Information intermediary specialising to produce outputs for use in health and social care (including the use of 10 years of data for beta-thalassemia study)

Meditrends Ltd require HES Outpatient, HES Admitted Patient Care data and HES linked to Civil Registration data in order to achieve the following:

Purpose 1

Provision of an online portal (Meditrends online), allowing NHS staff and clients to view a range of analytics and epidemiological information in order to:

• Identify areas of clinical need to help inform planning decisions and research programmes.

• Understand local and national epidemiology, and the efficiency of existing clinical pathways and services.

• Model more efficient, integrated (between health and social care) pathways and services.

• Monitor the success of newly implemented pathways and services.

Purpose 2

Meditrends Limited receives requests (as part of projects led by NHS organisations) for suppressed, aggregated, non-sensitive, non-identifiable tabulated data both on an ad-hoc basis and as part of longer term healthcare development projects. These requests may be limited to the provision of aggregated HES data or may require the provision of analysis and interpretation. The analyses Meditrends Limited undertakes are complicated and are required in rapid timeframes to achieve NHS and social care project objectives. In all cases, projects are led by NHS organisations or by other organisations in partnership with or in response to requests for information from NHS organisations or affiliated bodies, including NICE. In addition to the purposes outlined in purpose 1 above, the specific purposes are:

• Providing information about budget impact of new technologies.

• Comparing effectiveness and cost-effectiveness of alternative care pathways.

• Supporting best practice in healthcare delivery.

Meditrends Ltd considers that it is able to rely on legitimate interests, under article 6(1)(f) for its processing of HES data as:

• It has a commercial interest in providing HES data services

• Processing HES data is the only way these services can be provided

• Processing HES data is not used for making decisions on individuals’ health care

• Processing HES data is likely to benefit individuals by providing better access to new health technologies

• The NHS Digital website makes the data transferred to Meditrends transparent. Meditrends provides a clear and comprehensive fair processing notice

Meditrends Ltd agreement with NHS Digital contains permitted uses of HES data which fall under the following category mentioned in Article 9 (2) j:

• “scientific or historical research purposes or statistical purposes” - paragraph 1(j)

• Only pseudonymised data is involved in this dissemination and no fields that are classed as sensitive are included as such there is no risk of potential harm to the public.

Purpose 1:

The requested, episode level data will be grouped and analysed across a range of categories, including geographic (commissioners and providers), clinical (diagnoses and procedures) to provide a range of aggregated epidemiological and operational analytics. Outputs will be presented through a web portal so that users can produce customised reports. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

Purpose 2:

The requested data will be used to answer specific questions from clients which are too complex to be addressed through the Meditrends web portal. These may include the provision of cost-effectiveness analysis of particular types of patient based on co-morbidities or other clinical/demographic factors.

In order to provide the comprehensive analyses described under purpose 1, the data requested includes all available subjects and no filters are applied.

Purpose 1

Meditrends Online aims to improve the ease with which key stakeholders in the commissioning cycle can access and use important health measures.

Meditrends Online is a web delivered system that uses aggregated, suppressed, non-sensitive, non-identifiable HES data to:

• Identify areas of clinical need to help inform planning decisions and research programmes.

• Understand local and national epidemiology, and the efficiency of existing clinical pathways and services.

• Model more efficient, integrated (between health and social care) pathways and services.

• Monitor the success of newly implemented pathways and services.

The current users of Meditrends Online are:

• Public Sector Organisations responsible for the planning, evaluation, commissioning or provision of health and social care including:

• NHS England organisations including: Clinical Commissioning groups, GP practices, Acute Trusts, Area & Regional Teams

• Government & government aligned groups: DH, NHS England, NICE and Academic Health Science Networks (AHSN), NHS England Commissioning Support Units (CSUs)

• Life Science Companies (pharmaceutical, medical technology, and medical biotechnology);

All Life Science Companies are required to be members of the Association of British Pharmaceutical Companies (ABPI), the UK BioIndustry Association or the Association of British Healthcare Industries (ABHI)

Meditrends Online outputs will be used by the ultimate beneficiary to optimise the Commissioning Cycle in the following ways:

• To assess performance against similar organisations and to understand where change could be required to achieve

• Quality Innovation Productivity and Prevention (QIPP) planning.

• To communicate with all stakeholders in explaining the rationale for change and to create engagement with users to understand their needs in the commissioning process.

• To identify areas of best practice in disease management. To use this data to define, monitor and communicate critical indicators of success.

• To forecast future levels of demand for services and configure local resources to meet these needs.

Although the users of Meditrends Online are all of the above groups, the data can only be used for the purposes listed above, with the ultimate beneficiary in all cases being the NHS and Social Care. All users will give an undertaking to this effect, and all applications to become registered users are assessed by the Meditrends Directors against the following criteria:

• The applicant must belong to one of the customer groups referenced above.

• The applicant company must be based in the UK.

• Life Science Companies must be a member of the ABPI, the UK BioIndustry Association, or the ABHI.

