exceptional Data quality. These services can enable the development of health economic models that evaluate care delivery in relation to outcomes achieved for the patient and in so doing, help advance and benefit healthcare in a variety of different ways.

IQVIA Ltd will use the data to provide the following commercial services only:

1. Visualise Healthcare Data (VHD)

This is a suite of software tools into which the record level Data is loaded. All Data seen by end users is aggregated, small number suppressed and are compliant with the HES Analysis Guide. The software tool allows users to perform analyses on aggregated data to view metrics using tables, graphs, maps and charts.

VHD gives role-based access to users, both internal and external users, to produce graphical and tabular estimates of burden of disease, cost of care, common comorbidities, and similar analyses. These analyses may be stratified by diagnosis, organisation, and other similar parameters. In addition, it allows users to stratify by disease and therapy counts (patients and events), gender, age grouping, events over time and geographical based counts.

Other VHD software tools offer nuances of these stratifications including event (diagnosis or therapy types) based breakdowns of medical event counts, user definable age ranges, recruitment models over time with user definable variables, and various visualisations to describe treatment patterns or disease progression.

VHD allows users to analyse complex data more easily, in a more responsive and interactive manner than is possible without the tool.

Internal Users who are substantive employees of IQVIA Ltd are responsible for importing the data from NHS England into the VHD suite of software tools and will have access to record level data for that purpose.

Internal Users who are substantive employees of IQVIA Ltd who perform analysis only access to aggregated data with small numbers suppressed in line with the HES Analysis Guide

Any external user will only have access to aggregated data with small numbers suppressed in line with the HES Analysis Guide

Organisations using this tool as a standalone service would be limited to:

• NHS secondary, community and mental health care providers

• Integrated Care Systems

• Primary care providers

• Private secondary care providers

• Commissioning Support Units

• NHS England

• Health and Wellbeing Boards

• Life science industry

• Pharmaceutical companies

• Medical Device companies

• Industry bodies – limited to the Association of the British Pharmaceutical Industry (ABPI), Ethical Medicines Industry Group (EMIG) and the Proprietary Associated of Great Britain (PAGB)

• Government and government-aligned organisations (e.g. DHSC, NICE)

• Patient groups, charities, and not-for-profit organisations

Organisations using this tool as a standalone service would be limited to:

Visualising Healthcare Data is also used as part of the suite of tools used to deliver the services listed in this Data Sharing Agreement, in addition to being a standalone service.

2. Care Pathway Analysis

This service solely provides analysis relating to the patient journey throughout a treatment, identifying variation in treatment, outcomes and costs associated with that treatment. The purpose of this is to assist with understanding the impact of the treatment (or lack of) on the healthcare system for its delivery of the particular treatment and the associated care pathway. Users are presented with simple views of aggregated care pathways.

This service solely provides analysis relating to the patient journey throughout the evolution of a disease or its treatment, identifying variation in treatment, outcomes and costs associated with that disease or treatment. The purpose of this is to assist with understanding the impact of the condition or treatment (or lack of treatment) on the healthcare system. Users are presented with simple views of aggregated care pathways.

Organisations using this service would be limited to:

• NHS secondary, community and mental health care providers

• Integrated Care Systems

• Primary care providers

• Private secondary care providers

• Commissioning Support Units

• NHS England

• Health and Wellbeing Boards

• Life science industry*

• Pharmaceutical companies*

• Medical Device companies*

• Industry bodies – limited to the Association of the British Pharmaceutical Industry (ABPI), Ethical Medicines Industry Group (EMIG) and the Proprietary Associated of Great Britain (PAGB)

• Government and government-aligned organisations (e.g. DHSC, NICE)

• Patient groups, charities, and not-for-profit organisations

*Industry companies and bodies have an interest in understanding the nature of care pathways and care delivery so that they can both understand and assist their client, the NHS. These companies and trade bodies can improve treatments; offer further support, education, and services; support adherence to National NICE guidance and local treatment guidelines and protocols; and assist in alleviating challenges when they are aware of the difficulties in disease identification and care delivery. These are not related to marketing or sales purposes but focused on being able to understand and better equip the NHS to deliver the best care for the patient. For example, IQVIA Ltd had a life science company client engagement with an objective to understand and ensure the appropriate use of innovative NICE approved medicines in the eligible patient population in the renal therapy area.

3. Hospital Optimisation Benchmarking

This service provides benchmarking capabilities enabling select trusts and national comparisons across a range of clinical, financial, and operational measures. This is enhanced with the use of the Summary Hospital Level Mortality Indicator (SHMI ) data to enable SHMI comparisons to be made, in conjunction with related benchmarked measures.

This service is very similar to the Care Pathway Analysis service but the key difference is that the Hospital Optimisation Benchmarking service is self-service requiring a client to have both the time and ability to conduct analysis using the tool themselves.

Care Pathway Analysis is where IQVIA uses the tools to run an analysis on behalf of the client. A client would choose the best option based on which suits their needs and the question that needs to be solved.

IQVIA’s contracts with clients will clearly specify the name of the service provided and this would reflect how the data was accessed and analysed.

For the Hospital Optimisation Benchmarking service, IQVIA Ltd staff use the tool to assess trust data quality, looking specifically at Clinical Coding, providing written reports (Word, Excel, and PowerPoint) detailing how Trusts compare Nationally and with their Peers.

Organisations using this service would be limited to:

• NHS secondary, community and mental health care providers

• Integrated Care Systems

• Private secondary care providers

• Commissioning Support Units

• NHS England

4. Clinical trial site identification

IQVIA Ltd uses the prevalence of diseases within the supplied data to identify possible geographical sites for clinical trials. This can then be shared with clients, recognising and encouraging the scale and value of investing in the United Kingdom for clinical trials, as well as with the Research and Development teams within health organisations to identify areas for potential income opportunities via clinical trial funding.

Organisations using this service would be limited to:

• NHS secondary, community and mental health care providers

• Primary care providers

• Life science industry

• Pharmaceutical companies

• Medical Device companies

5. Evidence Based Interventions (EBI)

This dashboard is being developed to specifically support improvements by assessing if the correct criteria are met before certain procedures are undertaken using clinical coding.

IQVIA Clinical Coding Analytics (CCA) are developing a new EBI module to support our clients to identify, monitor and track performance   The new module will allow clients to track their performance over time and have a range of features to understand how performance compares to select trusts.

The EBI Module is a dashboard development for 2022/23. This will utilise HES data to interrogate in more detail issues relating to:

o Primary care referral sources

o Helping to support advice and guidance engagement with primary care.

o Alleviating avoidable delays in referrals

o Secondary care clinicians

o Supporting audit of approval processes.

o Determining if individual funding request or prior approvals have been submitted.

o Quality indicators such as:

o Hospital acquired conditions

o Post operative complications

o Mortality

o Emergency readmissions

Used alongside IQVIA Ltd’s other Clinical Coding Analytics dashboards, the users will acquire a more rounded and complete view of hospital performance, thereby providing the support required to improve the quality of patient care, whilst achieving financial balance.

As per all modules within the Clinical Coding Analytics suite, the aggregated data will be appropriately supressed and redacted as required.

Individual trusts will only be able to see the aggregated data for their own trust; controls will be implemented to prevent the user from defining a peer group with only 1 other Trust.

Organisations using this service would be limited to:

• Integrated Care Systems

• Commissioning Support Units

• NHS England

The above IQVIA services provide a different view of the data than is possible via other methods by providing a more holistic insight into the patient's impact on the system. NHS England does not provide an equivalent service. The approach can mean going beyond more narrowly defined datasets (including e.g. audits or registries) to understand wider impact. This includes impact of care on patients, and of patients on the healthcare system. It also additionally enables an understanding of the variation in care delivery and an insight into the planning of care delivery (as a response to, or at times driving, this variation).

The following NHS Digital data will be accessed:

• Hospital Episode Statistics Admitted Patient Care, Accident & Emergency, Critical Care and Outpatients - necessary to provide services to undertake analysis, develop services and provide solutions to providers of healthcare and life sciences services.

• Emergency Care Data Set (ECDS) - necessary because this dataset replaced HES Accident & Emergency data

• Civil Registration Mortality – necessary to enable IQVIA Ltd to better understand observed patterns in mortality with the aim of improving outcomes

• Summary Hospital-level Mortality Indicator (SHMI) – necessary because it will better inform NHS Trusts and help with the investigations where mortality is higher than expected

The level of the data will be pseudonymised.

The data will be minimised as follows

• Limited to data between 2020/21 and latest available

• 5 full years of data plus the latest available data can be held within the duration of the Data Sharing Agreement

• On a project-by-project basis, IQVIA Ltd will determine the minimum amount of data necessary is used

IQVIA Ltd is the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests of the data controller or the legitimate interests of a third party, unless there is a good reason to protect the individual’s personal data which overrides those legitimate interests.

IQVIA Ltd, as part of their Legitimate Interests, will use the data to provide commercial services to improve healthcare for citizen’s and provide support services to healthcare providers to enable those providers to deliver better healthcare to citizens.

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The processing of the data is in the public interest as it will aid in the improvement of healthcare for citizen’s and provide support services to healthcare providers to enable those providers to deliver better healthcare to citizens.

IQVIA Ltd charges its clients for the services they provide.

There are no other organisations involved under this Agreement.

IQVIA Ltd hold bi-annual meetings with a Patient Data Advisory Group. In these meeting the following items are discussed:

• What patient data is held by IQVIA Ltd

• What the data is currently being used for

• What benefits of using the data have been achieved since the last meeting

• The controls and security around the data

Patients are consulted on their views of IQVIA Ltd’s use of patient data.

The expected outputs of the processing will be:

• Presentations to clients related to the specific service provided

• A report of findings to clients as required

• The VHD tools can be utilised as a resource for health resource utilisation, planning and development of epidemiology analysis.

• Sharing of insights generated from the activities related to this Data Sharing Agreement to be made available on the IQVIA Ltd Website.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Direct bilateral engagement with clients

• Reporting findings to clients via presentations using Microsoft Office

The following are examples of outputs for each of the types of services:

1. Visualise Healthcare Data (VHD)

Users are given role-based access to the software tools which allow users to produce graphical and tabular estimates of burden of disease, cost of care, common comorbidities and similar analyses. These analyses may be stratified by diagnosis, organisation and other similar parameters.

VHD includes Cohort Builder reporting, which includes stratification by disease and therapy counts (patients and events), gender, age grouping, events over time and geographical based counts (if available).

Other VHD software tools offer nuances of these stratifications including event (diagnosis or therapy types) based breakdowns of medical event counts, user definable age ranges, recruitment models over time with user definable variables, and various visualisations to describe treatment patterns or disease progression using aggregated small number suppressed data only.

Users can only access aggregated data with small numbers suppressed in line with the HES Analysis Guide.

2. Care Pathway Analysis

This service is either deployed directly to users or used to support consulting projects. In the former case, users are given role-based access to a software tool which will allow them to analyse images of aggregated pathways. In the latter case, outputs will be presentations and reports containing pathway images as well as IQVIA recommendations.

Users can only access aggregated data with small numbers suppressed in line with the HES Analysis Guide.

3. Hospital Optimisation Benchmarking

This service provides benchmarking capabilities enabling select trusts and national comparisons across a range of clinical, financial and operational measures. This will be further enhanced with the use of the Summary Hospital Level Mortality data to enable SHMI comparisons to be made, in conjunction with related benchmarked measures. The outputs are written reports (Word, Excel, and PowerPoint) detailing how Trusts compare Nationally and with their select trusts regarding their data quality, looking specifically at Clinical Coding. Outputs contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

4. Clinical trial site identification

The outputs would be in the form of an aggregated table of patient numbers across trust. This allows the identification and prioritisation of sites most likely to have patients most appropriate for a specific clinical trial. Small numbers would be suppressed in line with the HES Analysis Guide.

5. Evidence Based Interventions (EBI)

Outputs are anticipated at the end of 2023 when the basic EBI service will be available. They will be in the form of an interactive dashboard and written reports (Word and PowerPoint). Outputs contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

1. Visualise Healthcare Data

IQVIA Ltd produced data highlighting the demand of patients and impact on the system of patients with aortic stenosis, and subsequently requiring either surgical aortic valve replacement or transcatheter aortic valve replacement. These two procedures have very different patient experiences, patient outcomes, and resource impacts on the hospital (in terms of costs, as well as estates needed and lengths of stay). This work has enabled clinicians and commissioners to understand where they need to focus attention for preventative strategies for aortic stenosis, as well as planning for current and future treatments for patients.

This is particularly relevant in an area like cardiovascular health where there exist a number of disease registries and audits. While these are valuable databases, they have express purposes including activity capture and establishing the clinical quality improvement cycle. VHD was used beyond the narrow focus on the aortic valve replacement procedure (as in registries), to understand the wider impact of aortic stenosis on the patients and the care delivery teams. This had implications for the planning and organisation of facilities to perform these procedures (or their alternatives) and for whom. It additionally enables a deeper exploration of the nature of that care delivery and its change over time, exploring the low usage of this procedure compared to Europe (as per the UK National Audit Transcathetic Aortic Valve Implantation). This has been included in conversations at hospitals, with commissioners, and with NHS England teams looking for success against the NHS Long Term Plan.

Another use of VHD has been in colorectal cancer care. There are changes in the way many cancers are treated, with more intensive and long treatment regimens in classical chemotherapy giving way to more personalised immune-oncological treatments. This requires not just new medical and pharmaceutical technologies but the ability of services to deliver them to ensure patients receive the improved experience and outcomes possible. IQVIA Ltd was able to define the number of patients that could be expected to benefit from the transition to these regimens while also highlighting the benefit to these patients of reduced time sitting in infusion chairs or returning to the trust. IQVIA Ltd also highlighted to the trusts the freed up time and costs in the nursing team, as well as the increased number of patients that could be initiated and maintained on treatment with the time released. This has clear implications for the ability to deliver care to patients as well as the impact of that care on patients. These numbers varied across different hospitals but included normal per patient savings of up to approximately 18 hours of infusion chair time, and with overall impacts to hospitals of up to 1,000 additional patients having available time to initiate cancer-fighting treatment.

2. Care Pathway Analysis

The care pathway of severe asthma was analysed to understand patient flows across the system, variation in non-elective admissions, and access to best-practice therapies. Findings generated were presented to NHS England’s Accelerated Access Collaborative, taken up by the Academic Health Science Network, and used to evidence new models of clinical Multidisciplinary Team delivery based on care variation observed – specifically in regards to timely patient access to the most appropriate treatments.

3. Hospital Optimisation Benchmarking

A user of this service, an NHS Trust, provided the following feedback on the benefits they realised through the service:

“The essential strength of Hospital Optimisation Benchmarking is in being able to benchmark cost data with performance metrics across a huge range of specialties, points of delivery and specific departments at a granular level. This is not “Trust aggregated” data, so that we can look at utilisation in our individual eye theatres and the cost implications of that utilisation against freely chosen peers. This is further improved, and under-pinned, by integrating HES data to provide Board level assurance on the findings.”

4. Clinical Trial Site Identification

As IQVIA Ltd have not received data since December 2021 there are no yielded benefits to report for this service.

5. Evidence Based Interventions (EBI)

Outputs are anticipated at the end of 2023 when the basic EBI service will be available and as such there are no yielded benefits to report for this service.

IQVIA Ltd requires access to NHS England data for the purpose of providing commercial services to clients in the health sector or clients that support the Health Sector.

IQVIA Ltd is a commercial company which generates profit from providing services and solutions, including analysis, interpretation and reports, to its customers. Those analyses, interpretations and reports assist such customers in supporting the understanding of care pathways, delivering clarity to hospitals on their use of medicines, enabling the development of diagnostic algorithms, enabling patients to be recruited to trials, and supporting healthcare commissioners and providers in achieving exceptional Data quality. These services can enable the development of health economic models that evaluate care delivery in relation to outcomes achieved for the patient and in so doing, help advance and benefit healthcare in a variety of different ways.

IQVIA Ltd will use the data to provide the following commercial services only:

1. Visualise Healthcare Data (VHD)

This is a suite of software tools into which the record level Data is loaded. All Data seen by end users is aggregated, small number suppressed and are compliant with the HES Analysis Guide. The software tool allows users to perform analyses on aggregated data to view metrics using tables, graphs, maps and charts.

VHD gives role-based access to users, both internal and external users, to produce graphical and tabular estimates of burden of disease, cost of care, common comorbidities, and similar analyses. These analyses may be stratified by diagnosis, organisation, and other similar parameters. In addition, it allows users to stratify by disease and therapy counts (patients and events), gender, age grouping, events over time and geographical based counts.

Other VHD software tools offer nuances of these stratifications including event (diagnosis or therapy types) based breakdowns of medical event counts, user definable age ranges, recruitment models over time with user definable variables, and various visualisations to describe treatment patterns or disease progression.

VHD allows users to analyse complex data more easily, in a more responsive and interactive manner than is possible without the tool.

Internal Users who are substantive employees of IQVIA Ltd are responsible for importing the data from NHS England into the VHD suite of software tools and will have access to record level data for that purpose.

