Title: Researching the Umpire Processes for Economic Evaluation in the NHS - RUPEE(NHS)
Funder: Department of Health (England)

Abstract: Background CVD is a major cause of mortality but lifestyle and pharmacological management can be effective at prolonging and improving life for those at high risk. Multi-medication regimes are recommended for these patients to manage hypertension, raised lipids and platelet aggregation. Regime complexity impacts adversely on adherence to such treatment , and therefore on its effectiveness. In the UMPIRE Trial, an FDC single pill incorporating anti-hypertensives, statin and aspirin was found to significantly improve adherence to treatment and to lower systolic blood pressure and LDL cholesterol. An FDC regime may therefore produce better long-term clinical effects than conventional multi-tablet regimes. RUPEE(NHS) is a health economic evaluation of the UMPIRE Trial in England. Aims RUPEE(NHS) will estimate the cost-effectiveness and budget impact of switching high risk cardiovascular patients from usual care with multi-tablet regimes to a cardiovascular FDC. It will also assess the extent of uncertainty over the cost-effectiveness of the FDC, and estimate the value of conducting further research to reduce this. These questions are likely to be key for NHS prescribing policy in the wake of the UMPIRE Trial. Plan of investigation Data extraction from UMPIRE case report forms, adverse event forms, quality of life questionnaires etc. Within-trial economic analysis of UMPIRE data. Treatment and cardiovascular-related healthcare costs over the trial period will be estimated from individual resource use data and national unit costs. Regression methods will be used to estimate the impact of the FDC on mean healthcare costs and cost effectiveness. Results of this analysis will be used to inform the economic model. Model development. A systematic review of economic models of high-risk cardiovascular prevention and reviews for sources of data for model parameters will be undertaken. Alternative model structures and data sources will be described and discussed with collaborators and other clinical and patient experts. Once the model architecture has been agreed, it will be programmed and populated with data. Model verification and validation - conducted by an expert external to the modelling team. Model analysis: Use of the model to estimate long-run cost-effectiveness and budget/health impacts; subgroup analysis and sensitivity analysis. Overall interpretation and analysis, reporting and dissemination. Potential benefit to patients and NHS RUPEE(NHS) has potential to provide good data on whether or not an FDC is an effective, cost-effective and affordable means of addressing a major public health issue, i.e. prevention of CVD progression and acute events in those at high risk. UMPIRE trial results support this view [1], and there is therefore potential for substantial savings in NHS prescribing budgets and in the resources required for follow-up and CVD care. For some individual patients, there may be savings on prescription charges but, for all patients, there would be a simplification of their treatment.This could promote quality of life and better adherence, and hence improve CVD prevention with health benefits for patients. However, there are also potential disadvantages with an FDC regimen: treatment cannot be targeted to optimise individual response or to avoid perceived side-effects. It is therefore important that evidence from the UMPIRE trial about efficacy of the FDC is extended to estimate the net health impact for patients, long-run (lifetime) cost-effectiveness and net cost-impact for the health service. The extent of uncertainty over the cost and benefit of an FDC strategy will be investigated and used to assess the expected value of conducting further research through controlled trials or observational studies.


Research activity codes: 8.2 HEALTH AND WELFARE ECONOMICS;3.3 NUTRITION AND CHEMOPREVENTION
Health categories: STROKE;CARDIOVASCULAR