• The applicant understands the restrictions around the use of the data, and that these are legal in nature.

• The purpose for which the data will be used aligns with the purposes described in this document.

Life Science Companies are a user of the aggregated outputs exclusively for the purpose of using Meditrends Online to benefit the health and social care organisations in England. Life Science Companies users will be highly restricted in their use of Meditrends Online to ensure aggregated HES data are not used for commercial purposes such as targeting sales resource. These restrictions are underpinned through a binding legal contract which contains terms which require:

• The system to be used exclusively for the purpose of provision of outputs to assist health and social care organisations or patient support groups & other health related charitable organisations in England

• The system not to be used for solely commercial purposes

• The system only to be provided to a restricted number of named users, who have undergone and passed HES Protocol training underlining the need for non-commercial reuse All named users to authenticate sign on through unique password protection

• Passwords to be changed routinely

Life Science Companies abide by the established Prescription Medicines Code of Practice Authority (PMCPA) Code of Practice and Department of Health (DH) governance on the use of healthcare data by Life Science Companies with health and social care.

Meditrends ensure that registered users are not using the data for solely commercial purposes by requiring each user to undertake a thorough online governance training, which provides information on:

• The content of HES data.

• Presenting the data so it meets the requirements of the HES Analysis Guide (i.e. all outputs are aggregated with small number suppression in line with the HES Analysis Guide.)

• The specific purposes for which HES data accessed via Meditrends Online can be used (i.e. as specified in this agreement).

• The need to acknowledge copyright using the appropriate NHS Digital copyright statement.

•

All data on Meditrends Online is aggregated data with small number suppressed.

Purpose 2

Meditrends Limited receives requests (as part of projects led or initiated by NHS organisations) for suppressed, aggregated, non-sensitive, non-identifiable tabulated data both on an ad-hoc basis and as part of longer term healthcare development projects. These requests may be limited to the provision of aggregated HES data or may require the provision of analysis and interpretation. The analyses Meditrends Limited undertakes are complicated and are required in rapid timeframes to achieve NHS and social care project objectives. In all cases, projects are led by NHS organisations or by other organisations in partnership with or in response to requests for information from NHS organisations or affiliated bodies, including NICE.

The users of custom analyses are:

• Public Sector Organisations responsible for the planning, evaluation, commissioning or provision of health and social care focussing on Academic Health Science Networks (AHSN) and NHS partners.

• Life Science Companies (pharmaceutical, medical technology, and medical biotechnology)

In all cases, the data can only be used where the ultimate beneficiary is the NHS and Social Care. The Meditrends Directors assess all applications against the following criteria:

• The applicant must belong one of the customer groups referenced above.

• The applicant company must be based in the UK.

• Life Science Companies must be a member of the ABPI, the UK BioIndustry Association, or the ABHI.

• The applicant understands the restrictions around the use of the data, and that these are legal in nature.

• The purpose for which the data will be used aligns with the purposes described in this document.

All projects must be led by NHS organisations or by other organisations in partnership with, or undertaken in response to requests for information from NHS organisations or affiliated bodies, including NICE.

All users of custom analyses have a contract with Meditrends and, as such, it is mandatory for them to:

• Demonstrate how the analysis will benefit health and social care in England.

• Agree to a publication and communications plan to ensure that the results of the analysis are delivered in a non-promotional manner to the benefit of health and social care.

• Agree to share these plans in confidence with NHS digital.

It should be noted that Meditrends Ltd have turned down projects in the last year where the purpose was not felt to meet these requirements. As at February 2020, new projects are taking place, and proposals are also being considered for new custom analyses.

Episode level HES data and HES linked mortality data are required for both purpose 1 and 2.

• Purpose 1 (Meditrends online) is primarily based on admitted patient care data (APC) and HES linked mortality. However, it is planned to include outpatient and critical care analytics in the future.

• Purpose 2 (custom reports) make use of APC, outpatient and critical care datasets as well as HES-linked mortality data, for example, in order to assess the clinical burden of a disease or to compare various pathways.

• Only pseudonymised data is requested. This is necessary to produce analytics used for both purposes, for example to calculate the total incidence and prevalence of a condition.

For purpose 1, ten years of data is required to calculate incidence of a disease (the number of newly diagnosed/admitted patients each year).

For purpose 2, in general only five years data will be used for analysis purposes. However, occasionally ten years is required because:

• A cohort may need to be followed for more than five years after a particular intervention

• A rare condition may mean that a larger subject pool is needed to achieve a statistically significant cohort size.

Where more than five years data is required under purpose 2, Meditrends will submit a specific amendment to this agreement to make it clear how much data is being used.

For both purpose 1 and purpose 2 it is necessary to use data across England so that geographical variation in patterns of care can be assessed for benchmarking purposes and resource planning.

There are no other sources of data available which provide individual level information to achieve the defined purpose.

MINIMISATION

All datasets requested are required for benchmarking and epidemiological analyses. Only pseudonymised data is used, and only aggregated, small number suppressed information is released.