Internal Users who are substantive employees of IQVIA Ltd who perform analysis only access to aggregated data with small numbers suppressed in line with the HES Analysis Guide

Any external user will only have access to aggregated data with small numbers suppressed in line with the HES Analysis Guide

Organisations using this tool as a standalone service would be limited to:

• NHS secondary, community and mental health care providers

• Integrated Care Systems

• Primary care providers

• Private secondary care providers

• Commissioning Support Units

• NHS England

• Health and Wellbeing Boards

• Life science industry

• Pharmaceutical companies

• Medical Device companies

• Industry bodies – limited to the Association of the British Pharmaceutical Industry (ABPI), Ethical Medicines Industry Group (EMIG) and the Proprietary Associated of Great Britain (PAGB)

• Government and government-aligned organisations (e.g. DHSC, NICE)

• Patient groups, charities, and not-for-profit organisations

Organisations using this tool as a standalone service would be limited to:

Visualising Healthcare Data is also used as part of the suite of tools used to deliver the services listed in this Data Sharing Agreement, in addition to being a standalone service.

2. Care Pathway Analysis

This service solely provides analysis relating to the patient journey throughout a treatment, identifying variation in treatment, outcomes and costs associated with that treatment. The purpose of this is to assist with understanding the impact of the treatment (or lack of) on the healthcare system for its delivery of the particular treatment and the associated care pathway. Users are presented with simple views of aggregated care pathways.

This service solely provides analysis relating to the patient journey throughout the evolution of a disease or its treatment, identifying variation in treatment, outcomes and costs associated with that disease or treatment. The purpose of this is to assist with understanding the impact of the condition or treatment (or lack of treatment) on the healthcare system. Users are presented with simple views of aggregated care pathways.

Organisations using this service would be limited to:

• NHS secondary, community and mental health care providers

• Integrated Care Systems

• Primary care providers

• Private secondary care providers

• Commissioning Support Units

• NHS England

• Health and Wellbeing Boards

• Life science industry*

• Pharmaceutical companies*

• Medical Device companies*

• Industry bodies – limited to the Association of the British Pharmaceutical Industry (ABPI), Ethical Medicines Industry Group (EMIG) and the Proprietary Associated of Great Britain (PAGB)

• Government and government-aligned organisations (e.g. DHSC, NICE)

• Patient groups, charities, and not-for-profit organisations

*Industry companies and bodies have an interest in understanding the nature of care pathways and care delivery so that they can both understand and assist their client, the NHS. These companies and trade bodies can improve treatments; offer further support, education, and services; support adherence to National NICE guidance and local treatment guidelines and protocols; and assist in alleviating challenges when they are aware of the difficulties in disease identification and care delivery. These are not related to marketing or sales purposes but focused on being able to understand and better equip the NHS to deliver the best care for the patient. For example, IQVIA Ltd had a life science company client engagement with an objective to understand and ensure the appropriate use of innovative NICE approved medicines in the eligible patient population in the renal therapy area.

3. Hospital Optimisation Benchmarking

This service provides benchmarking capabilities enabling select trusts and national comparisons across a range of clinical, financial, and operational measures. This is enhanced with the use of the Summary Hospital Level Mortality Indicator (SHMI ) data to enable SHMI comparisons to be made, in conjunction with related benchmarked measures.

This service is very similar to the Care Pathway Analysis service but the key difference is that the Hospital Optimisation Benchmarking service is self-service requiring a client to have both the time and ability to conduct analysis using the tool themselves.

Care Pathway Analysis is where IQVIA uses the tools to run an analysis on behalf of the client. A client would choose the best option based on which suits their needs and the question that needs to be solved.

IQVIA’s contracts with clients will clearly specify the name of the service provided and this would reflect how the data was accessed and analysed.

For the Hospital Optimisation Benchmarking service, IQVIA Ltd staff use the tool to assess trust data quality, looking specifically at Clinical Coding, providing written reports (Word, Excel, and PowerPoint) detailing how Trusts compare Nationally and with their Peers.

Organisations using this service would be limited to:

• NHS secondary, community and mental health care providers

• Integrated Care Systems

• Private secondary care providers

• Commissioning Support Units

• NHS England

4. Clinical trial site identification

IQVIA Ltd uses the prevalence of diseases within the supplied data to identify possible geographical sites for clinical trials. This can then be shared with clients, recognising and encouraging the scale and value of investing in the United Kingdom for clinical trials, as well as with the Research and Development teams within health organisations to identify areas for potential income opportunities via clinical trial funding.

Organisations using this service would be limited to:

• NHS secondary, community and mental health care providers

• Primary care providers

• Life science industry

• Pharmaceutical companies

• Medical Device companies

5. Evidence Based Interventions (EBI)

This dashboard is being developed to specifically support improvements by assessing if the correct criteria are met before certain procedures are undertaken using clinical coding.

IQVIA Clinical Coding Analytics (CCA) are developing a new EBI module to support our clients to identify, monitor and track performance   The new module will allow clients to track their performance over time and have a range of features to understand how performance compares to select trusts.

The EBI Module is a dashboard development for 2022/23. This will utilise HES data to interrogate in more detail issues relating to:

o Primary care referral sources

o Helping to support advice and guidance engagement with primary care.

o Alleviating avoidable delays in referrals

o Secondary care clinicians

o Supporting audit of approval processes.

o Determining if individual funding request or prior approvals have been submitted.

o Quality indicators such as:

o Hospital acquired conditions

o Post operative complications

o Mortality

o Emergency readmissions

Used alongside IQVIA Ltd’s other Clinical Coding Analytics dashboards, the users will acquire a more rounded and complete view of hospital performance, thereby providing the support required to improve the quality of patient care, whilst achieving financial balance.

As per all modules within the Clinical Coding Analytics suite, the aggregated data will be appropriately supressed and redacted as required.

Individual trusts will only be able to see the aggregated data for their own trust; controls will be implemented to prevent the user from defining a peer group with only 1 other Trust.

Organisations using this service would be limited to:

• Integrated Care Systems

• Commissioning Support Units

• NHS England

The above IQVIA services provide a different view of the data than is possible via other methods by providing a more holistic insight into the patient's impact on the system. NHS England does not provide an equivalent service. The approach can mean going beyond more narrowly defined datasets (including e.g. audits or registries) to understand wider impact. This includes impact of care on patients, and of patients on the healthcare system. It also additionally enables an understanding of the variation in care delivery and an insight into the planning of care delivery (as a response to, or at times driving, this variation).

The following NHS Digital data will be accessed:

• Hospital Episode Statistics Admitted Patient Care, Accident & Emergency, Critical Care and Outpatients - necessary to provide services to undertake analysis, develop services and provide solutions to providers of healthcare and life sciences services.

• Emergency Care Data Set (ECDS) - necessary because this dataset replaced HES Accident & Emergency data

• Civil Registration Mortality – necessary to enable IQVIA Ltd to better understand observed patterns in mortality with the aim of improving outcomes

• Summary Hospital-level Mortality Indicator (SHMI) – necessary because it will better inform NHS Trusts and help with the investigations where mortality is higher than expected

The level of the data will be pseudonymised.

The data will be minimised as follows

• Limited to data between 2020/21 and latest available

• 5 full years of data plus the latest available data can be held within the duration of the Data Sharing Agreement

• On a project-by-project basis, IQVIA Ltd will determine the minimum amount of data necessary is used

IQVIA Ltd is the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests of the data controller or the legitimate interests of a third party, unless there is a good reason to protect the individual’s personal data which overrides those legitimate interests.

IQVIA Ltd, as part of their Legitimate Interests, will use the data to provide commercial services to improve healthcare for citizen’s and provide support services to healthcare providers to enable those providers to deliver better healthcare to citizens.

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The processing of the data is in the public interest as it will aid in the improvement of healthcare for citizen’s and provide support services to healthcare providers to enable those providers to deliver better healthcare to citizens.

IQVIA Ltd charges its clients for the services they provide.

There are no other organisations involved under this Agreement.

IQVIA Ltd hold bi-annual meetings with a Patient Data Advisory Group. In these meeting the following items are discussed:

• What patient data is held by IQVIA Ltd

• What the data is currently being used for

• What benefits of using the data have been achieved since the last meeting

• The controls and security around the data

Patients are consulted on their views of IQVIA Ltd’s use of patient data.

The expected outputs of the processing will be:

• Presentations to clients related to the specific service provided

• A report of findings to clients as required

• The VHD tools can be utilised as a resource for health resource utilisation, planning and development of epidemiology analysis.

• Sharing of insights generated from the activities related to this Data Sharing Agreement to be made available on the IQVIA Ltd Website.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Direct bilateral engagement with clients

• Reporting findings to clients via presentations using Microsoft Office

The following are examples of outputs for each of the types of services:

1. Visualise Healthcare Data (VHD)

Users are given role-based access to the software tools which allow users to produce graphical and tabular estimates of burden of disease, cost of care, common comorbidities and similar analyses. These analyses may be stratified by diagnosis, organisation and other similar parameters.

VHD includes Cohort Builder reporting, which includes stratification by disease and therapy counts (patients and events), gender, age grouping, events over time and geographical based counts (if available).

Other VHD software tools offer nuances of these stratifications including event (diagnosis or therapy types) based breakdowns of medical event counts, user definable age ranges, recruitment models over time with user definable variables, and various visualisations to describe treatment patterns or disease progression using aggregated small number suppressed data only.

Users can only access aggregated data with small numbers suppressed in line with the HES Analysis Guide.

2. Care Pathway Analysis

This service is either deployed directly to users or used to support consulting projects. In the former case, users are given role-based access to a software tool which will allow them to analyse images of aggregated pathways. In the latter case, outputs will be presentations and reports containing pathway images as well as IQVIA recommendations.

Users can only access aggregated data with small numbers suppressed in line with the HES Analysis Guide.

3. Hospital Optimisation Benchmarking

This service provides benchmarking capabilities enabling select trusts and national comparisons across a range of clinical, financial and operational measures. This will be further enhanced with the use of the Summary Hospital Level Mortality data to enable SHMI comparisons to be made, in conjunction with related benchmarked measures. The outputs are written reports (Word, Excel, and PowerPoint) detailing how Trusts compare Nationally and with their select trusts regarding their data quality, looking specifically at Clinical Coding. Outputs contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

4. Clinical trial site identification

The outputs would be in the form of an aggregated table of patient numbers across trust. This allows the identification and prioritisation of sites most likely to have patients most appropriate for a specific clinical trial. Small numbers would be suppressed in line with the HES Analysis Guide.

5. Evidence Based Interventions (EBI)

Outputs are anticipated at the end of 2023 when the basic EBI service will be available. They will be in the form of an interactive dashboard and written reports (Word and PowerPoint). Outputs contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

1. Visualise Healthcare Data

IQVIA Ltd produced data highlighting the demand of patients and impact on the system of patients with aortic stenosis, and subsequently requiring either surgical aortic valve replacement or transcatheter aortic valve replacement. These two procedures have very different patient experiences, patient outcomes, and resource impacts on the hospital (in terms of costs, as well as estates needed and lengths of stay). This work has enabled clinicians and commissioners to understand where they need to focus attention for preventative strategies for aortic stenosis, as well as planning for current and future treatments for patients.

This is particularly relevant in an area like cardiovascular health where there exist a number of disease registries and audits. While these are valuable databases, they have express purposes including activity capture and establishing the clinical quality improvement cycle. VHD was used beyond the narrow focus on the aortic valve replacement procedure (as in registries), to understand the wider impact of aortic stenosis on the patients and the care delivery teams. This had implications for the planning and organisation of facilities to perform these procedures (or their alternatives) and for whom. It additionally enables a deeper exploration of the nature of that care delivery and its change over time, exploring the low usage of this procedure compared to Europe (as per the UK National Audit Transcathetic Aortic Valve Implantation). This has been included in conversations at hospitals, with commissioners, and with NHS England teams looking for success against the NHS Long Term Plan.

Another use of VHD has been in colorectal cancer care. There are changes in the way many cancers are treated, with more intensive and long treatment regimens in classical chemotherapy giving way to more personalised immune-oncological treatments. This requires not just new medical and pharmaceutical technologies but the ability of services to deliver them to ensure patients receive the improved experience and outcomes possible. IQVIA Ltd was able to define the number of patients that could be expected to benefit from the transition to these regimens while also highlighting the benefit to these patients of reduced time sitting in infusion chairs or returning to the trust. IQVIA Ltd also highlighted to the trusts the freed up time and costs in the nursing team, as well as the increased number of patients that could be initiated and maintained on treatment with the time released. This has clear implications for the ability to deliver care to patients as well as the impact of that care on patients. These numbers varied across different hospitals but included normal per patient savings of up to approximately 18 hours of infusion chair time, and with overall impacts to hospitals of up to 1,000 additional patients having available time to initiate cancer-fighting treatment.

2. Care Pathway Analysis

The care pathway of severe asthma was analysed to understand patient flows across the system, variation in non-elective admissions, and access to best-practice therapies. Findings generated were presented to NHS England’s Accelerated Access Collaborative, taken up by the Academic Health Science Network, and used to evidence new models of clinical Multidisciplinary Team delivery based on care variation observed – specifically in regards to timely patient access to the most appropriate treatments.

3. Hospital Optimisation Benchmarking

A user of this service, an NHS Trust, provided the following feedback on the benefits they realised through the service:

“The essential strength of Hospital Optimisation Benchmarking is in being able to benchmark cost data with performance metrics across a huge range of specialties, points of delivery and specific departments at a granular level. This is not “Trust aggregated” data, so that we can look at utilisation in our individual eye theatres and the cost implications of that utilisation against freely chosen peers. This is further improved, and under-pinned, by integrating HES data to provide Board level assurance on the findings.”

4. Clinical Trial Site Identification

As IQVIA Ltd have not received data since December 2021 there are no yielded benefits to report for this service.

5. Evidence Based Interventions (EBI)

Outputs are anticipated at the end of 2023 when the basic EBI service will be available and as such there are no yielded benefits to report for this service.

Under this agreement IQVIA Ltd. and IQVIA Technology Services Ltd. are requesting permission to continue to receive and process pseudonymised record-level HES Data and Mortality Data.

IQVIA Ltd. and IQVIA Technology Services Ltd. use pseudonymised, monthly refreshed Hospital Episode Statistics Data comprising of Admitted Patient Care, Outpatients and Accident and Emergency datasets, alongside Civil Registry mortality data and Summary Hospital-level Mortality Indicator (SHMI) data to undertake analysis, develop services and provide solutions to providers of Healthcare and life sciences services such as:

• Clinical Commissioning Groups (CCGs)

• Commissioning Support Units (CSU’s)

• Hospital Trusts

• Private secondary care providers

• Mental Health trusts

• Community Provider Trusts

• Pharmacies

• NHS England

• Public Health England

• Sustainability and Transformation Partnerships (STPs)

• NHS Trusts

• Clinical teams

• Health and Wellbeing Boards

• Universities

• Life science industry

• Pharmaceutical companies

• Medical Device companies

• Industry bodies – limited to the Association of the British Pharmaceutical Industry (ABPI), Ethical Medicines Industry Group (EMIG) and the Proprietary Associated of Great Britain (PAGB)

IQVIA Ltd. and IQVIA Technology Services Ltd. request Civil Registration Mortality data linked to HES data, alongside SHMI data to support existing work and to develop new analyses about outcomes which will, in turn enable deeper insights into healthcare, for example a better understanding of the impact of variations in healthcare. To build on the work completed using the Civil Registration Data, IQVIA Ltd. and IQVIA Technology Services Ltd. request the Summary Hospital Mortality Indicator. This will enable IQVIA Ltd. and IQVIA Technology Services Ltd. to better inform NHS Trusts and help with the investigations where mortality is higher than expected.

IQVIA Ltd. and IQVIA Technology Services Ltd. request to continue to hold back Data for 5 complete data years, to conduct longitudinal disease burden, rare disease and outcome analysis. IQVIA will determine the maximum amount of Data necessary for each project.

The HES Data enables IQVIA Ltd. and IQVIA Technology Services Ltd. to provide services and solutions to its customers which include analysis, interpretation and reports. Those analyses, interpretations and reports assist such customers in supporting the understanding of care pathways, delivering clarity to hospitals on their use of medicines, enabling the development of diagnostic algorithms, enabling patients to be recruited to trials, and supporting healthcare commissioners and providers in achieving exceptional Data quality. These services will enable the development of health economic models that evaluate care delivery in relation to outcomes achieved for the patient and in so doing, help advance and benefit healthcare in a variety of different ways.

IQVIA Ltd. and IQVIA Technology Services Ltd. also utilise these HES Data to provide services to commercial organisations within the life sciences industry such as pharmaceutical, medical device and patient organisations, as well as healthcare charities and industry bodies. These organisations use the outputs and insights provided by IQVIA Ltd. and IQVIA Technology Services Ltd. to improve healthcare and assist the efficiency of the National Health Service. The use of the Data supports the development of innovative solutions and service improvement and helps to track outcomes and provide real-world evidence as required by the NHS, NICE, and NHS England with the aim of improving patient care and support enhanced access to improved services and innovative solutions. In addition, these customers use these outputs for the purposes of providing supporting information required by the NHS for business cases, epidemiological research, pathway analysis, burden of disease analysis, health economic research, predictive analytical modelling, NICE submissions and quality and outcome analysis, the outputs of which are shared directly or indirectly with the NHS to support improvements in patient care.

The Legal basis for processing of personal data relating to patient health is under Article 9(2)(j)of the GDPR - Processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. The data subjects’ interests and fundamental rights are protected through appropriate minimisation of fields; protection of the data in a secure environment and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project.

IQVIA Ltd. and IQVIA Technology Services Ltd. are processing the data in line with their goals as part of their legitimate interests. This is covered under the GDPR Article 6(1)(f) - This work is necessary for the purposes of the legitimate interests pursued by the controller except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child.