At present for purpose 1 ten years data is required in order to provide an accurate estimate of disease incidence (the number of new patients) and to assess outcomes (for survival time from first diagnosis).

The availability of ten years data allows statistically significant cohorts to be studied in the case of some rare conditions. In most cases, only five years data will be used and exceptions will be detailed in the subsequent agreement with NHS Digital.

Only data fields required for the purposes detailed above are requested. No fields classed as sensitive or ‘high risk’ are requested. Only month and year of birth and death are requested. For critical care and outpatient data, only five years will be held and historic data is deleted on a rolling basis.

Cohorts / Linkages:

Meditrends Ltd is the sole data controller and processor.

Client organisations request analyses, and may be responsible for publishing final reports. They may specify the types of analysis to be carried out, but at no time have access to patient level data.

There are no other funders/commissioners involved in the data analysis.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide

Dissemination and communication of results/outputs

Purpose 1

The Meditrends online portal is available free of charge to NHS employees (anyone with an NHS domain email address). Other interested parties can register with the site and, subject to validation can gain access to analytical tools.

Meditrends online is an interactive website that allows users to view aggregated information on epidemiology and clinical activity across all diagnoses and procedures (as classified under ICD 10 and OPCS coding systems) by provider (to trust level) and commissioner (to CCG level). Information on the portal is presented in the form of charts, maps and tables which can be viewed on screen or downloaded in various formats (graphics, spreadsheets etc.).

This can be used to inform planning decisions as described in section 5a. No episode level information is presented through the website.

Purpose 2

As part of engagement with clients at the start of a new project, a plan is agreed by which the results of the analyses will be communicated to NHS stakeholders and other relevant parties (patient support groups, scientific community etc). This plan will include target dates, communication channels and journals.

No client organisations or users of Meditrends online have access to the data, only aggregated and small number suppressed information is released to the clients.

Target dates for production of outputs

Purpose 1

Meditrends online is updated regularly as new data is received

Purpose 2

For each project, target dates for analysis completion and communication are agreed with client organisations

Previously stated target dates/deliverables.

Purpose 1

The website is updated as new data is incorporated. Typically this comprises of updating trend data to include the latest time points, but may involve addition of new measures in response to user feedback.

Purpose 2

Completed projects are listed in appendix details of completed and ongoing projects which have been supplied to NHS Digital in confidence. Some examples of completed projects are shown below:

A project to explain the 2016/17 NHS financial year Tariff payment for common heart valve procedures under changes made by the HRG4+ System.

The anticipated benefit to healthcare is to ensure that Trust performing heart valve

surgery/procedures understand the impact of HRG4+ the complex changes in HRG4+ on tariff payments for each procedure type. This will improve the consistency of coding across trusts and ensure that trusts receive correct payment for procedures benefiting the management & efficiency of the NHS.

Communicated information will be made directly to Key NHS stakeholders via Submission to NHS Improvement to ensure that specific heart valve procedures are eligible for a specialised services “Top-up” Tariff when performed by cardiac surgeons (not only by cardiologists)

Guide to the impact of HRG4+ developed and published illustrating the most common heart valve surgery complications and comorbidities (“CCs”).

In April 2018 another project was a report used to understand geographic equity of access to Transcatheter aortic valve implantation (TAVI) in the NHS in England.

The anticipated benefit to healthcare from the analysis is a more informed discussion & decision making regarding access to TAVI services in England.

Communicated results from this report with NHS Trusts for use in discussions regarding commissioning of TAVI services.

A presentation was developed for NHS Trusts providing TAVI services in the North of England showing lower access to TAVI for patients in the North across a variety of metrics, which was used to provide input into the review of TAVI commissioning in the North.

Meditrends online is now available (at Meditrends.co.uk) and users are able to view interactive maps, dashboards and tables showing commissioner and provider organisations. Registration and access to the site is available without charge to anyone with an NHS email address. New users are required to complete an online training module that covers governance of aspects of the data.

All data on the site is aggregated with small numbers and sensitive conditions suppressed in line with HES guidelines. No episode level data is held on the website server.

Measures reported include spell counts (admissions), bed days, unplanned vs elective admissions, costs (based on reported HRG code), demographics (age and sex) as well as estimated incidence and prevalence. Meditrends Ltd is working with a number of organisations and individuals within NHS to make the site as useful as possible.

To date, approximately 75% of registered users are based in NHS organisations, including Trusts, clinical commissioning groups and Area Health Science Networks across England.

In addition, custom analyses have been undertaken, examples of which are:

• Deep Vein Thrombosis (DVT) :

25,000 people in the UK die from preventable hospital-acquired DVT. Working with our client and a leading NHS vascular specialist clinician, Meditrends Ltd carried out a HES based analysis, looking at the economic and clinical impact of preventable deep vein thrombosis. The results were used to develop and support non-branded education and awareness programme for patients and clinicians in hospitals in England. This campaign was designed to complement the introduction of mandatory in-patient DVT assessment across NHS England.