As set out in the legitimate interest assessment - the data requested is to help achieve the following examples:

Care Pathway Analysis,

Hospital Feedback services,

Benchmarking,

Diagnostic algorithm development studies,

Epidemiology studies,

Health economics and outcomes research studies,

Trust data quality reviews,

Clinical trial analysis.

The use of the data allows IQVIA Ltd. and IQVIA Technology Services Ltd. as part of their Legitimate Interests to provide services to improve healthcare for citizen’s and provide support services to healthcare providers to enable them to deliver better healthcare. This includes analysis and interpretation which provide understanding of care pathways, understanding use of medicines, recruiting patients to trials, and supporting healthcare commissioners and providers in achieving data quality, all these examples are with the aim of improving overall healthcare.

IQVIA Ltd. and IQVIA Technology Services Ltd. also utilise this Pseudonymised data to provide services to commercial organisations to improve healthcare and assist the efficiency of the National Health Service in the interest of public health. The service supports the development of innovative solutions and service improvement and helps to track outcomes and provide real-world evidence as required by the NHS, NICE, and NHS England with the aim of improving patient care and support enhanced access to improved services and innovative solutions. In addition, IQVIA Ltd. and IQVIA Technology Services Ltd. have found no evidence that the use of this data negatively impacts the fundamental rights and freedoms of the data subjects. Individuals have got the right to opt out of the use of this data.

All data passed on is small number suppressed as per HES Analytics guide.

IQVIA Ltd. and IQVIA Technology Services Ltd. will use the Data to perform two types of services (together these services are known as the “Permitted Services"):

1. Data Visualisation and Benchmarking (the "Service 1" services). This is a suite of software tools into which the relevant Data is loaded, which enables users to view metrics using tables, maps and charts. All outputs are aggregated with small numbers suppressed in line with the HES Analysis Guide.

Specific examples of these Service 1 services include:

i) Care Pathway Analysis

ii) Hospital Feedback services

iii) Visualise Healthcare Data, Healthcare Optimisation Benchmarking

Service 1 is managed via one or more appropriate software tools which are controlled and auditable. These software tools are used to display Data, with Data aggregated in line with the HES analysis guide. Any such software tool will allow users to perform analyses on aggregated Data and data from other sources and then view graphs and tables. Anyone using these software tools must enter into a contract the terms of which provide that they only use the Data for the purposes covered in this Data Sharing Agreement.

2) Advanced Statistical Analysis (the “Service 2” services) is bespoke analysis for external organisations on a project by project basis.

Typical examples of the Permitted Services are described below:

Service 1: Data visualisation and benchmarking:

i) Care Pathway Analysis (CPA). Presents users with simple views of aggregated care pathways. This allows investigation of the causes of variation in patient pathways and the subsequent impact on service delivery with the aim to improve healthcare provision.

ii) Hospital Feedback Services (HFS). A dashboard assisting chief pharmacists in the optimisation of their use of medicines. It will allow them to monitor their own performance against internal targets and benchmark against similar hospitals. NHS Trusts are granted access to HFS in exchange for continued supply of non-identifiable prescription Data to IQVIA and agreement that IQVIA can use the Data for more further research.

iii) Visualise Healthcare Data (VHD). A suite of software tools / reports / dashboards, that allows users to perform queries on aggregated HES Data and data from other sources which they can then view as graphs and tables. The Data can be used to enable a Trust to compare its performance to other Trusts against a range of clinical indicators and identify where it could make improvements in the delivery of care to patients. A Sustainability and Transformation Partnership (STP) or Trust may also wish to use the Data to analyse at a regional and local level how best how to manage its resources in response to changes in demand and understand the scope of the changes it would need to make to improve patient care.

iv, Trust data quality reviews - Review of a Trust’s coding data quality against recognised NHS Standards. Data quality reviews generate insights for Hospital Trusts and help improve the consistency of clinical coding. Resulting benchmarking insights facilitate data quality improvements across NHS Trusts.

Service 2: Advanced Statistical Analysis bespoke analysis on a project by project basis, such as:

i, Diagnostic algorithm development studies - Machine learning and artificial intelligence to develop algorithms to diagnose patients,

ii, Epidemiology studies - The study and analysis of the distribution patterns and determinants of health and disease conditions in defined populations,

iii, Health economics and outcomes research studies - The study of the value of treatments and the health benefits they deliver to enable doctors to make decisions about the best treatment pathway for patients,

iv, Clinical trial analysis – advanced analytics techniques like machine learning and artificial intelligence may be utilised for predictive algorithm development to identify undiagnosed patients and patients at-risk of disease progression for clinical research enrolment (clinical trials, late phase observational studies) and for healthcare management support that can include disease screening, treatment suitability, treatment response and adherence.

Service 2 may utilise machine learning and artificial intelligence approaches for predictive algorithm development.

Previously, every research study (ie i, ii, iii, iv & v listed above) provided via Service 2 goes to the IQVIA Independent Scientific Advisory Committee (ISEAC) for approval, and IQVIA were not required to provide the specific details of each project within the DSA. However, from the subsequent iteration of this Agreement IQVIA will be required to outline the specific details of projects using data disseminated under this DSA.

The number of organisations to which IQVIA Ltd. and IQVIA Technology Services Ltd. provides products and services changes regularly. Under the 2018/2019 DSA, the data controllers have worked on in excess of 30 projects using this HES Data. Of these projects, approximately half were for repeat customers (i.e. who had purchased at least one other software tool or project from IQVIA within that period).

All outputs of the Data are aggregated with small numbers suppressed in line with the HES analysis guide. The Data Controllers understands the importance of data minimisation and minimises the Data used on a study by study basis.

The insights and analysis may be at national level or provided at a lower level of detail if required (with the suppression rules of NHS Digital applied to the output). IQVIA Ltd. and IQVIA Technology Services Ltd. require national and historical HES Data for the following reasons:

1. IQVIA Ltd. and IQVIA Technology Services Ltd. require national Data to enable the end users of IQVIA software tools to benchmark against organisations in their local area or with similar demographic characteristics. IQVIA Ltd. and IQVIA Technology Services Ltd. also require national Data to inform economic analyses for inclusion in submissions to NICE, which makes decisions at a national level.

2. IQVIA Ltd. and IQVIA Technology Services Ltd. require national Data for Hospital Feedback Service which is for all chief pharmacists in all NHS Trusts.

3. Historic Data is required to support Advanced Statistical Analysis projects, as historical Data allows robust analysis of trends over time.

IQVIA Ltd. and IQVIA Technology Services Ltd. undertake numerous ongoing projects using HES on a yearly basis; approximately 30 distinct projects using such Data were completed in 2018/19. The outputs are varied and in different formats, ranging from dashboards, reports, charts, and models to analysis, research papers and publications. These outputs are intended to achieve benefits to healthcare, including changes in patient care, reduction in costs, uptake and monitoring of policy.

Examples of outputs expected from projects for each of the services are given below:

SERVICE 1: Data visualisation and benchmarking (all Data used in Service 1 is aggregated, small number suppressed in line with the HES analysis guidelines):

Care Pathway Analysis (CPA): CPA is a service either deployed directly to users or used to support consulting projects. In the former case, users are given role-based access to a software tool which will allow them to analyse images of aggregated pathways. In the latter case, outputs will be presentations and reports containing pathway images as well as IQVIA recommendations.

Hospital Feedback Services (HFS): IQVIA has employed a chief pharmacist to provide feedback to hospital pharmacists and currently has approximately 120 Trusts signed up to receive Feedback reports; IQVIA seeks to expand further by engaging with more Trusts by promoting the reports available through networking, events and newsletters.

An example of the information IQVIA supply back into the Trusts is a report on the use of antibiotics by Defined Daily Dose per 1000 admissions (using admission Data from HES for the same month the year before) to show seasonal variation. This report is supplied to the Regional Medicines Optimisation Committees, and Trust Chief Pharmacists can benchmark their own trust against a peer benchmark group of trusts.

Visualise Healthcare Data (VHD): Users are given role-based access to the software tools which allow users to produce graphical and tabular estimates of burden of disease, cost of care, common comorbidities and similar analyses. These analyses may be stratified by diagnosis, organisation and other similar parameters.

VHD includes Cohort Builder reporting, which includes stratification by disease and therapy counts (patients and events), gender, age grouping, events over time and geographical based counts (if available) in line with the current purpose of this DSA.

Other VHD software tools offer nuances of these stratifications including event (diagnosis or therapy types) based breakdowns of medical event counts, user definable age ranges, recruitment models over time with user definable variables, and various visualisations to describe treatment patterns or disease progression using aggregated small number suppressed Data only.

Healthcare optimization Benchmarking:

Provides benchmarking capabilities enabling peer to peer and national comparisons across a range of clinical, financial and operational measures. This will be further enhanced with the use of the Summary Hospital Level Mortality data to enable SHMI comparisons to be made, in conjunction with related benchmarked measures.

SERVICE 2: Advanced Statistical Analysis:

The Data outputs in advanced statistical analysis are always aggregated and small number suppressed in line with the HES Analysis Guide. These outputs are produced to meet different objectives and delivered in different ways.

A health economic analysis may require analysis of the Data to estimate the cost of managing a given condition then used as an input in an economic model for a NICE submission. Developing a diagnostic algorithm will result in the production of a formula which may be presented to clinicians in an Excel based calculator with an explanatory report or presentation. For the case of identification of undiagnosed and/or at-risk patients, clinical trials analysis, predictive models will be developed to determine eligibility for a clinical intervention as part of clinical research participation or healthcare management. The reports that will be generated will inform clinical trial / observational study design and planning.

Data quality reviews generate actionable insights for Hospital Trusts and support the improvement and consistency of clinical coding. Good data quality is extremely important to accurate benchmarking and performance analysis. Benchmarking these insights will facilitate data quality improvements across NHS Trusts. Organisations can then review and refine their service delivery to support patient outcomes in line with national and local quality indicators.

Data will be used to determine eligibility for taking part in clinical research. The reports that will be generated will inform clinical trial / observational study design and planning.

Many of the outputs of advanced statistical analysis are reported in journal articles or conference presentations.

MORTALITY DATA:

When completing any analysis in a healthcare or life science project to generate insights and learning, it is important to ensure that all relevant factors that influence a patient’s health and well-being are considered. For example, when a patient has passed away, it is important to understand all the clinical and demographic circumstances surrounding that loss of life to ensure that all that can be learned is uncovered from any retrospective analysis of the Data. A comprehensive understanding of the contributing factors in that loss of life is critical in understanding whether the life lost was avoidable or whether the services delivered to such patient could have been provided in a more effective way.

Analysis of Mortality Data would provide a different perspective enabling IQVIA to better understand observed patterns in mortality with the aim of improving outcomes. This perspective of the data would enable the identification of patterns within service delivery linked to mortality to facilitate investigation and benchmarking of links between service delivery and death outcomes.

An example of using the Mortality Data is that it will allow IQVIA to implement SHMI calculations in its benchmarking solution, allowing Trusts to view a SHMI for custom patient groups in addition to the hospital and site wide-indicators available via NHS Digital. By allowing Trusts to look at SHMI for specialties, or large patient cohorts, the NHS organisations e will have a greater visibility of SHMI statistics and how these look at the specialty level. This greater visibility of SHMI information will allow NHS Trusts to focus on areas where deaths are higher than expected and give them a tool to assist in identifying areas of care worthy of further investigation, as part of their efforts to improve healthcare and patient safety in their organisations. Our initial work has demonstrated that it is not possible to replicate the published SHMI numbers, as such we have requested the additional dataset to help us achieve this.

IQVIA have completed 29 HES based projects during 2019 and 28 projects in 2020 year to date, however, please note that due to the on-going nature of some projects and recurrent nature of others, some projects will appear in both 2019 and 2020 counts. Further, in respect of IQVIA services for “Data visualisation and Benchmarking”, during the year 2020 IQVIA continues to provide clinical coding benchmarking services to 20 NHS Clients and clients who provide healthcare services on behalf of NHS organisations, and also NHS performance benchmarking through the healthcare optimisation benchmarking service to 31 NHS organisations and organisations who provide healthcare services on behalf of NHS organisations.

Examples of yielded benefits from a sample of projects:

Large University Teaching Hospital in England – Integrated Service Analytics to understand Performance:

IQVIA Ltd. and IQVIA Technology Services Ltd. engaged with a large University Teaching Hospital in the Thames Valley region to investigate and provide a detailed explanation as to why the Trust had an observed loss of income that was proving difficult to explain and understand using ‘siloed’ systems within the Trust.

• Why was this issue important?

The issue had provided the Trust with a major challenge with regards to an unexplained loss of income that would need to be understood in detail to enable the Trust to improve performance. The Trust had two key questions to answer, namely;

Has anything changed within the depth of coding which impacts positively or adversely on Trust income at a specialty level? And;

The Trust seem to have reduced income without a corresponding reduction in patient numbers. Is there any evidence that this is due to a real shift in case mix, or is it due to factors such as coding, the grouper etc?

• What IQVIA Ltd. and IQVIA Technology Services Ltd. did:

The IQVIA team utilised National HES data to assess National level performance alongside utilising where appropriate local Trust data to complete a detailed audit at specialty level of clinical coding practices at the Trust, at the same time as benchmarking internal and external measures of performance with selected peer organisations. By completing the clinical coding review HES level performance analysis and benchmarking, IQVIA were able to deliver actionable insights to the Trust.

It was clearly identified that challenges around patient throughput, were the actual cause of falling revenue at the Hospital.

The project revealed an observed increase in emergency admissions through A&E with an extended period of non-elective pressure that impacted on patient flow, further, that observed improvements in non-elective spell length were being offset by an increase in non-elective admissions. Compounding this issue further was an observed growth in readmissions within 30 days across specialties where observed values exceeded those observed amongst peer Trusts. These excess readmissions were creating additional interference to efficient flow due to patient back flow.

Multiple challenges, if tackled, would improve patient flow and build upon the efficiency gains the Trust has achieved in the reduction of average spell length for non-elective admissions

• Benefits to Patient Care:

These multiple challenges, if tackled, would improve patient flow and build upon the efficiency gains the Trust has achieved in the reduction of average spell length for non-elective admissions.

In addition, the Trust would have the ability to increase elective throughput reducing waiting times and enabling improved access to care for local patients.

Large University Teaching Hospital in England – Integrated Service Analytics to understand Performance:

IQVIA Ltd. and IQVIA Technology Services Ltd. engaged with a large University Teaching Hospital in the South West London region to investigate and provide them with evidence-based areas for investigation with the Urology (LB) sub-chapter – Urological and Male Reproductive System Procedures and Disorders. The Trust had assessed their local performance in this area as requiring improvement and engaged IQVIA to support them in the identification of key issues.

• Why was this issue important?

The Trust wanted to identify ‘key lines of enquiry’ to support a ‘reduction in costs’ (or to generate additional legitimate income) focussing on Urology (HRG Sub Chapter LB) where the Trust had observed performance variances that were adversely higher than expected.

By tackling these challenges, the Trust anticipated they would improve access to key services for local patients, improve efficiency locally, and potentially increase the in-bound revenue for the Urological specialty.

• What IQVIA Ltd. and IQVIA Technology Services Ltd. did:

The IQVIA team utilised National HES data to asses National level performance alongside utilising where appropriate local Trust data to complete a specialty level review of coded clinical data at the Trust, at the same time as benchmarking internal and external measures of performance with selected peer organisations. By completing the HES level performance analysis and benchmarking review, IQVIA were able to deliver actionable insights to the Trust.

The HES based analysis and supporting work Identified focus areas for clinical and managerial attention to maximise the impact of service improvement effort. The work completed included identification of benchmarked statistically significant drivers of variance in comparison to Peer and National groups, for spell length, spell cost, theatre minutes and readmissions. From the completed review of the Urology specialty service, key areas requiring Trust attention included;

• Bladder oncology

• Renal Calculus

• Urinary Tract Infections

• Endoscopic resection of lesions of bladder

Further the Trust needed to support the development of pathways that would avoid admissions without a procedure taking place, and further, readmissions of patients within 30 days who have had a completed procedure to improve the overall patient flow

• Benefits to Patient Care:

The actionable insights delivered by the project enabled the Trust to utilise the evidence-based lines of enquiry to inform service business planning for 2020/21 enabling the Trust Urology team to focus on key areas that would support their drive on cost reduction at the Trust.

Patients would then be able to enjoy more efficient access to improved Urological services that were delivered efficiently and could allow the Trust to meet financial obligations whilst increasing the potential to re-invest in local services.

Large English Acute Hospital – Hyperacute stroke services to understand service delivery and performance relative to other HASU’s:

IQVIA engaged with the Trust to present a high-level review of benchmarked key performance indicators around the Acute Stroke Service, and summarised several potential key variations in performance measures, namely;

• Overall HRG Chapter AA showed variances by POD (Elective, Day Case and Non-elective admissions)

• Variances were observed in the day case rate

• High cost HRG’s and LOS variances were observed when compared to Peers and National averages

• Very high level of variance in ICD (Diagnosis) weighting compared to the selected Peers and National average

The Trust were also keen to understand the observed high level of patient readmissions to the Trust across all specialty areas. The Trust engaged IQVIA to support them in understanding the key issues around the stroke service and to investigate readmissions

• Why was this issue important?

The Trust length of stay although below the overall national average was higher than other similar peer organisations who were delivering an observed lower length of stay. The Trust wanted to ensure HASU bed capacity, changes to case mix complexity or other “bottlenecks” on patient flow could be identified to ensure access to services remained high.