This was part of a wider programme, aimed at increasing awareness of the risks of DVT. Meditrends Ltd was not involved in following up outcomes or monitoring the overall success of the campaign.

• Healthcare Resource Group version 4+ (HRG4+), Proposed Introduction:

In response to planned structural changes to the Healthcare Resource Grouping (HRG) system, whereby trusts are reimbursed for procedures carries out, Meditrends Limited was requested to undertake an analysis of the impact of the introduction of complications and co-morbidity stratification in HRG4+ on heart surgery NHS national tariffs. By analysing historic HES data Meditrends Limited identified the key co-morbidities that drove variation in tariff outcomes across the 30 designated heart surgery centres. Meditrends Ltd prepared non-branded, educational material for distribution to all relevant centres alerting them to the impact of the changes which in some cases may have a material impact on centre viability.

The construction of these analyses are highly dynamic in nature requiring Meditrends Limited to work in an iterative fashion to analyse data, assess outputs, refine search and resubmit until the exact answer to the initial question has been found. Typically, the process takes several iterations to achieve the required outputs.

Historically, 80% of custom projects have not focussed on specific pharmaceutical products but have involved developing understanding and awareness of epidemiology, burden of disease on the NHS and patient treatment pathways. However, a minority of projects have been focussed on specific products where there is also a benefit to Health and Social Care. Examples from two different projects involving the management of multiple sclerosis are:

• NICE Health Technology Assessment (HTA):

In the NICE Technology appraisal of a novel Multiple Sclerosis (MS) agent the manufacturer was asked to address questions raised in the evaluation report about current treatments for MS relapse. Meditrends Limited undertook an analysis of admission patterns and costs associated with MS relapses. By providing evidence of actual clinical practice in England in respect of the administration of intravenous corticosteroids post relapse, NICE approval facilitated which made the treatment accessible to MS patients in England. Since NICE approval an estimated 8,000 MS patients have benefitted from this therapy

• MS Treatment Outcomes:

In response to requests by clinicians at NHS MS centres for evidence of efficacy in UK clinical practice and beyond the period studied in clinical trials, Meditrends Limited worked with the developer of natilizumab, a novel disease modifying agent to undertake an cohort analysis, following MS patients over a period of four years before and after start of treatment. Meditrends Ltd were able to demonstrate significant improvements in patient outcomes in terms of reducing the number of hospital admissions, emergency admissions and length of stay. Because HES data allowed follow up beyond the length of clinical trials it contributed to understanding the costs and benefits to the NHS of use beyond clinical trial period. The results of the analysis were shared with neurologists from major MS centres in a non-branded advisory board and presented as a poster in 2013 at the annual conference of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Other studies have used HES data to help clients engage with NHS organisations at national and sub-national (e.g. CCG, hospital trust) level to demonstrate the potential clinical and financial impact of new treatment pathways in a variety of fields. These include:

• Pulmonary arterial hypertension: a study undertaken to improve patient management by analysing local variations in access to optimal treatment pathways and compliance with NICE guidelines.

• Parkinson’s disease: An epidemiological study of comorbidity and clinical burden of patients with advanced disease to support with planning for the cost-effective introduction of a novel treatment pathway.

• Diabetes: Analysis of the burden of disease of this chronic condition to support local monitoring and patient management.

• Age-related macular degeneration: Comparison of alternative treatment pathways in preventing blindness and to demonstrate the cost benefit of an innovative approach to treatment in support of an anticipated NICE appraisal.

• Heart/renal failure: Study to understand the predictors of renal complications in heart failure patients to facilitate introduction of a new treatment to potentially prevent or delay progression to renal failure dialysis.

• Deep vein thrombosis: Providing evidence to support an educational programme supporting preventative treatment to avoid complications following surgery.

• Acute Lymphoblastic Leukaemia (ALL): Analysis of referral patterns and treatment pathways to improve patient access and optimise delivery of treatment.

• Heart Valve Disease (multiple projects): Demonstrating the beneficial outcomes following surgical correction of valve defects in patients with mitral and aortic valve disease.

• Crohn’s disease/ulcerative colitis: Comparison of the impact on clinical budgets of hospital and home delivered treatment options.

• Critical limb ischaemia: Analysis of risk factors in patients with peripheral vascular disease to support registration and introduction of a new treatment to prevent complications leading to amputation.

• Bladder cancer: Assessment of the clinical and financial impact of a new diagnostic technique to improve detection and resection rates.

• Neuroendocrine Tumours (NET): Epidemiological study to assess potential impact of a new treatment providing symptomatic relief in a small sub-group of NET patients.

• Respiratory disease in infants: Epidemiological study of infections with respiratory syncytial virus (RSV) in vulnerable infants to support ongoing vaccination programme.

In every case, the ultimate beneficiary, either directly or indirectly has been the Health and Social Care system. Amongst other benefits, the analyses, reports and tools provided have positively promoted the delivery of healthcare by:

• Supporting the commissioning cycle by facilitating evidence-based decision making at a local level.