The Trust were keen to minimise the need for patients to be re-admitted to Hospital within 30 days following discharge, were this occurs it is likely to represent a difficult patient experience and add significantly to the resource burden of the Trust if this occurs with greater than expected frequency.

• What IQVIA Ltd. and IQVIA Technology Services Ltd. did:

IQVIA utilised Trust supplied data assets and National Hospital Episode Statistics (HES data), to complete a deep dive review of the Stroke service and Hospital Readmissions on behalf of the Trust. The analysis examined the stroke service and readmissions following stroke and readmissions in a wider Trust context across the service portfolio of the Hospital.

For stroke diagnosis code defined patients, based on the volume of admissions to the analysed Units, IQVIA used these defined Units as a basis for comparison of multiple performance measures within a detailed HES data analysis, also utilising Trust supplied data to examine and review clinical coding information at a benchmarked National, and local level. Additional benchmarking tools utilising National data enabled detailed review of stroke services performance indicators and detailed analysis of readmissions.

Observed percentage readmission rates at the Trust were high relative to peer organisations and National benchmarks, for example, and Trust clinical teams managed 54 readmissions within 30 days of discharge following an acute stroke, with cerebral infarction identified as the most common recorded reason for patient readmission.

The avoidance of readmissions even where the readmission results in a zero length of stay, will still impact on Trust resources (particularly A&E), and add to the pressures experienced across the emergency department. The results of the project should help the Trust to focus on key areas for improvement.

Benefits to Patient Care:

The project focused on investigating a national and local view of stroke related activity for designated HASU's and the impact of variation in key measures. These insights were distilled into a highly focused report to initiate Trust service improvements. Locally future patients would benefit from the Trust implementing;

A comprehensive performance framework to monitor upstream patient flow to;

• Assess likely future demand for stroke services across a wider geography

• Liaise with and support primary care management of stroke “at risk” patients in the system

The Trust utilising the ‘stroke service’ as a “pilot” service for a review of discharge processes that could be rolled out across all Trust specialties following initial implementation and post-implementation review by Trust service teams.

IQVIA is a business comprising of several legal entities which provide information, technology and services to healthcare. IQVIA Ltd. and IQVIA Technology Services Ltd. are two of the legal entities which are part of the IQVIA group. Under this agreement IQVIA Ltd. and IQVIA Technology Services Ltd. are requesting permission to continue to use and receive pseudonymised record-level HES Data and Mortality Data.

IQVIA Ltd. and IQVIA Technology Services Ltd. use pseudonymised, monthly refreshed Hospital Episode Statistics Data comprising of Admitted Patient Care, Outpatients and Accident and Emergency datasets, alongside Civil Registry mortality data to undertake analysis, develop services and provide solutions to providers of Healthcare and life sciences services such as:

• Clinical Commissioning Groups (CCGs)

• Commissioning Support Units (CSU’s)

• Hospital Trusts

• Private secondary care providers

• Mental Health trusts

• Community Provider Trusts

• Pharmacies

• NHS England

• Public Health England

• Sustainability and Transformation Partnerships (STPs)

• NHS Trusts

• Clinical teams

• Health and Wellbeing Boards

• Universities

• Life science industry

• Pharmaceutical companies

• Medical Device companies

• Industry bodies – limited to the Association of the British Pharmaceutical Industry (ABPI), Ethical Medicines Industry Group (EMIG) and the Proprietary Associated of Great Britain (PAGB)

IQVIA Ltd and IQVIA Technology Services Ltd request Civil Registration Mortality data linked to HES data, alongside SHMI data to support existing work and to develop new analyses about outcomes which will, in turn enable deeper insights into healthcare, for example a better understanding of the impact of variations in healthcare. To build on the work completed using the Civil Registration Data, IQVIA Ltd. and IQVIA Technology Services Ltd. request the Summary Hospital Mortality Indicator. This will enable IQVIA Ltd. and IQVIA Technology Services Ltd. to better inform NHS Trusts and help with the investigations where mortality is higher than expected.

IQVIA Ltd. and IQVIA Technology Services Ltd. request to continue to hold back Data for 5 complete data years, to conduct longitudinal disease burden, rare disease and outcome analysis. IQVIA will determine the maximum amount of Data necessary for each project.

The HES Data enables IQVIA Ltd. and IQVIA Technology Services Ltd. to provide services and solutions to its customers which include analysis, interpretation and reports. Those analyses, interpretations and reports assist such customers in supporting the understanding of care pathways, delivering clarity to hospitals on their use of medicines, enabling the development of diagnostic algorithms, enabling patients to be recruited to trials, and supporting healthcare commissioners and providers in achieving exceptional Data quality. These services will enable the development of health economic models that evaluate care delivery in relation to outcomes achieved for the patient and in so doing, help advance and benefit healthcare in a variety of different ways.

IQVIA Ltd. and IQVIA Technology Services Ltd. also utilise these HES Data to provide services to commercial organisations within the life sciences industry such as pharmaceutical, medical device and patient organisations, as well as healthcare charities and industry bodies. These organisations use the outputs and insights provided by IQVIA Ltd. and IQVIA Technology Services Ltd. to improve healthcare and assist the efficiency of the National Health Service. The use of the Data supports the development of innovative solutions and service improvement and helps to track outcomes and provide real-world evidence as required by the NHS, NICE, and NHS England with the aim of improving patient care and support enhanced access to improved services and innovative solutions. In addition, these customers use these outputs for the purposes of providing supporting information required by the NHS for business cases, epidemiological research, pathway analysis, burden of disease analysis, health economic research, predictive analytical modelling, NICE submissions and quality and outcome analysis, the outputs of which are shared directly or indirectly with the NHS to support improvements in patient care.

The Legal basis for processing of personal data relating to patient health is under Article 9(2)(j)of the GDPR - Processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. The data subjects’ interests and fundamental rights are protected through appropriate minimisation of fields; protection of the data in a secure environment and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project.

IQVIA Ltd. and IQVIA Technology Services Ltd are processing the data in line with their goals as part of their legitimate interests. This is covered under the GDPR Article 6(1)(f) - This work is necessary for the purposes of the legitimate interests pursued by the controller except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child.

As set out in the legitimate interest assessment - the data requested is to help achieve the following examples:

Care Pathway Analysis,

Hospital Feedback services,

Benchmarking,

Diagnostic algorithm development studies,

Epidemiology studies,

Health economics and outcomes research studies,

Trust data quality reviews,

Clinical trial analysis.

The use of the data allows IQVIA Ltd. and IQVIA Technology Services Ltd as part of their Legitimate Interests to provide services to improve healthcare for citizen’s and provide support services to healthcare providers to enable them to deliver better healthcare. This includes analysis and interpretation which provide understanding of care pathways, understanding use of medicines, recruiting patients to trials, and supporting healthcare commissioners and providers in achieving data quality, all these examples are with the aim of improving overall healthcare.

IQVIA Ltd. and IQVIA Technology Services Ltd also utilise this Pseudonymised data to provide services to commercial organisations to improve healthcare and assist the efficiency of the National Health Service in the interest of public health. The service supports the development of innovative solutions and service improvement and helps to track outcomes and provide real-world evidence as required by the NHS, NICE, and NHS England with the aim of improving patient care and support enhanced access to improved services and innovative solutions. In addition, IQVIA Ltd. and IQVIA Technology Services Ltd have found no evidence that the use of this data negatively impacts the fundamental rights and freedoms of the data subjects. Individuals have got the right to opt out of the use of this data.

All data passed on is small number suppressed as per HES Analytics guide.

IQVIA Ltd. and IQVIA Technology Services Ltd. will use the Data to perform two types of services (together these services are known as the “Permitted Services"):

1. Data Visualisation and Benchmarking (the "Service 1" services). This is a suite of software tools into which the relevant Data is loaded, which enables users to view metrics using tables, maps and charts. All outputs are aggregated with small numbers suppressed in line with the HES Analysis Guide.

Specific examples of these Service 1 services include:

i) Care Pathway Analysis

ii) Hospital Feedback services

iii) Visualise Healthcare Data, Healthcare Optimisation Benchmarking

Service 1 is managed via one or more appropriate software tools which are controlled and auditable. These software tools are used to display Data, with Data aggregated in line with the HES analysis guide. Any such software tool will allow users to perform analyses on aggregated Data and data from other sources and then view graphs and tables. Anyone using these software tools must enter into a contract the terms of which provide that they only use the Data for the purposes covered in this Data Sharing Agreement.

2) Advanced Statistical Analysis (the “Service 2” services) is bespoke analysis for external organisations on a project by project basis.

Typical examples of the Permitted Services are described below:

Service 1: Data visualisation and benchmarking:

i) Care Pathway Analysis (CPA). Presents users with simple views of aggregated care pathways. This allows investigation of the causes of variation in patient pathways and the subsequent impact on service delivery with the aim to improve healthcare provision.

ii) Hospital Feedback Services (HFS). A dashboard assisting chief pharmacists in the optimisation of their use of medicines. It will allow them to monitor their own performance against internal targets and benchmark against similar hospitals. NHS Trusts are granted access to HFS in exchange for continued supply of non-identifiable prescription Data to IQVIA and agreement that IQVIA can use the Data for more further research.

iii) Visualise Healthcare Data (VHD). A suite of software tools / reports / dashboards, that allows users to perform queries on aggregated HES Data and data from other sources which they can then view as graphs and tables. The Data can be used to enable a Trust to compare its performance to other Trusts against a range of clinical indicators and identify where it could make improvements in the delivery of care to patients. A Sustainability and Transformation Partnership (STP) or Trust may also wish to use the Data to analyse at a regional and local level how best how to manage its resources in response to changes in demand and understand the scope of the changes it would need to make to improve patient care.

iv, Trust data quality reviews - Review of a Trust’s coding data quality against recognised NHS Standards. Data quality reviews generate insights for Hospital Trusts and help improve the consistency of clinical coding. Resulting benchmarking insights facilitate data quality improvements across NHS Trusts.

Service 2: Advanced Statistical Analysis bespoke analysis on a project by project basis, such as:

i, Diagnostic algorithm development studies - Machine learning and artificial intelligence to develop algorithms to diagnose patients,

ii, Epidemiology studies - The study and analysis of the distribution patterns and determinants of health and disease conditions in defined populations,

iii, Health economics and outcomes research studies - The study of the value of treatments and the health benefits they deliver to enable doctors to make decisions about the best treatment pathway for patients,

iv, Clinical trial analysis – advanced analytics techniques like machine learning and artificial intelligence may be utilised for predictive algorithm development to identify undiagnosed patients and patients at-risk of disease progression for clinical research enrolment (clinical trials, late phase observational studies) and for healthcare management support that can include disease screening, treatment suitability, treatment response and adherence.

Service 2 may utilise machine learning and artificial intelligence approaches for predictive algorithm development.

Every research study (ie i, ii, iii, iv & v listed above) provided via Service 2 goes to the IQVIA Independent Scientific Advisory Committee (ISEAC) for approval. More details about ISEAC appear in the next section.

The number of organisations to which IQVIA Ltd. and IQVIA Technology Services Ltd. provides products and services changes regularly. Under the 2018/2019 DSA, the data controllers have worked on in excess of 30 projects using this HES Data. Of these projects, approximately half were for repeat customers (i.e. who had purchased at least one other software tool or project from IQVIA within that period).

All outputs of the Data are aggregated with small numbers suppressed in line with the HES analysis guide. the Data Controllers understands the importance of data minimisation and minimises the Data used on a study by study basis.

The insights and analysis may be at national level or provided at a lower level of detail if required (with the suppression rules of NHS Digital applied to the output). IQVIA Ltd. and IQVIA Technology Services Ltd. require national and historical HES Data for the following reasons:

1. IQVIA Ltd. and IQVIA Technology Services Ltd. require national Data to enable the end users of IQVIA software tools to benchmark against organisations in their local area or with similar demographic characteristics. IQVIA Ltd. and IQVIA Technology Services Ltd. also require national Data to inform economic analyses for inclusion in submissions to NICE, which makes decisions at a national level.

2. IQVIA Ltd. and IQVIA Technology Services Ltd. require national Data for Hospital Feedback Service which is for all chief pharmacists in all NHS Trusts.

3. Historic Data is required to support Advanced Statistical Analysis projects, as historical Data allows robust analysis of trends over time.

IQVIA Ltd. and IQVIA Technology Services Ltd. undertake numerous ongoing projects using HES on a yearly basis; approximately 30 distinct projects using such Data were completed in 2018/19. The outputs are varied and in different formats, ranging from dashboards, reports, charts, and models to analysis, research papers and publications. These outputs are intended to achieve benefits to healthcare, including changes in patient care, reduction in costs, uptake and monitoring of policy.

Examples of outputs expected from projects for each of the services are given below:

SERVICE 1: Data visualisation and benchmarking (all Data used in Service 1 is aggregated, small number suppressed in line with the HES analysis guidelines):

Care Pathway Analysis (CPA): CPA is a service either deployed directly to users or used to support consulting projects. In the former case, users are given role-based access to a software tool which will allow them to analyse images of aggregated pathways. In the latter case, outputs will be presentations and reports containing pathway images as well as IQVIA recommendations.

Hospital Feedback Services (HFS): IQVIA has employed a chief pharmacist to provide feedback to hospital pharmacists and currently has approximately 120 Trusts signed up to receive Feedback reports; IQVIA seeks to expand further by engaging with more Trusts by promoting the reports available through networking, events and newsletters.

An example of the information IQVIA supply back into the Trusts is a report on the use of antibiotics by Defined Daily Dose per 1000 admissions (using admission Data from HES for the same month the year before) to show seasonal variation. This report is supplied to the Regional Medicines Optimisation Committees, and Trust Chief Pharmacists can benchmark their own trust against a peer benchmark group of trusts.

Visualise Healthcare Data (VHD): Users are given role-based access to the software tools which allow users to produce graphical and tabular estimates of burden of disease, cost of care, common comorbidities and similar analyses. These analyses may be stratified by diagnosis, organisation and other similar parameters.

VHD includes Cohort Builder reporting, which includes stratification by disease and therapy counts (patients and events), gender, age grouping, events over time and geographical based counts (if available) in line with the current purpose of this DSA.

Other VHD software tools offer nuances of these stratifications including event (diagnosis or therapy types) based breakdowns of medical event counts, user definable age ranges, recruitment models over time with user definable variables, and various visualisations to describe treatment patterns or disease progression using aggregated small number suppressed Data only.

Healthcare optimization Benchmarking:

Provides benchmarking capabilities enabling peer to peer and national comparisons across a range of clinical, financial and operational measures. This will be further enhanced with the use of the Summary Hospital Level Mortality data to enable SHMI comparisons to be made, in conjunction with related benchmarked measures.

SERVICE 2: Advanced Statistical Analysis:

The Data outputs in advanced statistical analysis are always aggregated and small number suppressed in line with the HES Analysis Guide. These outputs are produced to meet different objectives and delivered in different ways.

A health economic analysis may require analysis of the Data to estimate the cost of managing a given condition then used as an input in an economic model for a NICE submission. Developing a diagnostic algorithm will result in the production of a formula which may be presented to clinicians in an Excel based calculator with an explanatory report or presentation. For the case of identification of undiagnosed and/or at-risk patients, clinical trials analysis, predictive models will be developed to determine eligibility for a clinical intervention as part of clinical research participation or healthcare management. The reports that will be generated will inform clinical trial / observational study design and planning.

Data quality reviews generate actionable insights for Hospital Trusts and support the improvement and consistency of clinical coding. Good data quality is extremely important to accurate benchmarking and performance analysis. Benchmarking these insights will facilitate data quality improvements across NHS Trusts. Organisations can then review and refine their service delivery to support patient outcomes in line with national and local quality indicators.

Data will be used to determine eligibility for taking part in clinical research. The reports that will be generated will inform clinical trial / observational study design and planning.

Many of the outputs of advanced statistical analysis are reported in journal articles or conference presentations.

MORTALITY DATA:

When completing any analysis in a healthcare or life science project to generate insights and learning, it is important to ensure that all relevant factors that influence a patient’s health and well-being are considered. For example, when a patient has passed away, it is important to understand all the clinical and demographic circumstances surrounding that loss of life to ensure that all that can be learned is uncovered from any retrospective analysis of the Data. A comprehensive understanding of the contributing factors in that loss of life is critical in understanding whether the life lost was avoidable or whether the services delivered to such patient could have been provided in a more effective way.

Analysis of Mortality Data would provide a different perspective enabling IQVIA to better understand observed patterns in mortality with the aim of improving outcomes. This perspective of the data would enable the identification of patterns within service delivery linked to mortality to facilitate investigation and benchmarking of links between service delivery and death outcomes.

An example of using the Mortality Data is that it will allow IQVIA to implement SHMI calculations in its benchmarking solution, allowing Trusts to view a SHMI for custom patient groups in addition to the hospital and site wide-indicators available via NHS Digital. By allowing Trusts to look at SHMI for specialties, or large patient cohorts, the NHS organisations e will have a greater visibility of SHMI statistics and how these look at the specialty level. This greater visibility of SHMI information will allow NHS Trusts to focus on areas where deaths are higher than expected and give them a tool to assist in identifying areas of care worthy of further investigation, as part of their efforts to improve healthcare and patient safety in their organisations. Our initial work has demonstrated that it is not possible to replicate the published SHMI numbers, as such we have requested the additional dataset to help us achieve this.