• Enabling the introduction of new treatment options by providing real world evidence of cost-effectiveness and improved clinical outcomes to commissioners, providers and national bodies such as NICE.

• Helping to improve clinical practice by supporting the delivery of educational programmes.

More recent projects are delivering the following benefits:

• Helping NHS commissioners and providers understand the impact of the introduction of HRG4+ on a range of surgical interventions, enabling them to optimise the cost-effective management of patients undergoing complex procedures.

• Identifying areas where novel surgical techniques may reduce costs, whilst improving efficiency and outcomes.

• Providing answers to questions from regulatory authorities and commissioning organisations, based on real-world evidence, to support the expand the availability of a therapy for patients with inherited blood disorders, for which there is currently no effective treatment other than frequent, lifelong blood transfusions.

• Advising commissioners and other NHS affiliated organisations on the potential costs and benefits of a novel treatment for severe, treatment-resistant epilepsy.

• Helping commissioners understand geographical variation in management of patients with Parkinson's disease, improving timely referral to tertiary treatment centres.

• Helping commissioners and providers to configure resources for patients with a variety of heart valve disorders, improving equality of access and reducing geographical variation, including commissioning a new specialist surgical centre.

Meditrends Limited (incorporated in 2013, taking over the business of Beacon Consulting) require Hospital Episode Statistics (HES) data linked to Civil Registration mortality data solely for the following purposes (any other purposes will be subject to an amended application).

GDPR LEGAL BASIS

Meditrends process data in accordance with their legitimate interests under GDPR, as summarised below:

1. Purpose test: are you pursuing a legitimate interest? Meditrends Ltd processes Hospital Episode Statistics (HES) and Civil Registration mortality data in order to provide analysis and interpretation of performance and quality issues within healthcare to doctors, clinicians and managers of NHS and Social Care providers.

2. Necessity test: is the processing necessary for that purpose? The processing activity is important as it offers NHS providers a mechanism to scrutinise and compare clinical services, which in turn informs improvements in terms of efficiency and quality of services. There is no other way of achieving this objective, as HES data is the prime, comprehensive record of hospital activity across England, and the Civil Registration mortality data is the prime, comprehensive record of mortality data.

3. Balancing test: do the individual’s interests override the legitimate interest? Meditrends Ltd only process pseudonymised patient data (as anonymised with the ICO's code of practice). There is no direct relationship and collection of information from the data subjects (e.g. patients). All data is held securely and all outputs are aggregated with small numbers suppressed. Members of the public may reasonably expect that NHS providers use a range of tools and methods to review and monitor the quality and efficiency of the services that they provide. Meditrends Ltd provide a privacy notice on their website, specifying the details of the processing as per GDPR requirements.

The requirement for the HES data to be linked to mortality data is an amendment to previous versions of this agreement:

PURPOSE 1): MEDITRENDS ONLINE

Meditrends Online aims to improve the ease with which key stakeholders in the commissioning cycle can access and use important health measures.

Meditrends Online is a web delivered system that uses aggregated, supressed, non-sensitive, non-identifiable HES data to:

• Identify areas of clinical need to help inform planning decisions and research programmes.

• Understand local and national epidemiology, and the efficiency of existing clinical pathways and services.

• Model more efficient, integrated (between health and social care) pathways and services.

• Monitor the success of newly implemented pathways and services.

The current users of Meditrends Online are:

• Public Sector Organisations responsible for the planning, evaluation, commissioning or provision of health and social care including:

o NHS England organisations including: Clinical Commissioning groups, GP practices, Acute Trusts, Area & Regional Teams

o Government & government aligned groups: DH, NHS England, NICE and Academic Health Science Networks (AHSN), NHS England Commissioning Support Units (CSUs)

• Life Science Companies (pharmaceutical, medical technology, and medical biotechnology);

All Life Science Companies are required to be members of the Association of British Pharmaceutical Companies (ABPI); the UK BioIndustry Association or the Association of British Healthcare Industries (ABHI)

Meditrends Online outputs will be used by the ultimate beneficiary to optimise the Commissioning Cycle in the following ways:

• To assess performance against similar organisations and to understand where change could be required to achieve Quality Innovation Productivity and Prevention (QIPP) planning.

• To communicate with all stakeholders in explaining the rationale for change and to create engagement with users to understand their needs in the commissioning process.

• To identify areas of best practice in disease management. To use this data to define, monitor and communicate critical indicators of success.

• To forecast future levels of demand for services and configure local resources to meet these needs

Although the users of Meditrends Online are all of the above groups, the data can only be used for the purposes listed above, with the ultimate beneficiary in all cases being the NHS and Social Care. All users will give an undertaking to this effect, and all applications to become registered users are assessed by the Meditrends Directors against the following criteria:

• The applicant must belong to one of the customer groups referenced above.

• The applicant company must be based in the UK.

• Life Science Companies must be a member of the ABPI, the UK BioIndustry Association, or the ABHI.

• The applicant understands the restrictions around the use of the data, and that these are legal in nature.