SEPTEMBER 2020 AMENDMENT:

IQVIA have completed 29 HES based projects during 2019 and 28 projects in 2020 year to date, however, please note that due to the on-going nature of some projects and recurrent nature of others, some projects will appear in both 2019 and 2020 counts. Further, in respect of IQVIA services for “Data visualisation and Benchmarking”, during the year 2020 IQVIA continues to provide clinical coding benchmarking services to 20 NHS Clients and clients who provide healthcare services on behalf of NHS organisations, and also NHS performance benchmarking through the healthcare optimisation benchmarking service to 31 NHS organisations and organisations who provide healthcare services on behalf of NHS organisations

Examples of yielded benefits from a sample of projects:

Large University Teaching Hospital in England – Integrated Service Analytics to understand Performance:

IQVIA Ltd engaged with a large University Teaching Hospital in the Thames Valley region to investigate and provide a detailed explanation as to why the Trust had an observed loss of income that was proving difficult to explain and understand using ‘siloed’ systems within the Trust.

• Why was this issue important?

The issue had provided the Trust with a major challenge with regards to an unexplained loss of income that would need to be understood in detail to enable the Trust to improve performance. The Trust had two key questions to answer, namely;

Has anything changed within the depth of coding which impacts positively or adversely on Trust income at a specialty level? And;

The Trust seem to have reduced income without a corresponding reduction in patient numbers. Is there any evidence that this is due to a real shift in case mix, or is it due to factors such as coding, the grouper etc?

• What IQVIA Ltd. and IQVIA Technology Services Ltd. did:

The IQVIA team utilised National HES data to asses National level performance alongside utilising where appropriate local Trust data to complete a detailed audit at specialty level of clinical coding practices at the Trust, at the same time as benchmarking internal and external measures of performance with selected peer organisations. By completing the clinical coding review HES level performance analysis and benchmarking, IQVIA were able to deliver actionable insights to the Trust.

It was clearly identified that challenges around patient throughput, were the actual cause of falling revenue at the Hospital.

The project revealed an observed increase in emergency admissions through A&E with an extended period of non-elective pressure that impacted on patient flow, further, that observed improvements in non-elective spell length were being offset by an increase in non-elective admissions. Compounding this issue further was an observed growth in readmissions within 30 days across specialties where observed values exceeded those observed amongst peer Trusts. These excess readmissions were creating additional interference to efficient flow due to patient back flow.

Multiple challenges, if tackled, would improve patient flow and build upon the efficiency gains the Trust has achieved in the reduction of average spell length for non-elective admissions

• Benefits to Patient Care:

These multiple challenges, if tackled, would improve patient flow and build upon the efficiency gains the Trust has achieved in the reduction of average spell length for non-elective admissions.

In addition, the Trust would have the ability to increase elective throughput reducing waiting times and enabling improved access to care for local patients.

Large University Teaching Hospital in England – Integrated Service Analytics to understand Performance:

IQVIA Ltd engaged with a large University Teaching Hospital in the South West London region to investigate and provide them with evidence-based areas for investigation with the Urology (LB) sub-chapter – Urological and Male Reproductive System Procedures and Disorders. The Trust had assessed their local performance in this area as requiring improvement and engaged IQVIA to support them in the identification of key issues.

• Why was this issue important?

The Trust wanted to identify ‘key lines of enquiry’ to support a ‘reduction in costs’ (or to generate additional legitimate income) focussing on Urology (HRG Sub Chapter LB) where the Trust had observed performance variances that were adversely higher than expected.

By tackling these challenges, the Trust anticipated they would improve access to key services for local patients, improve efficiency locally, and potentially increase the in-bound revenue for the Urological specialty.

• What IQVIA Ltd. and IQVIA Technology Services Ltd. did:

The IQVIA team utilised National HES data to asses National level performance alongside utilising where appropriate local Trust data to complete a specialty level review of coded clinical data at the Trust, at the same time as benchmarking internal and external measures of performance with selected peer organisations. By completing the HES level performance analysis and benchmarking review, IQVIA were able to deliver actionable insights to the Trust.

The HES based analysis and supporting work Identified focus areas for clinical and managerial attention to maximise the impact of service improvement effort. The work completed included identification of benchmarked statistically significant drivers of variance in comparison to Peer and National groups, for spell length, spell cost, theatre minutes and readmissions. From the completed review of the Urology specialty service, key areas requiring Trust attention included;

• Bladder oncology

• Renal Calculus

• Urinary Tract Infections

• Endoscopic resection of lesions of bladder

Further the Trust needed to support the development of pathways that would avoid admissions without a procedure taking place, and further, readmissions of patients within 30 days who have had a completed procedure to improve the overall patient flow

• Benefits to Patient Care:

The actionable insights delivered by the project enabled the Trust to utilise the evidence-based lines of enquiry to inform service business planning for 2020/21 enabling the Trust Urology team to focus on key areas that would support their drive on cost reduction at the Trust.

Patients would then be able to enjoy more efficient access to improved Urological services that were delivered efficiently and could allow the Trust to meet financial obligations whilst increasing the potential to re-invest in local services.

Large English Acute Hospital – Hyperacute stroke services to understand service delivery and performance relative to other HASU’s:

IQVIA engaged with the Trust to present a high-level review of benchmarked key performance indicators around the Acute Stroke Service, and summarised several potential key variations in performance measures, namely;

• Overall HRG Chapter AA showed variances by POD (Elective, Day Case and Non-elective admissions)

• Variances were observed in the day case rate

• High cost HRG’s and LOS variances were observed when compared to Peers and National averages

• Very high level of variance in ICD (Diagnosis) weighting compared to the selected Peers and National average

The Trust were also keen to understand the observed high level of patient readmissions to the Trust across all specialty areas. The Trust engaged IQVIA to support them in understanding the key issues around the stroke service and to investigate readmissions

• Why was this issue important?

The Trust length of stay although below the overall national average was higher than other similar peer organisations who were delivering an observed lower length of stay. The Trust wanted to ensure HASU bed capacity, changes to case mix complexity or other “bottlenecks” on patient flow could be identified to ensure access to services remained high.

The Trust were keen to minimise the need for patients to be re-admitted to Hospital within 30 days following discharge, were this occurs it is likely to represent a difficult patient experience and add significantly to the resource burden of the Trust if this occurs with greater than expected frequency.

• What IQVIA Ltd. and IQVIA Technology Services Ltd. did:

IQVIA utilised Trust supplied data assets and National Hospital Episode Statistics (HES data), to complete a deep dive review of the Stroke service and Hospital Readmissions on behalf of the Trust. The analysis examined the stroke service and readmissions following stroke and readmissions in a wider Trust context across the service portfolio of the Hospital.

For stroke diagnosis code defined patients, based on the volume of admissions to the analysed Units, IQVIA used these defined Units as a basis for comparison of multiple performance measures within a detailed HES data analysis, also utilising Trust supplied data to examine and review clinical coding information at a benchmarked National, and local level. Additional benchmarking tools utilising National data enabled detailed review of stroke services performance indicators and detailed analysis of readmissions.

Observed percentage readmission rates at the Trust were high relative to peer organisations and National benchmarks, for example, and Trust clinical teams managed 54 readmissions within 30 days of discharge following an acute stroke, with cerebral infarction identified as the most common recorded reason for patient readmission.

The avoidance of readmissions even where the readmission results in a zero length of stay, will still impact on Trust resources (particularly A&E), and add to the pressures experienced across the emergency department. The results of the project should help the Trust to focus on key areas for improvement.

Benefits to Patient Care:

The project focused on investigating a national and local view of stroke related activity for designated HASU's and the impact of variation in key measures. These insights were distilled into a highly focused report to initiate Trust service improvements. Locally future patients would benefit from the Trust implementing;

A comprehensive performance framework to monitor upstream patient flow to;

• Assess likely future demand for stroke services across a wider geography

• Liaise with and support primary care management of stroke “at risk” patients in the system

The Trust utilising the ‘stroke service’ as a “pilot” service for a review of discharge processes that could be rolled out across all Trust specialties following initial implementation and post-implementation review by Trust service teams.

IQVIA is a business comprising of several legal entities which provide information, technology and services to healthcare. IQVIA Ltd. and IQVIA Technology Services Ltd. are two of the legal entities which are part of the IQVIA group. Under this agreement IQVIA Ltd. and IQVIA Technology Services Ltd. are requesting permission to continue to use and receive pseudonymised record-level HES Data and to add Mortality Data.

IQVIA Ltd. and IQVIA Technology Services Ltd. use pseudonymised, monthly refreshed Hospital Episode Statistics Data comprising of Admitted Patient Care, Outpatients and Accident and Emergency datasets to undertake analysis, develop services and provide solutions to providers of Healthcare and life sciences services such as:

• Clinical Commissioning Groups (CCGs)

• Commissioning Support Units (CSU’s)

• Hospital Trusts

• Private secondary care providers

• Mental Health trusts

• Community Provider Trusts

• Pharmacies

• NHS England

• Public Health England

• Sustainability and Transformation Partnerships (STPs)

• NHS Trusts

• Clinical teams

• Health and Wellbeing Boards

• Universities

• Life science industry

• Pharmaceutical companies

• Medical Device companies

• Industry bodies – limited to the Association of the British Pharmaceutical Industry (ABPI), Ethical Medicines Industry Group (EMIG) and the Proprietary Associated of Great Britain (PAGB)

IQVIA Ltd. and IQVIA Technology Services Ltd. are requesting Civil Registration Data linked to HES data in order to derive Summary Hospital Mortality Indicators (SHMI), which is a recognised indicator for mortality in the NHS as part of the Data. This is to support existing work and to develop new analyses about outcomes which will, in turn enable deeper insights into healthcare, for example a better understanding of the impact of variations in healthcare.

IQVIA Ltd. and IQVIA Technology Services Ltd. are requesting to continue to hold back Data for 5 complete data years, to conduct longitudinal disease burden, rare disease and outcome analysis. IQVIA will determine the maximum amount of Data necessary for each project.

The HES Data enables IQVIA Ltd. and IQVIA Technology Services Ltd. to provide services and solutions to its customers which include analysis, interpretation and reports. Those analyses, interpretations and reports assist such customers in supporting the understanding of care pathways, delivering clarity to hospitals on their use of medicines, enabling the development of diagnostic algorithms, enabling patients to be recruited to trials, and supporting healthcare commissioners and providers in achieving exceptional Data quality. These services will enable the development of health economic models that evaluate care delivery in relation to outcomes achieved for the patient and in so doing, help advance and benefit healthcare in a variety of different ways.

IQVIA Ltd. and IQVIA Technology Services Ltd. also utilise these HES Data to provide services to commercial organisations within the life sciences industry such as pharmaceutical, medical device and patient organisations, as well as healthcare charities and industry bodies. These organisations use the outputs and insights provided by IQVIA Ltd. and IQVIA Technology Services Ltd. to improve healthcare and assist the efficiency of the National Health Service. The use of the Data supports the development of innovative solutions and service improvement and helps to track outcomes and provide real-world evidence as required by the NHS, NICE, and NHS England with the aim of improving patient care and support enhanced access to improved services and innovative solutions. In addition, these customers use these outputs for the purposes of providing supporting information required by the NHS for business cases, epidemiological research, pathway analysis, burden of disease analysis, health economic research, predictive analytical modelling, NICE submissions and quality and outcome analysis, the outputs of which are shared directly or indirectly with the NHS to support improvements in patient care.

The Legal basis for processing of personal data relating to patient health is under Article 9(2)(j)of the GDPR - Processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. The data subjects’ interests and fundamental rights are protected through appropriate minimisation of fields; protection of the data in a secure environment and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project.

IQVIA Ltd. and IQVIA Technology Services Ltd are processing the data in line with their goals as part of their legitimate interests. This is covered under the GDPR Article 6(1)(f) - This work is necessary for the purposes of the legitimate interests pursued by the controller except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child.

As set out in the legitimate interest assessment - the data requested is to help achieve the following examples:

Care Pathway Analysis,

Hospital Feedback services,

Benchmarking,

Diagnostic algorithm development studies,

Epidemiology studies,

Health economics and outcomes research studies,

Trust data quality reviews,

Clinical trial analysis.

The use of the data allows IQVIA Ltd. and IQVIA Technology Services Ltd as part of their Legitimate Interests to provide services to improve healthcare for citizen’s and provide support services to healthcare providers to enable them to deliver better healthcare. This includes analysis and interpretation which provide understanding of care pathways, understanding use of medicines, recruiting patients to trials, and supporting healthcare commissioners and providers in achieving data quality, all these examples are with the aim of improving overall healthcare.

IQVIA Ltd. and IQVIA Technology Services Ltd also utilise this Pseudonymised data to provide services to commercial organisations to improve healthcare and assist the efficiency of the National Health Service in the interest of public health. The service supports the development of innovative solutions and service improvement and helps to track outcomes and provide real-world evidence as required by the NHS, NICE, and NHS England with the aim of improving patient care and support enhanced access to improved services and innovative solutions. In addition, IQVIA Ltd. and IQVIA Technology Services Ltd have found no evidence that the use of this data negatively impacts the fundamental rights and freedoms of the data subjects. Individuals have got the right to opt out of the use of this data.

All data passed on is small number suppressed as per HES Analytics guide.

IQVIA Ltd. and IQVIA Technology Services Ltd. will use the Data to perform two types of services (together these services are known as the “Permitted Services"):

1. Data Visualisation and Benchmarking (the "Service 1" services). This is a suite of software tools into which the relevant Data is loaded, which enables users to view metrics using tables, maps and charts. All outputs are aggregated with small numbers suppressed in line with the HES Analysis Guide.

Specific examples of these Service 1 services include:

i) Care Pathway Analysis

ii) Hospital Feedback services

iii) Visualise Healthcare Data, Healthcare Optimisation Benchmarking

Service 1 is managed via one or more appropriate software tools which are controlled and auditable. These software tools are used to display Data, with Data aggregated in line with the HES analysis guide. Any such software tool will allow users to perform analyses on aggregated Data and data from other sources and then view graphs and tables. Anyone using these software tools must enter into a contract the terms of which provide that they only use the Data for the purposes covered in this Data Sharing Agreement.

2) Advanced Statistical Analysis (the “Service 2” services) is bespoke analysis for external organisations on a project by project basis.

Typical examples of the Permitted Services are described below:

Service 1: Data visualisation and benchmarking:

i) Care Pathway Analysis (CPA). Presents users with simple views of aggregated care pathways. This allows investigation of the causes of variation in patient pathways and the subsequent impact on service delivery with the aim to improve healthcare provision.

ii) Hospital Feedback Services (HFS). A dashboard assisting chief pharmacists in the optimisation of their use of medicines. It will allow them to monitor their own performance against internal targets and benchmark against similar hospitals. NHS Trusts are granted access to HFS in exchange for continued supply of non-identifiable prescription Data to IQVIA and agreement that IQVIA can use the Data for more further research.

iii) Visualise Healthcare Data (VHD). A suite of software tools / reports / dashboards, that allows users to perform queries on aggregated HES Data and data from other sources which they can then view as graphs and tables. The Data can be used to enable a Trust to compare its performance to other Trusts against a range of clinical indicators and identify where it could make improvements in the delivery of care to patients. A Sustainability and Transformation Partnership (STP) or Trust may also wish to use the Data to analyse at a regional and local level how best how to manage its resources in response to changes in demand and understand the scope of the changes it would need to make to improve patient care.

Service 2: Advanced Statistical Analysis bespoke analysis on a project by project basis, such as:

i, Diagnostic algorithm development studies - Machine learning and artificial intelligence to develop algorithms to diagnose patients,

ii, Epidemiology studies - The study and analysis of the distribution patterns and determinants of health and disease conditions in defined populations,

iii, Health economics and outcomes research studies - The study of the value of treatments and the health benefits they deliver to enable doctors to make decisions about the best treatment pathway for patients,

iv, Trust data quality reviews - Review of a Trust’s coding data quality against recognised NHS Standards. Data quality reviews generate insights for Hospital Trusts and help improve the consistency of clinical coding. Resulting benchmarking insights facilitate data quality improvements across NHS Trusts.

v, Clinical trial analysis – advanced analytics techniques like machine learning and artificial intelligence may be utilised for predictive algorithm development to identify undiagnosed patients and patients at-risk of disease progression for clinical research enrolment (clinical trials, late phase observational studies) and for healthcare management support that can include disease screening, treatment suitability, treatment response and adherence.

Service 2 may utilise machine learning and artificial intelligence approaches for predictive algorithm development.

Every research study (ie i, ii, iii, iv & v listed above) provided via Service 2 goes to the IQVIA Independent Scientific Advisory Committee (ISEAC) for approval. More details about ISEAC appear in the next section.

The number of organisations to which IQVIA Ltd. and IQVIA Technology Services Ltd. provides products and services changes regularly. Under the 2018/2019 DSA, the data controllers have worked on in excess of 30 projects using this HES Data. Of these projects, approximately half were for repeat customers (i.e. who had purchased at least one other software tool or project from IQVIA within that period).

All outputs of the Data are aggregated with small numbers suppressed in line with the HES analysis guide. the Data Controllers understands the importance of data minimisation and minimises the Data used on a study by study basis.

The insights and analysis may be at national level or provided at a lower level of detail if required (with the suppression rules of NHS Digital applied to the output). IQVIA Ltd. and IQVIA Technology Services Ltd. require national and historical HES Data for the following reasons:

1. IQVIA Ltd. and IQVIA Technology Services Ltd. require national Data to enable the end users of IQVIA software tools to benchmark against organisations in their local area or with similar demographic characteristics. IQVIA Ltd. and IQVIA Technology Services Ltd. also require national Data to inform economic analyses for inclusion in submissions to NICE, which makes decisions at a national level.

2. IQVIA Ltd. and IQVIA Technology Services Ltd. require national Data for Hospital Feedback Service which is for all chief pharmacists in all NHS Trusts.

3. Historic Data is required to support Advanced Statistical Analysis projects, as historical Data allows robust analysis of trends over time.

IQVIA Ltd. and IQVIA Technology Services Ltd. undertake numerous ongoing projects using HES on a yearly basis; approximately 30 distinct projects using such Data were completed in 2018/19. The outputs are varied and in different formats, ranging from dashboards, reports, charts, and models to analysis, research papers and publications. These outputs are intended to achieve benefits to healthcare, including changes in patient care, reduction in costs, uptake and monitoring of policy.

Examples of outputs expected from projects for each of the services are given below:

SERVICE 1: Data visualisation and benchmarking (all Data used in Service 1 is aggregated, small number suppressed in line with the HES analysis guidelines):

Care Pathway Analysis (CPA): CPA is a service either deployed directly to users or used to support consulting projects. In the former case, users are given role-based access to a software tool which will allow them to analyse images of aggregated pathways. In the latter case, outputs will be presentations and reports containing pathway images as well as IQVIA recommendations.

Hospital Feedback Services (HFS): IQVIA has employed a chief pharmacist to provide feedback to hospital pharmacists and currently has approximately 120 Trusts signed up to receive Feedback reports; IQVIA seeks to expand further by engaging with more Trusts by promoting the reports available through networking, events and newsletters.

An example of the information IQVIA supply back into the Trusts is a report on the use of antibiotics by Defined Daily Dose per 1000 admissions (using admission Data from HES for the same month the year before) to show seasonal variation. This report is supplied to the Regional Medicines Optimisation Committees, and Trust Chief Pharmacists can benchmark their own trust against a peer benchmark group of trusts.

Visualise Healthcare Data (VHD): Users are given role-based access to the software tools which allow users to produce graphical and tabular estimates of burden of disease, cost of care, common comorbidities and similar analyses. These analyses may be stratified by diagnosis, organisation and other similar parameters.

VHD includes Cohort Builder reporting, which includes stratification by disease and therapy counts (patients and events), gender, age grouping, events over time and geographical based counts (if available) in line with the current purpose of this DSA.

Other VHD software tools offer nuances of these stratifications including event (diagnosis or therapy types) based breakdowns of medical event counts, user definable age ranges, recruitment models over time with user definable variables, and various visualisations to describe treatment patterns or disease progression using aggregated small number suppressed Data only.

Healthcare optimization Benchmarking:

Provides benchmarking capabilities enabling peer to peer and national comparisons across a range of clinical, financial and operational measures.

SERVICE 2: Advanced Statistical Analysis:

The Data outputs in advanced statistical analysis are always aggregated and small number suppressed in line with the HES Analysis Guide. These outputs are produced to meet different objectives and delivered in different ways.

A health economic analysis may require analysis of the Data to estimate the cost of managing a given condition then used as an input in an economic model for a NICE submission. Developing a diagnostic algorithm will result in the production of a formula which may be presented to clinicians in an Excel based calculator with an explanatory report or presentation. For the case of identification of undiagnosed and/or at-risk patients, clinical trials analysis, predictive models will be developed to determine eligibility for a clinical intervention as part of clinical research participation or healthcare management. The reports that will be generated will inform clinical trial / observational study design and planning.

Data quality reviews generate actionable insights for Hospital Trusts and support the improvement and consistency of clinical coding. Good data quality is extremely important to accurate benchmarking and performance analysis. Benchmarking these insights will facilitate data quality improvements across NHS Trusts. Organisations can then review and refine their service delivery to support patient outcomes in line with national and local quality indicators.

Data will be used to determine eligibility for taking part in clinical research. The reports that will be generated will inform clinical trial / observational study design and planning.

Many of the outputs of advanced statistical analysis are reported in journal articles or conference presentations.

MORTALITY DATA:

When completing any analysis in a healthcare or life science project to generate insights and learning, it is important to ensure that all relevant factors that influence a patient’s health and well-being are considered. For example, when a patient has passed away, it is important to understand all the clinical and demographic circumstances surrounding that loss of life to ensure that all that can be learned is uncovered from any retrospective analysis of the Data. A comprehensive understanding of the contributing factors in that loss of life is critical in understanding whether the life lost was avoidable or whether the services delivered to such patient could have been provided in a more effective way.

Analysis of Mortality Data would provide a different perspective enabling IQVIA to better understand observed patterns in mortality with the aim of improving outcomes. This perspective of the data would enable the identification of patterns within service delivery linked to mortality to facilitate investigation and benchmarking of links between service delivery and death outcomes.

An example of using the Mortality Data is that it will allow IQVIA to implement SHMI calculations in its benchmarking solution, allowing Trusts to view a SHMI for custom patient groups in addition to the hospital and site wide-indicators available via NHS Digital. By allowing Trusts to look at SHMI for specialties, or large patient cohorts, the NHS organisations e will have a greater visibility of SHMI statistics and how these look at the specialty level. This greater visibility of SHMI information will allow NHS Trusts to focus on areas where deaths are higher than expected and give them a tool to assist in identifying areas of care worthy of further investigation, as part of their efforts to improve healthcare and patient safety in their organisations.

Examples of benefits from projects:

WEST MIDLANDS CCGs:

IQVIA worked with the Associate Director of Commissioning for three Staffordshire CCG’s and completed detailed pathway analytics in relation to Upper and Lower Gastrointestinal scope procedures, delivered by multiple West Midlands Providers from August 2016 to December 2016 (with a further concluding Client follow-up in February 2017).

• Why was this issue important?

Three Staffordshire CCGs were required to achieve a reduction in planned care expenditure without impacting on overall service quality. The CCGs had contracts with eight acute Providers and direct comparison of pathway performance was difficult with the CCGs’ existing tools and intelligence. Diagnostic scopes within the gastro-enterology specialty were the CCGs' focus area.

• What IQVIA Ltd. and IQVIA Technology Services Ltd. did:

IQVIA utilised National HES Data assets in combination with care pathway technology to identify gastro-enterology pathways where unwarranted variation could be reduced. The providers utilised to meet current demand for Gastroenterology services were highlighted, with variation in pathway performance observed for; average length of stay, average number of patient interventions per pathway and average cost per pathway were all examined.

• Benefits to Patient Care:

The project provided evidence-based insight from the analysis of diagnostic endoscopic gastrointestinal procedures. The CCGs were provided with a clear understanding of existing pathway performance, and an identification of where patient flow was an issue and where to focus service improvement effort.

The completed analysis provided the CCGs with a clear identification of terms for a revised contract for service that could be routinely monitored and managed through the ongoing application of pathway technology to National Data, yielding potential savings of c.£400K per annum.

EAST MIDLANDS MUSCULOSKELETAL SERVICES:

IQVIA worked with the Interim Chief Executive of Cambridge & Peterborough CCG and completed detailed pathway analytics in relation to Hip, Knee & Arthroscopy procedures, delivered by multiple East of England Providers from November 2015 to May 2016

• Why was this issue important?

The CCG wanted to compare knee replacement pathways across the region’s acute providers to ensure the consistent application of recognised best practice. The CCG needed to achieve considerable improvement in financial and clinical performance against an agreed regional benchmark within orthopaedic planned surgeries. The variation across the existing providers of MSK services was a cause for local concern.

• What IQVIA Ltd. and IQVIA Technology Services Ltd. did:

By utilising National HES Data assets in combination with care pathway technology, IQVIA identified all planned knee replacement pathways in order to establish unwarranted variation could be reduced. All knee replacement procedures were analysed for the four acute hospitals that were providing orthopaedic services under contract to the CCG.

• Benefits to Patient Care:

Analysis of National activity to examine variation in pathways identified potential savings worth c.£500K to the CCG, with the results allowing the CCG to establish new service contract benchmarks for optimal patient treatment. Overall, this would reduce the variation in treatment pathways across providers and facilitate improved elective throughput across the CCG and /or reduce the demand for elective bed capacity.

SOUTH COAST HOSPITAL - BENCHMARKING FOR PERFORMANCE IMPROVEMENT:

• Why was this issue important?

The Hospital was looking for a solution to compare the Trust performance with a comprehensive set of performance indicators. This required access to national Data that in turn could be utilised to generate a broad range of performance measures either captured within the Data or derived from the Data. A solution was needed that worked for the Trust Board and provided Board level visualisation of its performance relative to its peers. The IQVIA solution provided the Trust Board with a depth of information and insights that has enabled the Trust to assess performance across several key performance indicators. This has helped the management team of the Trust engage more closely with the Medical Director, Clinicians, and Operational staff.

• What IIQVIA Ltd. and IQVIA Technology Services Ltd. did:

The deployed IQVIA solution utilises national Data to deliver the benchmarking capabilities required by the Board, presenting measures (charts and tables) in line with the HES Data Analysis Guide to ensure that the visualisations were compliant with the guidance whilst also meeting the needs of the Trust. The solution has enabled the Trust to have a clear understanding of who its patients are, and ‘end to end pathway reviews’, bringing together primary and secondary care, commissioners, and public health. The detail of the insights provided by the solution will help to ensure that the cost improvement work streams to be delivered within the Trust will improve the ability of the Trust to deliver service improvements and enhance the care available to all our patients.

• Benefits to Patient Care:

Working with the solution, the Trust identified 41 work streams, with 12 of these now in delivery phase. It is now routinely used for all business cases, responses to tender bids, service re-design, contract negotiations with commissioners, and annual business planning. The solution has become the ‘go to’ tool within the Trust, to aid in the delivery of the Trust’s Financial Recovery Plan, with a current full year impact of £10m.

This Amendment is specifically to address the following change;

IQVIA Ltd has been added as a joint Data Controller as IQVIA are simplifying the number of trading legal entities it has in the UK by transferring the business and assets from IQVIA World Publications Ltd and IQVIA Solutions UK Limited into IQVIA Ltd.

The following details set out the purposes already approved by NHS Digital.

IQVIA is a business comprised of a number of legal entities which provide technology and services to healthcare.

A new software platform called E360 is being used. All data seen by end users is in an aggregated fashion, and NO row level access would be available. Small numbers are suppressed and are compliant with the HES Analysis Guide. There is no new purpose for which the E330 platform will be used its simple replacing the old system used in the previous agreement.

IQVIA will use the HES data to perform two types of service:

1. Data visualisation and benchmarking tools(the "Service 1" services) which includes:

i) Care Pathway Analyser (formerly visualise treatment pathways)

ii) Hospital Feedback services

iii) Visualise Healthcare Data, E360™ Platform and Healthcare Optimisation Benchmarking

2) Advanced Statistical Analysis (formerly referred to as structured disease analysis)

(together, the items listed above are referred to as “Permitted Services”)

1) Key examples of the data visualisation and benchmarking tools are described below:

i) Care Pathway Analyser (CPA). Presents users with simple views of aggregated care pathways. This allows investigation of the causes of variation in patient pathways and the subsequent impact on service delivery.

ii) Hospital Feedback Services (HFS). A dashboard allowing chief pharmacists to optimise their use of medicines. It will also allow them to monitor their own performance against internal targets and benchmark against similar hospitals. This service is still in development. NHS Trusts are granted access to HFS in exchange for continued supply to non-identifiable prescription data and agreement that IQVIA can use the data for more further research.

iii) Visualise Healthcare Data (VHD). A suite of tools/reports,, including Healthcare Optimisation Benchmarking (HOB) that allows users to perform queries on aggregated HES data and data from other sources then view graphs and tables. E360™ A software platform for delivering Real-World Insights from large longitudinal healthcare data sources. The platform allows descriptive analysis of the data.

2) Advanced Statistical Analysis includes: diagnostic algorithm development, epidemiology, health economics and outcomes research studies.

Services will only be provided to the following categories of types of organisation:

- Providers of healthcare services including but not limited to:

• Clinical Commissioning Groups

• Commissioning Support Units (CSU’s)

• Hospital Trusts

• Private secondary care providers

• Mental Health trusts

• Community Provider Trusts

• Pharmacies

• NHS England

• Public Health England

• Sustainability and Transformation Partnerships (STPs)

• Health and Wellbeing Boards

* Universities

* Life science industry

• Pharmaceutical companies

• Medical Device companies

• Industry bodies – limited to the Association of the British Pharmaceutical Industry (ABPI), Ethical Medicines Industry Group (EMIG) and the Proprietary Associated of Great Britain (PAGB)

Third parties will only see aggregated and small number suppressed data.

The number of organisations to whom IQVIA provide products and services changes regularly. In the last twelve months IQVIA have worked on in excess of 30 Advanced Statistical Analysis projects and Data Visualisation and Benchmarking services using HES data held under this DSA. Of these projects, approximately half were for repeat customers (who had purchased at least one other tool or project from IQVIA within that period). During the coming twelve months, IQVIA intends to extend the Benchmarking services to enable in excess of 90 NHS Trusts to access aggregated data to allow them to compare performance against their peers across a number of clinical and operational key performance indicators in order to identify best practice in the delivery of patient care.

IQVIA understands the importance of data minimisation and outline IQVIA's requirement for national, timely HES data in the following paragraphs.

IQVIA requires national data to enable the end users of IQVIA tools to benchmark against organisations in their local area or with similar demographic characteristics. IQVIA also requires national data to inform economic analyses for inclusion in submissions to NICE, which makes decisions at a national level. HFS is intended for all chief pharmacists in NHS Trusts.

The requirement for timely data is because the commissioners and providers to whom IQVIA provide IQVIA ’s tools need to make decisions based on the most up-to-date information. IQVIA won an open tender to perform a medicines optimisation study for a group of cancer treatment providers. More detail on this project is given in later sections.

Historic data is required to support Advanced Statistical Analysis projects, as historical data allows robust analysis of trends over time.

For clarity services covered within this application only produce two types of output:

• Dashboards

• Aggregated tables

In both cases outputs are aggregated and small numbers suppressed in line with the HES Analysis Guide. Details for each of the services are given below.

Visualise Healthcare Data (VHD):

VHD is an internet browser based application, an iPad application or a bespoke report. Users are given role based access to the applications. The applications allow users to produce graphical and tabular estimates of burden of disease, cost of care, common comorbidities and similar analyses. These analyses may be stratified by diagnosis, organisation and other similar parameters. The HOB application is based on VHD but also provides benchmarking capabilities enabling peer to peer and national comparisons across a range of clinical, financial and operational measures

Care Pathway Analyser (CPA):

CPA is currently an internet browser based application and other delivery methods are in development. CPA will either be deployed directly to users or used to support consulting projects. In the former users are given role based access to the application which will allow them to analyse images of aggregated pathways. In the latter, outputs will be presentations and reports containing pathway images as well as IQVIA recommendations.

E360:

Several outputs within the tool are available, including:

Cohort Builder reporting, which includes stratification by disease and therapy counts (Patient and event), gender, age grouping, events over time and geographical based counts (if available) in line with the current purpose of this agreement.

Other applications offer nuances of these stratifications including event (diagnosis or therapy types) based breakdowns of medical event counts, user definable age ranges, recruitment models over time with user definable variables, and various visualisations to describe treatment patterns or disease progression using aggregated small number suppressed data only.

Hospital Feedback Services (HFS):

Since launch IQVIA has employed a chief pharmacist to provide feedback to hospital pharmacists and IQVIA currently have approximately 75 trusts signed up to receive Feedback via the Medicines Optimisation Dashboard and we continue to engage with more Trusts.

An example of the information IQVIA supply back into the NHS is a report on the use of antibiotics by Defined Daily Dose per 1000 admissions (using admission data from HES for the same month the year before – to show seasonal variation. This report is supplied to the Regional Medicines Optimisation Committees and Trust Chief Pharmacists can benchmark their own trust against a peer benchmark group of trusts.

Advanced Statistical Analysis

The data included in advanced statistical analysis are always aggregated and small number suppressed in line with the HES Analysis Guide. These outputs are produced to meet different objectives and delivered in different ways. A health economic analysis may require analysis of the data to estimate the cost of managing a given condition then used as an input in an economic model for a NICE submission. Developing a diagnostic algorithm will result in the production of a formula which may be presented to clinicians in an Excel based calculator with an explanatory report or presentation. Many of the outputs of advanced statistical analysis are reported in journal articles or conference presentations

Examples of benefits from projects

Cancer Vanguard – Unwarranted Variation in metastatic Colorectal Cancer

HES data was used to identify unwarranted variation in treatment pathways for patients. The aim was to promote the choice of cancer medications based on evidence and enhance the understanding of the patient’s treatment experience so that service optimisation and re-design would be patient centric.

The project represented a living embodiment of the Digital objective of the Life Sciences Industrial Strategy: “Supporting collaboration on real world evidence, enabling innovators and the NHS to research modern technologies.” It enabled a clear baseline to be set of how patients are treated for and the ability to forecast the impact market and treatment dynamics will have on NHS finances.

Key Actionable Insights (whole project not just HES component)

•Deviation from NICE Therapy Guidance: Across the peer group a 7-fold difference in the proportional use of Biological therapy vs Chemo therapy

•Improvements in the consistency of care could be achieved at one Cancer Vanguard Trust by focusing on 4 key variables out of 200

•Baseline quality of care responses remained stable throughout the project. However, the insights highlighted a worsening of the information shared by doctors about the illness, a worsening in the information doctors shared about the treatment, and a decrease in the quality of the environment, including cleanliness and calmness.