• The purpose for which the data will be used aligns with the purposes described in this document.

Life Science Companies are a user of the aggregated outputs exclusively for the purpose of using Meditrends Online to benefit the health and social care organisations in England. Life Science Companies users will be highly restricted in their use of Meditrends Online to ensure aggregated HES data are not used for commercial purposes such as targeting sales resource. These restrictions are underpinned through a binding legal contract which contains terms which require:

• The system to be used exclusively for the purpose of provision of outputs to assist health and social care organisations or patient support groups & other health related charitable organisations in England

• The system not to be used for solely commercial purposes

• The system only to be provided to a restricted number of named users, who have undergone and passed HES Protocol training underlining the need for non-commercial reuse All named users to authenticate sign on through unique password protection

• Passwords to be changed routinely

• Life Science Companies to abide by the established Prescription Medicines Code of Practice Authority (PMCPA) Code of Practice and Department of Health (DH) governance on the use of healthcare data by Life Science Companies with health and social care.

Meditrends ensure that registered users are not using the data for solely commercial purposes by requiring each user to undertake a thorough online governance training, which provides information on:

• The content of HES data.

• Presenting the data so it meets the requirements of the HES Analysis Guide (i.e. all outputs are aggregated with small number suppression in line with the HES Analysis Guide.)

• The specific purposes for which HES data accessed via Meditrends Online can be used (i.e. as specified in this agreement).

• The need to acknowledge copyright using the appropriate NHS Digital copyright statement.

All data on Meditrends Online is aggregated data with small number suppression as described below in Processing Activities (Data Release).

Under purpose 1, Meditrends requires 10 years of data, specifically in order to report long term trends in disease incidence (number of newly diagnosed patients). For many conditions, admissions to hospital are relatively infrequent (especially in the early stages), so it is important to have an extended view of historical data in order to distinguish new patients from previously diagnosed (prevalent) ones. For example, it might be important for breast cancer admissions to distinguish newly diagnosed patients from those who may have had the condition previously, in order to assess the success of a screening programme. Although the website only reports five years of data, Meditrends need to be able to look further back to identify new cases. To be completely accurate would require data going back even further, but 10 years should provide a reasonable estimate for most conditions.

PURPOSE 2: CUSTOM ANALYSES

Meditrends Limited receives requests (as part of projects led by NHS organisations) for suppressed, aggregated, non-sensitive, non-identifiable tabulated data both on an ad-hoc basis and as part of longer term healthcare development projects. These requests may be limited to the provision of aggregated HES data or may require the provision of analysis and interpretation. The analyses Meditrends Limited undertakes are complicated and are required in rapid timeframes to achieve NHS and social care project objectives. In all cases, projects are led by NHS organisations or by other organisations in partnership with or in response to requests for information from NHS organisations or affiliated bodies, including NICE.

In addition to the purposes outlined in purpose 1 above, the specific purposes are:

• Identifying areas of unmet clinical need.

• Providing information about budget impact of new technologies.

• Comparing effectiveness and cost-effectiveness of alternative care pathways.

• Supporting best practice in healthcare delivery.

The users of custom analyses are:

• Public Sector Organisations responsible for the planning, evaluation, commissioning or provision of health and social care focussing on Academic Health Science Networks (AHSN) and NHS partners.

• Life Science Companies (pharmaceutical, medical technology, and medical biotechnology)

In all cases, the data can only be used where the ultimate beneficiary is the NHS and Social Care. The Meditrends Directors assess all applications against the following criteria:

• The applicant must belong one of the customer groups referenced above.

• The applicant company must be based in the UK.

• Life Science Companies must be a member of the ABPI, the UK BioIndustry Association, or the ABHI.

• The applicant understands the restrictions around the use of the data, and that these are legal in nature.

• The purpose for which the data will be used aligns with the purposes described in this document.

• All projects must be led by NHS organisations or by other organisations in partnership with, or undertaken in response to requests for information from NHS organisations or affiliated bodies, including NICE.

All users of custom analyses have a contract with Meditrends and, as such, it is mandatory for them to:

• Demonstrate how the analysis will benefit health and social care in England.

• Agree to a publication and communications plan to ensure that the results of the analysis are delivered in a non-promotional manner to the benefit of health and social care.

• Agree to share these plans in confidence with NHS digital and IGARD.

It should be noted that Meditrends Ltd have turned down projects in the last year where the purpose was not felt to meet these requirements. As at December 2018, new projects are taking place, and proposals are also being considered for new custom analyses.

Under purpose 2, 5 years data is required for benchmarking purposes. Where 10 years data may be required for particular projects, the applicant will submit an amendment to request that data for the project in question only. As at December 2018, 10 years data is required for one project, "Co-morbidities and mortality associated with Transfusion Dependent Beta-thalassaemia (BTH) Patients in England: A 10-Year Retrospective Cohort Analysis", further details of which are provided in the next section of this agreement.