“The formation of the Cancer Vanguard gave us an unprecedented opportunity to explore new ways of working with the pharmaceutical industry. The aim has always been to ensure the best use of cancer medicines in a way that improves patient experience. Our work with IQVIA is an example of how the health service and industry can join forces to deliver sustainable improvements in cancer services.’’ Professor Rob Duncombe Director of Pharmacy. The Christie NHS Foundation Trust

Multi-Hospital Site DVT Treatment Variation Project

Since introduction, novel oral anticoagulants (NOACS) have not experienced the uptake anticipated following their NICE recommendation. By utilising these new compounds, the NHS can alter the way Deep Vein Thrombosis (DVT) treatment pathways are delivered.

The goals of this partnership project were:

•Understand how DVT is currently treated

•Compare how individual Trusts treat patients with DVT Nationally and within Benchmark Trusts

•Quantify the potential financial implications associated with a change in DVT treatment pathway

•Outline potential change tactics and key messages that could be aligned to a shift in treatment approach

The National analysis presented key observations associated with the current clinical management of DVT. DVT hospital treatment is resource intensive placing scarce hospital resources under further pressure with variation in current care pathways. Findings uncovered from the study identified key drivers that all impact on the financial sustainability of local DVT services. The choice of clinical pathway will impact on Trust financial performance, working with key stakeholders to implement alternative pathways can mitigate financial risk. A key outcome of the work presented to representatives from 90 UK Trusts was the need to understand how the clinical strategy adopted by a Trust can impact the level of financial risk the Hospital is exposed to.

Greater Manchester Liver Disease

Working with NHS, academic and professional bodies from the Greater Manchester region IQVIA presented an overview of how liver disease, was being managed across the region. This overview of liver disease treatment pathways was delivered utilising National HES data with National Care Pathway Analytics technology deployed over the data. This provided IQVIA with treatment pathway visualisation at Clinical Commissioning Group level showing aggregated treatment pathway volumes, the cost associated with these pathways, the typical length of stay and the average number of treatment events per pathway. Isolating key performance indicators by each of the 12 Greater Manchester CCG’s highlighted the variation in both clinical management of the disease area, and the cost and capacity implications of that variation.

A key outcome of the work will be the utilisation of the analysis to improve and standardise the management of patients’ within this disease cohort.

Salford Royal Hospital – Unwarranted treatment pathway variation

IQVIA presented the National Care Pathway Analytics solution (based on care pathway technology applied to HES data assets) solution to Salford Royal NHSFT. When demonstrating the NCPA solution to the Trust, the Trust commented that;

"NCPA provided an insight into the performance of Salford Royal NHSFT and allowed them to benchmark against other Trusts both nationally and within the Greater Manchester region and identified that there was an issue. In order to investigate further and allow for real change, deeper analysis on local Trust data, taking in additional datasets not available in HES was required. However without the initial NCPA analysis, these issues may have gone unnoticed."

The Trust envisages that a local developed and configured Care Pathway Analysis solution would be most effectively deployed within the Trust’s Quality Improvement Team. Further to presenting CPA to the six Associate Directors of Quality Improvement within the Northern Care Alliance NHS Group, the feedback received from the Trust included;

The potential of the solution for the future was exciting. If you could do for a disease pathway level (e.g. stroke) what you can do now for cost it would be amazing for patient care. In the stroke example though if we could pull all of the clinical best practice and understand our variation in an almost real time basis it would be great for patient care for example

- Arrival in ED

- Time to scan

- Weighing of patient

- Time to aspirin

- Hours of OT/Physio

- Swallow assessment

As it is now - "We liked the way that you could map patients into detail and then back up again. When all of our available data sources are into the software we would be able to quantify days where patients are in the hospitals and they are not having specific interventions which contribute to making them better or rehabilitation.”

Because of the utilisation of National HES data delivered to the Trust in a unique and creative way has led to the development and delivery of a detailed local project that can enable the Trust to support the identification and reduction of unwarranted variation in patient treatment pathways.

Outcome – Delivered to Client, Local deployment of Care Pathway Analytics product that will enable and support the delivery of a reduction in clinical variation, improving Length of Stay (LOS), increase profitability and deliver improved operational efficiency

The Christie NHS Foundation Trust - Breast Cancer Pathway Joint Working Partnership Project

This project developed partnership working, collaborative sharing of insights and expertise between the NHS, Novartis and IQVIA to support the NHS to optimise the treatment of breast cancer within Greater Manchester and consequently contribute to overall improvement of patient care within the Greater Manchester cancer health system.

Jointly working with the Breast Cancer clinical team at The Christie, and led by Professor Andrew Wardley (Breast Cancer Specialist Oncology Consultant), this project investigated the hypothesis that breast cancer care in Greater Manchester (GM) is adversely affected by inequities of access to treatment that could be ameliorated through the optimisation of treatment pathways between the referring centres and The Christie.

In this project, IQVIA led the elaboration of an evidenced-based approach to facilitate service re-design through the analysis of real world data assets such as HES data, clinical cancer specific datasets (CAS and SACT) and patient experience data. Special emphasis was made to ensure that a mutually beneficial partnership between all stakeholders was created from the outset. In doing so, a quantified case for change was created to support future clinical transformation, drawing insight from data relating to clinical activity, cost of care and patient treatment experience.

Quantifying the secondary care system burden of pre and post-Influenza hospitalisation

This scientific study - used HES data allied to novel methodological approaches to investigate the healthcare burden and resource use associated with influenza hospitalisations for patients with diabetes, cardiovascular and respiratory diseases, in order to highlight the need for further optimisation of vaccination programmes in the NHS for those patients most at risk from complications relating to their influenza.

The findings of this study, outlined below, have been accepted for poster presentation in ISPOR Europe (Barcelona 2018), and nominated in award categories for such congress:

•Total secondary costs per patient were significantly higher post-influenza diagnosis in all clinical risk groups (CRGs) under investigation. Influenza infection also significantly increased burden of care in terms of bed days, readmission rates, and total care events per patient.

•Nationally, over a five year period, influenza infections may have incurred an additional system burden of £510 million for the care of patients in CRGs (excluding primary care, indirect, and societal costs), with CHD patients producing the highest burden. Should the recent trend of increasing hospitalisations continue, this reported cost could increase further.

This study provided the evidence to further optimise and prioritise vaccination programmes to reduce the secondary care burden of influenza and its complications, and as a primary intervention to help alleviate winter pressures.

IQVIA is a business comprised of a number of legal entities which provide technology and services to healthcare. This agreement is a request for the renewal to the agreement for pseudonymised record-level HES data to be controlled by two legal entities: IQVIA Solutions UK Limited and IQVIA Technology Services Ltd.

Hereafter, these two entities will be referred to collectively as IQVIA

In addition an amendment which consists of

Remove the Processing/Storage address Ardentia House, Staffordshire Technology park, Stafford, ST18 0LQ as no longer being used.

In addition a new software platform called E360 is being used. All data seen by end users is in an aggregated fashion, and NO row level access would be available. Small numbers are suppressed and are compliant with the HES Analysis Guide. There is no new purpose for which the E330 platform will be used its simple replacing the old system used in the previous agreement.

IQVIA will use the HES data to perform two types of service:

1. Data visualisation and benchmarking tools(the "Service 1" services) which includes:

i) Care Pathway Analyser (formerly visualise treatment pathways)

ii) Hospital Feedback services

iii) Visualise Healthcare Data, E360™ Platform and Healthcare Optimisation Benchmarking

2) Advanced Statistical Analysis (formerly referred to as structured disease analysis)

(together, the items listed above are referred to as “Permitted Services”)

1) Key examples of the data visualisation and benchmarking tools are described below:

i) Care Pathway Analyser (CPA). Presents users with simple views of aggregated care pathways. This allows investigation of the causes of variation in patient pathways and the subsequent impact on service delivery.

ii) Hospital Feedback Services (HFS). A dashboard allowing chief pharmacists to optimise their use of medicines. It will also allow them to monitor their own performance against internal targets and benchmark against similar hospitals. This service is still in development. NHS Trusts are granted access to HFS in exchange for continued supply to non-identifiable prescription data and agreement that IQVIA can use the data for more further research.

iii) Visualise Healthcare Data (VHD). A suite of tools/reports,, including Healthcare Optimisation Benchmarking (HOB) that allows users to perform queries on aggregated HES data and data from other sources then view graphs and tables. E360™ A software platform for delivering Real-World Insights from large longitudinal healthcare data sources. The platform allows descriptive analysis of the data.

2) Advanced Statistical Analysis includes: diagnostic algorithm development, epidemiology, health economics and outcomes research studies.

Services will only be provided to the following categories of types of organisation:

- Providers of healthcare services including but not limited to:

• Clinical Commissioning Groups

• Commissioning Support Units (CSU’s)

• Hospital Trusts

• Private secondary care providers

• Mental Health trusts

• Community Provider Trusts

• Pharmacies

• NHS England

• Public Health England

• Sustainability and Transformation Partnerships (STPs)

• Health and Wellbeing Boards

* Universities

* Life science industry

• Pharmaceutical companies

• Medical Device companies

• Industry bodies – limited to the Association of the British Pharmaceutical Industry (ABPI), Ethical Medicines Industry Group (EMIG) and the Proprietary Associated of Great Britain (PAGB)

Third parties will only see aggregated and small number suppressed data.

The number of organisations to whom IQVIA provide products and services changes regularly. In the last twelve months IQVIA have worked on in excess of 30 Advanced Statistical Analysis projects and Data Visualisation and Benchmarking services using HES data held under this DSA. Of these projects, approximately half were for repeat customers (who had purchased at least one other tool or project from IQVIA within that period). During the coming twelve months, IQVIA intends to extend the Benchmarking services to enable in excess of 90 NHS Trusts to access aggregated data to allow them to compare performance against their peers across a number of clinical and operational key performance indicators in order to identify best practice in the delivery of patient care.

IQVIA understands the importance of data minimisation and outline IQVIA's requirement for national, timely HES data in the following paragraphs.

IQVIA requires national data to enable the end users of IQVIA tools to benchmark against organisations in their local area or with similar demographic characteristics. IQVIA also requires national data to inform economic analyses for inclusion in submissions to NICE, which makes decisions at a national level. HFS is intended for all chief pharmacists in NHS Trusts.

The requirement for timely data is because the commissioners and providers to whom IQVIA provide IQVIA ’s tools need to make decisions based on the most up-to-date information. IQVIA won an open tender to perform a medicines optimisation study for a group of cancer treatment providers. More detail on this project is given in later sections.

Historic data is required to support Advanced Statistical Analysis projects, as historical data allows robust analysis of trends over time.

For clarity services covered within this application only produce two types of output:

• Dashboards

• Aggregated tables

In both cases outputs are aggregated and small numbers suppressed in line with the HES Analysis Guide. Details for each of the services are given below.

Visualise Healthcare Data (VHD):

VHD is an internet browser based application, an iPad application or a bespoke report. Users are given role based access to the applications. The applications allow users to produce graphical and tabular estimates of burden of disease, cost of care, common comorbidities and similar analyses. These analyses may be stratified by diagnosis, organisation and other similar parameters. The HOB application is based on VHD but also provides benchmarking capabilities enabling peer to peer and national comparisons across a range of clinical, financial and operational measures

Care Pathway Analyser (CPA):

CPA is currently an internet browser based application and other delivery methods are in development. CPA will either be deployed directly to users or used to support consulting projects. In the former users are given role based access to the application which will allow them to analyse images of aggregated pathways. In the latter, outputs will be presentations and reports containing pathway images as well as IQVIA recommendations.

E360:

Several outputs within the tool are available, including:

Cohort Builder reporting, which includes stratification by disease and therapy counts (Patient and event), gender, age grouping, events over time and geographical based counts (if available) in line with the current purpose of this agreement.

Other applications offer nuances of these stratifications including event (diagnosis or therapy types) based breakdowns of medical event counts, user definable age ranges, recruitment models over time with user definable variables, and various visualisations to describe treatment patterns or disease progression using aggregated small number suppressed data only.

Hospital Feedback Services (HFS):

Since launch IQVIA has employed a chief pharmacist to provide feedback to hospital pharmacists and IQVIA currently have approximately 75 trusts signed up to receive Feedback via the Medicines Optimisation Dashboard and we continue to engage with more Trusts.

An example of the information IQVIA supply back into the NHS is a report on the use of antibiotics by Defined Daily Dose per 1000 admissions (using admission data from HES for the same month the year before – to show seasonal variation. This report is supplied to the Regional Medicines Optimisation Committees and Trust Chief Pharmacists can benchmark their own trust against a peer benchmark group of trusts.

Advanced Statistical Analysis

The data included in advanced statistical analysis are always aggregated and small number suppressed in line with the HES Analysis Guide. These outputs are produced to meet different objectives and delivered in different ways. A health economic analysis may require analysis of the data to estimate the cost of managing a given condition then used as an input in an economic model for a NICE submission. Developing a diagnostic algorithm will result in the production of a formula which may be presented to clinicians in an Excel based calculator with an explanatory report or presentation. Many of the outputs of advanced statistical analysis are reported in journal articles or conference presentations.

Examples of benefits from projects

Cancer Vanguard – Unwarranted Variation in metastatic Colorectal Cancer

HES data was used to identify unwarranted variation in treatment pathways for patients. The aim was to promote the choice of cancer medications based on evidence and enhance the understanding of the patient’s treatment experience so that service optimisation and re-design would be patient centric.

The project represented a living embodiment of the Digital objective of the Life Sciences Industrial Strategy: “Supporting collaboration on real world evidence, enabling innovators and the NHS to research modern technologies.” It enabled a clear baseline to be set of how patients are treated for and the ability to forecast the impact market and treatment dynamics will have on NHS finances.

Key Actionable Insights (whole project not just HES component)

•Deviation from NICE Therapy Guidance: Across the peer group a 7-fold difference in the proportional use of Biological therapy vs Chemo therapy

•Improvements in the consistency of care could be achieved at one Cancer Vanguard Trust by focusing on 4 key variables out of 200

•Baseline quality of care responses remained stable throughout the project. However, the insights highlighted a worsening of the information shared by doctors about the illness, a worsening in the information doctors shared about the treatment, and a decrease in the quality of the environment, including cleanliness and calmness.

“The formation of the Cancer Vanguard gave us an unprecedented opportunity to explore new ways of working with the pharmaceutical industry. The aim has always been to ensure the best use of cancer medicines in a way that improves patient experience. Our work with IQVIA is an example of how the health service and industry can join forces to deliver sustainable improvements in cancer services.’’ Professor Rob Duncombe Director of Pharmacy. The Christie NHS Foundation Trust

Multi-Hospital Site DVT Treatment Variation Project

Since introduction, novel oral anticoagulants (NOACS) have not experienced the uptake anticipated following their NICE recommendation. By utilising these new compounds, the NHS can alter the way Deep Vein Thrombosis (DVT) treatment pathways are delivered.

The goals of this partnership project were:

•Understand how DVT is currently treated

•Compare how individual Trusts treat patients with DVT Nationally and within Benchmark Trusts

•Quantify the potential financial implications associated with a change in DVT treatment pathway

•Outline potential change tactics and key messages that could be aligned to a shift in treatment approach

The National analysis presented key observations associated with the current clinical management of DVT. DVT hospital treatment is resource intensive placing scarce hospital resources under further pressure with variation in current care pathways. Findings uncovered from the study identified key drivers that all impact on the financial sustainability of local DVT services. The choice of clinical pathway will impact on Trust financial performance, working with key stakeholders to implement alternative pathways can mitigate financial risk. A key outcome of the work presented to representatives from 90 UK Trusts was the need to understand how the clinical strategy adopted by a Trust can impact the level of financial risk the Hospital is exposed to.

Greater Manchester Liver Disease

Working with NHS, academic and professional bodies from the Greater Manchester region IQVIA presented an overview of how liver disease, was being managed across the region. This overview of liver disease treatment pathways was delivered utilising National HES data with National Care Pathway Analytics technology deployed over the data. This provided IQVIA with treatment pathway visualisation at Clinical Commissioning Group level showing aggregated treatment pathway volumes, the cost associated with these pathways, the typical length of stay and the average number of treatment events per pathway. Isolating key performance indicators by each of the 12 Greater Manchester CCG’s highlighted the variation in both clinical management of the disease area, and the cost and capacity implications of that variation.

A key outcome of the work will be the utilisation of the analysis to improve and standardise the management of patients’ within this disease cohort.

Salford Royal Hospital – Unwarranted treatment pathway variation

IQVIA presented the National Care Pathway Analytics solution (based on care pathway technology applied to HES data assets) solution to Salford Royal NHSFT. When demonstrating the NCPA solution to the Trust, the Trust commented that;

"NCPA provided an insight into the performance of Salford Royal NHSFT and allowed them to benchmark against other Trusts both nationally and within the Greater Manchester region and identified that there was an issue. In order to investigate further and allow for real change, deeper analysis on local Trust data, taking in additional datasets not available in HES was required. However without the initial NCPA analysis, these issues may have gone unnoticed."