Since 2007 Meditrends Ltd has provided HES analyses to around 20 different organisations in the UK pharmaceutical and device industries. Typically there are four or five active projects at any particular time. A selection of representative examples are reported in the outputs and benefits of this document.

REQUIREMENT FOR MORTALITY DATA

Purpose 1:

The Meditrends site currently reports estimates of disease incidence and prevalence, based on admissions to hospital, which are useful in building epidemiological models to help plan future demand for health and social care resource. Having access to mortality data will greatly improve the accuracy of these estimates, particularly for chronic conditions, where patients may visit hospital less than once a year. Furthermore it will be possible to develop more accurate outcome measures, by excluding deceased patients from the calculations. As mentioned previously, this data will enable survival metrics to be reported as well as mortality rates.

Purpose 2:

Some projects require estimates of mortality to be made. Without Civil Register mortality information, Meditrends can only report on deaths where these have occurred in hospital. Inevitably, there will be a proportion of the study cohort who have not attended hospital for some time and it is uncertain whether they are 'cured', deceased or lost to follow-up. In some cases this group can be very large, reducing the reliability of the study significantly. The ability to improve estimates of mortality will greatly increase the power of these analyses to support planning and other decision making processes in the health system.

Purpose 1): Meditrends Online

Meditrends Online is a website that gives users access to a wide range of HES derived healthcare analytics though an intuitive user interface. These analytics will include hospital activity, disease epidemiology and health economic metrics, summarised at various geographical levels. The site went live as a pilot in April 2017 and uptake has been extremely encouraging since then. More information on the user base is provided under yielded benefits, below.

In the near future the range of interactive maps will be extended, enabling users to see for example all CCGs in England mapped and colour coded according to various measures for any disease or procedure (subject to small number limitations), allowing geographic variations to be identified quickly and easily. Additional statistical functionality will be added, including the ability to visualise correlations between metrics across geographic ranges.

HES linked mortality data will significantly extend the number of measures included on the list of available metrics, such as:

Mortality by cause

and all cause

5 year survival rate

Purpose 2): Custom Analysis

Custom analyses are produced as requested by 3rd parties. Outputs take the form of:

• Interactive spreadsheet applications

• Documents in Word or pdf format

• Reports in a password protected area of the Meditrends website

• PowerPoint presentations.

For study 1 (detailed in processing activities), the expected outputs are:

A submission to the British Haemotology Journal is planned for 2019.

In addition, the results of the analysis will be communicated directly to haematologists who treat TDT patients and the UK Thalassaemia society (the patient support group for TDT patients) by providing them with links to the online journal and off-prints of the paper. It is also expected that the paper will be referenced in future submissions to NICE and/or NHS England seeking funding for new treatments for TDT. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

Meditrends online is now available (at Meditrends.co.uk) and users are able to view interactive maps, dashboards and tables showing commissioner and provider organisations. Registration and access to the site is available without charge to anyone with an NHS email address. New users are required to complete an online training module that covers governance aspects of the data.

All data on the site is aggregated with small numbers and sensitive conditions suppressed in line with HES guidelines. No episode level data is held on the website server.

Measures reported include spell counts (admissions), bed days, unplanned vs elective admissions, costs (based on reported HRG code), demographics (age and sex) as well as estimated incidence and prevalence. Meditrends Ltd is working with a number of organisations and individuals within NHS to make the site as useful as possible.

To date, approximately 75% of registered users are based in NHS organisations, including Trusts, clinical commissioning groups and Area Health Science Networks across England.

In addition, custom analyses have been undertaken, examples of which are:

• Deep Vein Thrombosis (DVT) :

25,000 people in the UK die from preventable hospital-acquired DVT. Working with our client and a leading NHS vascular specialist clinician, Meditrends Ltd carried out a HES based analysis, looking at the economic and clinical impact of preventable deep vein thrombosis. The results were used to develop and support non-branded education and awareness programme for patients and clinicians in hospitals in England. This campaign was designed to complement the introduction of mandatory in-patient DVT assessment across NHS England.

• Healthcare Resource Group version 4+ (HRG4+), Proposed Introduction:

In response to planned structural changes to the Healthcare Resource Grouping (HRG) system, whereby trusts are reimbursed for procedures carries out, Meditrends Limited was requested to undertake an analysis of the impact of the introduction of complications and co-morbidity stratification in HRG4+ on heart surgery NHS national tariffs. By analysing historic HES data Meditrends Limited identified the key co-morbidities that drove variation in tariff outcomes across the 30 designated heart surgery centres. Meditrends Ltd prepared non-branded, educational material for distribution to all relevant centres alerting them to the impact of the changes which in some cases may have a material impact on centre viability.

The construction of these analyses are highly dynamic in nature requiring Meditrends Limited to work in an iterative fashion to analyse data, assess outputs, refine search and resubmit until the exact answer to the initial question has been found. Typically, the process takes several iterations to achieve the required outputs.

Historically, 80% of custom projects have not focussed on specific pharmaceutical products but have involved developing understanding and awareness of epidemiology, burden of disease on the NHS and patient treatment pathways. However, a minority of projects have been focussed on specific products where there is also a benefit to Health and Social Care. Examples from two different projects involving the management of multiple sclerosis are:

• NICE Health Technology Assessment (HTA):

In the NICE Technology appraisal of a novel Multiple Sclerosis (MS) agent the manufacturer was asked to address questions raised in the evaluation report about current treatments for MS relapse. Meditrends Limited undertook an analysis of admission patterns and costs associated with MS relapses. By providing evidence of actual clinical practice in England in respect of the administration of intravenous corticosteroids post relapse, NICE approval facilitated which made the treatment accessible to MS patients in England. Since NICE approval an estimated 8,000 MS patients have benefitted from this therapy

• MS Treatment Outcomes:

In response to requests by clinicians at NHS MS centres for evidence of efficacy in UK clinical practice and beyond the period studied in clinical trials, Meditrends Limited worked with the developer of natilizumab, a novel disease modifying agent to undertake an cohort analysis, following MS patients over a period of four years before and after start of treatment. Meditrends Ltd were able to demonstrate significant improvements in patient outcomes in terms of reducing the number of hospital admissions, emergency admissions and length of stay. Because HES data allowed follow up beyond the length of clinical trials it contributed to understanding the costs and benefits to the NHS of use beyond clinical trial period. The results of the analysis were shared with neurologists from major MS centres in a non-branded advisory board and presented as a poster in 2013 at the annual conference of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Other studies have used HES data to help clients engage with NHS organisations at national and sub-national (e.g. CCG, hospital trust) level to demonstrate the potential clinical and financial impact of new treatment pathways in a variety of fields. These include:

• Pulmonary arterial hypertension: a study undertaken to improve patient management by analysing local variations in access to optimal treatment pathways and compliance with NICE guidelines.

• Parkinson’s disease: An epidemiological study of comorbidity and clinical burden of patients with advanced disease to support with planning for the cost-effective introduction of a novel treatment pathway.

• Diabetes: Analysis of the burden of disease of this chronic condition to support local monitoring and patient management.

• Age-related macular degeneration: Comparison of alternative treatment pathways in preventing blindness and to demonstrate the cost benefit of an innovative approach to treatment in support of an anticipated NICE appraisal.

• Heart/renal failure: Study to understand the predictors of renal complications in heart failure patients to facilitate introduction of a new treatment to potentially prevent or delay progression to renal failure dialysis.

• Deep vein thrombosis: Providing evidence to support an educational programme supporting preventative treatment to avoid complications following surgery.

• Acute Lymphoblastic Leukaemia (ALL): Analysis of referral patterns and treatment pathways to improve patient access and optimise delivery of treatment.

• Heart Valve Disease (multiple projects): Demonstrating the beneficial outcomes following surgical correction of valve defects in patients with mitral and aortic valve disease.

• Crohn’s disease/ulcerative colitis: Comparison of the impact on clinical budgets of hospital and home delivered treatment options.

• Critical limb ischaemia: Analysis of risk factors in patients with peripheral vascular disease to support registration and introduction of a new treatment to prevent complications leading to amputation.

• Bladder cancer: Assessment of the clinical and financial impact of a new diagnostic technique to improve detection and resection rates.

• Neuroendocrine Tumours (NET): Epidemiological study to assess potential impact of a new treatment providing symptomatic relief in a small sub-group of NET patients.

• Respiratory disease in infants: Epidemiological study of infections with respiratory syncytial virus (RSV) in vulnerable infants to support ongoing vaccination programme.

In every case, the ultimate beneficiary, either directly or indirectly has been the Health and Social Care system. Amongst other benefits, the analyses, reports and tools provided have positively promoted the delivery of healthcare by:

• Supporting the commissioning cycle by facilitating evidence-based decision making at a local level.

• Enabling the introduction of new treatment options by providing real world evidence of cost-effectiveness and improved clinical outcomes to commissioners, providers and national bodies such as NICE.

• Helping to improve clinical practice by supporting the delivery of educational programmes.

More recent projects are delivering the following benefits:

• Helping NHS commissioners and providers understand the impact of the introduction of HRG4+ on a range of surgical interventions, enabling them to optimise the cost-effective management of patients undergoing complex procedures.

• Identifying areas where novel surgical techniques may reduce costs, whilst improving efficiency and outcomes.

• Providing answers to questions from regulatory authorities and commissioning organisations, based on real-world evidence, to support the expand the availability of a therapy for patients with inherited blood disorders, for which there is currently no effective treatment other than frequent, lifelong blood transfusions.

• Advising commissioners and other NHS affiliated organisations on the potential costs and benefits of a novel treatment for severe, treatment-resistant epilepsy.

• Helping commissioners understand geographical variation in management of patients with Parkinson's disease, improving timely referral to tertiary treatment centres.

• Helping commissioners and providers to configure resources for patients with a variety of heart valve disorders, improving equality of access and reducing geographical variation, including commissioning a new specialist surgical centre.