The Trust envisages that a local developed and configured Care Pathway Analysis solution would be most effectively deployed within the Trust’s Quality Improvement Team. Further to presenting CPA to the six Associate Directors of Quality Improvement within the Northern Care Alliance NHS Group, the feedback received from the Trust included;

The potential of the solution for the future was exciting. If you could do for a disease pathway level (e.g. stroke) what you can do now for cost it would be amazing for patient care. In the stroke example though if we could pull all of the clinical best practice and understand our variation in an almost real time basis it would be great for patient care for example

- Arrival in ED

- Time to scan

- Weighing of patient

- Time to aspirin

- Hours of OT/Physio

- Swallow assessment

As it is now - "We liked the way that you could map patients into detail and then back up again. When all of our available data sources are into the software we would be able to quantify days where patients are in the hospitals and they are not having specific interventions which contribute to making them better or rehabilitation.”

Because of the utilisation of National HES data delivered to the Trust in a unique and creative way has led to the development and delivery of a detailed local project that can enable the Trust to support the identification and reduction of unwarranted variation in patient treatment pathways.

Outcome – Delivered to Client, Local deployment of Care Pathway Analytics product that will enable and support the delivery of a reduction in clinical variation, improving Length of Stay (LOS), increase profitability and deliver improved operational efficiency

The Christie NHS Foundation Trust - Breast Cancer Pathway Joint Working Partnership Project

This project developed partnership working, collaborative sharing of insights and expertise between the NHS, Novartis and IQVIA to support the NHS to optimise the treatment of breast cancer within Greater Manchester and consequently contribute to overall improvement of patient care within the Greater Manchester cancer health system.

Jointly working with the Breast Cancer clinical team at The Christie, and led by Professor Andrew Wardley (Breast Cancer Specialist Oncology Consultant), this project investigated the hypothesis that breast cancer care in Greater Manchester (GM) is adversely affected by inequities of access to treatment that could be ameliorated through the optimisation of treatment pathways between the referring centres and The Christie.

In this project, IQVIA led the elaboration of an evidenced-based approach to facilitate service re-design through the analysis of real world data assets such as HES data, clinical cancer specific datasets (CAS and SACT) and patient experience data. Special emphasis was made to ensure that a mutually beneficial partnership between all stakeholders was created from the outset. In doing so, a quantified case for change was created to support future clinical transformation, drawing insight from data relating to clinical activity, cost of care and patient treatment experience.

Quantifying the secondary care system burden of pre and post-Influenza hospitalisation

This scientific study - used HES data allied to novel methodological approaches to investigate the healthcare burden and resource use associated with influenza hospitalisations for patients with diabetes, cardiovascular and respiratory diseases, in order to highlight the need for further optimisation of vaccination programmes in the NHS for those patients most at risk from complications relating to their influenza.

The findings of this study, outlined below, have been accepted for poster presentation in ISPOR Europe (Barcelona 2018), and nominated in award categories for such congress:

•Total secondary costs per patient were significantly higher post-influenza diagnosis in all clinical risk groups (CRGs) under investigation. Influenza infection also significantly increased burden of care in terms of bed days, readmission rates, and total care events per patient.

•Nationally, over a five year period, influenza infections may have incurred an additional system burden of £510 million for the care of patients in CRGs (excluding primary care, indirect, and societal costs), with CHD patients producing the highest burden. Should the recent trend of increasing hospitalisations continue, this reported cost could increase further.

This study provided the evidence to further optimise and prioritise vaccination programmes to reduce the secondary care burden of influenza and its complications, and as a primary intervention to help alleviate winter pressures.

IQVIA is a business comprised of a number of legal entities which provide technology and services to healthcare. This agreement is a request for the renewal to the agreement for pseudonymised record-level HES data to be controlled by two legal entities: IQVIA Solutions UK Limited and IQVIA Technology Services Ltd.

Hereafter, these two entities will be referred to collectively as IQVIA

In addition an amendment which consists of

Remove the Processing/Storage address Ardentia House, Staffordshire Technology park, Stafford, ST18 0LQ as no longer being used.

In addition a new software platform called E360 is being used. All data seen by end users is in an aggregated fashion, and NO row level access would be available. Small numbers are suppressed and are compliant with the HES Analysis Guide. There is no new purpose for which the E330 platform will be used its simple replacing the old system used in the previous agreement.

IQVIA will use the HES data to perform two types of service:

1. Data visualisation and benchmarking tools(the "Service 1" services) which includes:

i) Care Pathway Analyser (formerly visualise treatment pathways)

ii) Hospital Feedback services

iii) Visualise Healthcare Data, E360™ Platform and Healthcare Optimisation Benchmarking

2) Advanced Statistical Analysis (formerly referred to as structured disease analysis)

(together, the items listed above are referred to as “Permitted Services”)

1) Key examples of the data visualisation and benchmarking tools are described below:

i) Care Pathway Analyser (CPA). Presents users with simple views of aggregated care pathways. This allows investigation of the causes of variation in patient pathways and the subsequent impact on service delivery.

ii) Hospital Feedback Services (HFS). A dashboard allowing chief pharmacists to optimise their use of medicines. It will also allow them to monitor their own performance against internal targets and benchmark against similar hospitals. This service is still in development. NHS Trusts are granted access to HFS in exchange for continued supply to non-identifiable prescription data and agreement that IQVIA can use the data for more further research.

iii) Visualise Healthcare Data (VHD). A suite of tools/reports,, including Healthcare Optimisation Benchmarking (HOB) that allows users to perform queries on aggregated HES data and data from other sources then view graphs and tables. E360™ A software platform for delivering Real-World Insights from large longitudinal healthcare data sources. The platform allows descriptive analysis of the data.

2) Advanced Statistical Analysis includes: diagnostic algorithm development, epidemiology, health economics and outcomes research studies.

Services will only be provided to the following categories of types of organisation:

- Providers of healthcare services including but not limited to:

• Clinical Commissioning Groups

• Commissioning Support Units (CSU’s)

• Hospital Trusts

• Private secondary care providers

• Mental Health trusts

• Community Provider Trusts

• Pharmacies

• NHS England

• Public Health England

• Sustainability and Transformation Partnerships (STPs)

• Health and Wellbeing Boards

* Universities

* Life science industry

• Pharmaceutical companies

• Medical Device companies

• Industry bodies – limited to the Association of the British Pharmaceutical Industry (ABPI), Ethical Medicines Industry Group (EMIG) and the Proprietary Associated of Great Britain (PAGB)

Third parties will only see aggregated and small number suppressed data.

The number of organisations to whom IQVIA provide products and services changes regularly. In the last twelve months IQVIA have worked on in excess of 30 Advanced Statistical Analysis projects and Data Visualisation and Benchmarking services using HES data held under this DSA. Of these projects, approximately half were for repeat customers (who had purchased at least one other tool or project from IQVIA within that period). During the coming twelve months, IQVIA intends to extend the Benchmarking services to enable in excess of 90 NHS Trusts to access aggregated data to allow them to compare performance against their peers across a number of clinical and operational key performance indicators in order to identify best practice in the delivery of patient care.

IQVIA understands the importance of data minimisation and outline IQVIA's requirement for national, timely HES data in the following paragraphs.

IQVIA requires national data to enable the end users of IQVIA tools to benchmark against organisations in their local area or with similar demographic characteristics. IQVIA also requires national data to inform economic analyses for inclusion in submissions to NICE, which makes decisions at a national level. HFS is intended for all chief pharmacists in NHS Trusts.

The requirement for timely data is because the commissioners and providers to whom IQVIA provide IQVIA ’s tools need to make decisions based on the most up-to-date information. IQVIA won an open tender to perform a medicines optimisation study for a group of cancer treatment providers. More detail on this project is given in later sections.

Historic data is required to support Advanced Statistical Analysis projects, as historical data allows robust analysis of trends over time.

For clarity services covered within this application only produce two types of output:

• Dashboards

• Aggregated tables

In both cases outputs are aggregated and small numbers suppressed in line with the HES Analysis Guide. Details for each of the services are given below.

Visualise Healthcare Data (VHD):

VHD is an internet browser based application, an iPad application or a bespoke report. Users are given role based access to the applications. The applications allow users to produce graphical and tabular estimates of burden of disease, cost of care, common comorbidities and similar analyses. These analyses may be stratified by diagnosis, organisation and other similar parameters. The HOB application is based on VHD but also provides benchmarking capabilities enabling peer to peer and national comparisons across a range of clinical, financial and operational measures

Care Pathway Analyser (CPA):

CPA is currently an internet browser based application and other delivery methods are in development. CPA will either be deployed directly to users or used to support consulting projects. In the former users are given role based access to the application which will allow them to analyse images of aggregated pathways. In the latter, outputs will be presentations and reports containing pathway images as well as IQVIA recommendations.

E360:

Several outputs within the tool are available, including:

Cohort Builder reporting, which includes stratification by disease and therapy counts (Patient and event), gender, age grouping, events over time and geographical based counts (if available) in line with the current purpose of this agreement.

Other applications offer nuances of these stratifications including event (diagnosis or therapy types) based breakdowns of medical event counts, user definable age ranges, recruitment models over time with user definable variables, and various visualisations to describe treatment patterns or disease progression using aggregated small number suppressed data only.

Hospital Feedback Services (HFS):

Since launch IQVIA has employed a chief pharmacist to provide feedback to hospital pharmacists and IQVIA currently have approximately 75 trusts signed up to receive Feedback via the Medicines Optimisation Dashboard and we continue to engage with more Trusts.

An example of the information IQVIA supply back into the NHS is a report on the use of antibiotics by Defined Daily Dose per 1000 admissions (using admission data from HES for the same month the year before – to show seasonal variation. This report is supplied to the Regional Medicines Optimisation Committees and Trust Chief Pharmacists can benchmark their own trust against a peer benchmark group of trusts.

Advanced Statistical Analysis

The data included in advanced statistical analysis are always aggregated and small number suppressed in line with the HES Analysis Guide. These outputs are produced to meet different objectives and delivered in different ways. A health economic analysis may require analysis of the data to estimate the cost of managing a given condition then used as an input in an economic model for a NICE submission. Developing a diagnostic algorithm will result in the production of a formula which may be presented to clinicians in an Excel based calculator with an explanatory report or presentation. Many of the outputs of advanced statistical analysis are reported in journal articles or conference presentations.

Examples of benefits from projects

Cancer Vanguard – Unwarranted Variation in metastatic Colorectal Cancer

HES data was used to identify unwarranted variation in treatment pathways for patients. The aim was to promote the choice of cancer medications based on evidence and enhance the understanding of the patient’s treatment experience so that service optimisation and re-design would be patient centric.

The project represented a living embodiment of the Digital objective of the Life Sciences Industrial Strategy: “Supporting collaboration on real world evidence, enabling innovators and the NHS to research modern technologies.” It enabled a clear baseline to be set of how patients are treated for and the ability to forecast the impact market and treatment dynamics will have on NHS finances.

Key Actionable Insights (whole project not just HES component)

•Deviation from NICE Therapy Guidance: Across the peer group a 7-fold difference in the proportional use of Biological therapy vs Chemo therapy

•Improvements in the consistency of care could be achieved at one Cancer Vanguard Trust by focusing on 4 key variables out of 200

•Baseline quality of care responses remained stable throughout the project. However, the insights highlighted a worsening of the information shared by doctors about the illness, a worsening in the information doctors shared about the treatment, and a decrease in the quality of the environment, including cleanliness and calmness.

“The formation of the Cancer Vanguard gave us an unprecedented opportunity to explore new ways of working with the pharmaceutical industry. The aim has always been to ensure the best use of cancer medicines in a way that improves patient experience. Our work with IQVIA is an example of how the health service and industry can join forces to deliver sustainable improvements in cancer services.’’ Professor Rob Duncombe Director of Pharmacy. The Christie NHS Foundation Trust

Multi-Hospital Site DVT Treatment Variation Project

Since introduction, novel oral anticoagulants (NOACS) have not experienced the uptake anticipated following their NICE recommendation. By utilising these new compounds, the NHS can alter the way Deep Vein Thrombosis (DVT) treatment pathways are delivered.

The goals of this partnership project were:

•Understand how DVT is currently treated

•Compare how individual Trusts treat patients with DVT Nationally and within Benchmark Trusts

•Quantify the potential financial implications associated with a change in DVT treatment pathway

•Outline potential change tactics and key messages that could be aligned to a shift in treatment approach

The National analysis presented key observations associated with the current clinical management of DVT. DVT hospital treatment is resource intensive placing scarce hospital resources under further pressure with variation in current care pathways. Findings uncovered from the study identified key drivers that all impact on the financial sustainability of local DVT services. The choice of clinical pathway will impact on Trust financial performance, working with key stakeholders to implement alternative pathways can mitigate financial risk. A key outcome of the work presented to representatives from 90 UK Trusts was the need to understand how the clinical strategy adopted by a Trust can impact the level of financial risk the Hospital is exposed to.

Greater Manchester Liver Disease

Working with NHS, academic and professional bodies from the Greater Manchester region IQVIA presented an overview of how liver disease, was being managed across the region. This overview of liver disease treatment pathways was delivered utilising National HES data with National Care Pathway Analytics technology deployed over the data. This provided IQVIA with treatment pathway visualisation at Clinical Commissioning Group level showing aggregated treatment pathway volumes, the cost associated with these pathways, the typical length of stay and the average number of treatment events per pathway. Isolating key performance indicators by each of the 12 Greater Manchester CCG’s highlighted the variation in both clinical management of the disease area, and the cost and capacity implications of that variation.

A key outcome of the work will be the utilisation of the analysis to improve and standardise the management of patients’ within this disease cohort.

Salford Royal Hospital – Unwarranted treatment pathway variation

IQVIA presented the National Care Pathway Analytics solution (based on care pathway technology applied to HES data assets) solution to Salford Royal NHSFT. When demonstrating the NCPA solution to the Trust, the Trust commented that;

"NCPA provided an insight into the performance of Salford Royal NHSFT and allowed them to benchmark against other Trusts both nationally and within the Greater Manchester region and identified that there was an issue. In order to investigate further and allow for real change, deeper analysis on local Trust data, taking in additional datasets not available in HES was required. However without the initial NCPA analysis, these issues may have gone unnoticed."

The Trust envisages that a local developed and configured Care Pathway Analysis solution would be most effectively deployed within the Trust’s Quality Improvement Team. Further to presenting CPA to the six Associate Directors of Quality Improvement within the Northern Care Alliance NHS Group, the feedback received from the Trust included;

The potential of the solution for the future was exciting. If you could do for a disease pathway level (e.g. stroke) what you can do now for cost it would be amazing for patient care. In the stroke example though if we could pull all of the clinical best practice and understand our variation in an almost real time basis it would be great for patient care for example

- Arrival in ED

- Time to scan

- Weighing of patient

- Time to aspirin

- Hours of OT/Physio

- Swallow assessment

As it is now - "We liked the way that you could map patients into detail and then back up again. When all of our available data sources are into the software we would be able to quantify days where patients are in the hospitals and they are not having specific interventions which contribute to making them better or rehabilitation.”

Because of the utilisation of National HES data delivered to the Trust in a unique and creative way has led to the development and delivery of a detailed local project that can enable the Trust to support the identification and reduction of unwarranted variation in patient treatment pathways.

Outcome – Delivered to Client, Local deployment of Care Pathway Analytics product that will enable and support the delivery of a reduction in clinical variation, improving Length of Stay (LOS), increase profitability and deliver improved operational efficiency

The Christie NHS Foundation Trust - Breast Cancer Pathway Joint Working Partnership Project

This project developed partnership working, collaborative sharing of insights and expertise between the NHS, Novartis and IQVIA to support the NHS to optimise the treatment of breast cancer within Greater Manchester and consequently contribute to overall improvement of patient care within the Greater Manchester cancer health system.

Jointly working with the Breast Cancer clinical team at The Christie, and led by Professor Andrew Wardley (Breast Cancer Specialist Oncology Consultant), this project investigated the hypothesis that breast cancer care in Greater Manchester (GM) is adversely affected by inequities of access to treatment that could be ameliorated through the optimisation of treatment pathways between the referring centres and The Christie.

In this project, IQVIA led the elaboration of an evidenced-based approach to facilitate service re-design through the analysis of real world data assets such as HES data, clinical cancer specific datasets (CAS and SACT) and patient experience data. Special emphasis was made to ensure that a mutually beneficial partnership between all stakeholders was created from the outset. In doing so, a quantified case for change was created to support future clinical transformation, drawing insight from data relating to clinical activity, cost of care and patient treatment experience.

Quantifying the secondary care system burden of pre and post-Influenza hospitalisation

This scientific study - used HES data allied to novel methodological approaches to investigate the healthcare burden and resource use associated with influenza hospitalisations for patients with diabetes, cardiovascular and respiratory diseases, in order to highlight the need for further optimisation of vaccination programmes in the NHS for those patients most at risk from complications relating to their influenza.

The findings of this study, outlined below, have been accepted for poster presentation in ISPOR Europe (Barcelona 2018), and nominated in award categories for such congress:

•Total secondary costs per patient were significantly higher post-influenza diagnosis in all clinical risk groups (CRGs) under investigation. Influenza infection also significantly increased burden of care in terms of bed days, readmission rates, and total care events per patient.

•Nationally, over a five year period, influenza infections may have incurred an additional system burden of £510 million for the care of patients in CRGs (excluding primary care, indirect, and societal costs), with CHD patients producing the highest burden. Should the recent trend of increasing hospitalisations continue, this reported cost could increase further.

This study provided the evidence to further optimise and prioritise vaccination programmes to reduce the secondary care burden of influenza and its complications, and as a primary intervention to help alleviate winter pressures.