A Protocol for an economic evaluation of a polypill in patients with established or at high risk of cardiovascular disease in a UK NHS setting: RUPEE (NHS) study

Copyright © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. Introduction: The ‘Use of a Multi-drug Pill in Reducing cardiovascular Events’ (UMPIRE) trial was a randomised controlled clinical trial evaluating the impact of a polypill strategy on adherence to indicated medication in a population with established cardiovascular disease (CVD) of or at high risk thereof. The aim of Researching the UMPIRE Processes for Economic Evaluation in the National Health Service (RUPEE NHS) is to estimate the potential health economic impact of a polypill strategy for CVD prevention within the NHS using UMPIRE trial and other relevant data. This paper describes the design of a modelled economic evaluation of the impact of increased adherence to the polypill versus usual care among the UK UMPIRE participants. Methods and analysis: As recommended by the International Society for Pharmacoeconomics and Outcomes Research and the Society for Medical Decision Making modelling guidelines, a review of published CVD models was undertaken to identify the most appropriate modelling approach and structure. The review was carried out in the electronic databases, MEDLINE and EMBASE. 40 CVD models were identified from 57 studies, the majority of economic models were health state transition cohort models and individual-level simulation models. The findings were discussed with clinical experts to confirm the approach and structure. An individual simulation approach was identified as the most suitable method to capture the heterogeneity in the population at CVD risk. RUPEE-NHS will use UMPIRE trial data on adherence to estimate the long-term cost-effectiveness of the polypill strategy. Dissemination: The evaluation findings will be presented in open-access scientific and healthcare policy journals and at national and international conferences. We will also present findings to NHS policy makers and pharmaceutical companies

Health Savings Account - Eligible High Deductible Health Plans: Updating the Definition of Prevention

High-deductible health plans (HDHPs) are an important and growing part of the health insurance landscape. By some estimates, as many as 80 percent of large employers may offer an HDHP in 2014. In 2013, more than 15 million Americans received health coverage through an HDHP, a more than a threefold increase since 2007.As outlined by the U.S. Treasury Department, individuals with an HSA-eligible HDHP are required to pay the full cost of most medications and services -- in theory utilizing pre-tax HSA funds -- until deductibles are met. However, the 2003 authorizing legislation and further guidance include a safe harbor allowing plans to cover primary preventive services, those typically deemed to prevent the onset of disease, before the deductible is satisfied.Services or benefits meant to treat "an existing illness, injury or condition," are excluded from first-dollar coverage in HSA-eligible HDHPs, which encompasses most secondary preventive services. For example, plans are prohibited from providing first dollar coverage of disease management services such as insulin, eye and foot exams, and glucose monitoring supplies for patients with diabetes.As chronic disease conditions currently make up 75 percent of total U.S. health spending, appropriate chronic disease management is an important tool to lower long-term health care costs. As the market for HDHPs grow, it is important that they maintain the flexibility to allow for effective health management of all beneficiaries. This report addresses the strict definition of prevention that an HDHP must follow for it to include a pre-tax health savings account (HSA), and how this restriction limits the effectiveness of current plans. A potential solution - allowing HSA-eligible HDHPs to provide first-dollar coverage for targeted, evidence-based, secondary preventive services that prevent chronic disease progression and related complications - can improve patient-centered outcomes, add efficiency to medical spending, and enhance HDHP attractiveness.A multi-disciplinary research team from the University of Michigan's Center for Value-Based Insurance Design, Harvard Medical School, and the University of Minnesota conducted a multi-part project to investigate the impact of updatingthe definition of prevention for HDHPs to include selected secondary preventive services that are frequently used as health plan quality metrics and included as elements of pay-for-performance programs. Specifically, the project aimed to: 1) determine the premium effect, actuarial value, and estimated market uptake of the novel HDHP plan that covers these evidence-based services outside the deductible, and 2) explore through interviews whether insurance industry experts found coverage of secondary preventive services a worthwhile endeavor

A protocol for an economic evaluation of a polypill in patients with established or at high risk of cardiovascular disease in a UK NHS setting: RUPEE (NHS) study.

INTRODUCTION: The 'Use of a Multi-drug Pill in Reducing cardiovascular Events' (UMPIRE) trial was a randomised controlled clinical trial evaluating the impact of a polypill strategy on adherence to indicated medication in a population with established cardiovascular disease (CVD) of or at high risk thereof. The aim of Researching the UMPIRE Processes for Economic Evaluation in the National Health Service (RUPEE NHS) is to estimate the potential health economic impact of a polypill strategy for CVD prevention within the NHS using UMPIRE trial and other relevant data. This paper describes the design of a modelled economic evaluation of the impact of increased adherence to the polypill versus usual care among the UK UMPIRE participants. METHODS AND ANALYSIS: As recommended by the International Society for Pharmacoeconomics and Outcomes Research and the Society for Medical Decision Making modelling guidelines, a review of published CVD models was undertaken to identify the most appropriate modelling approach and structure. The review was carried out in the electronic databases, MEDLINE and EMBASE. 40 CVD models were identified from 57 studies, the majority of economic models were health state transition cohort models and individual-level simulation models. The findings were discussed with clinical experts to confirm the approach and structure. An individual simulation approach was identified as the most suitable method to capture the heterogeneity in the population at CVD risk. RUPEE-NHS will use UMPIRE trial data on adherence to estimate the long-term cost-effectiveness of the polypill strategy. DISSEMINATION: The evaluation findings will be presented in open-access scientific and healthcare policy journals and at national and international conferences. We will also present findings to NHS policy makers and pharmaceutical companies

A Novel Chronic Disease Policy Model

We develop a simulation tool to support policy-decisions about healthcare for chronic diseases in defined populations. Incident disease-cases are generated in-silico from an age-sex characterised general population using standard epidemiological approaches. A novel disease-treatment model then simulates continuous life courses for each patient using discrete event simulation. Ideally, the discrete event simulation model would be inferred from complete longitudinal healthcare data via a likelihood or Bayesian approach. Such data is seldom available for relevant populations, therefore an innovative approach to evidence synthesis is required. We propose a novel entropy-based approach to fit survival densities. This method provides a fully flexible way to incorporate the available information, which can be derived from arbitrary sources. Discrete event simulation then takes place on the fitted model using a competing hazards framework. The output is then used to help evaluate the potential impacts of policy options for a given population.Comment: 24 pages, 13 figures, 11 table

Modelling the UK burden of cardiovascular disease to 2020

This new research report demonstrates the scale of the burden of cardiovascular disease (CVD) - shown to be large, costly, and increasing. Whilst mortality from CVD has fallen, an increasing population over the next decade will create further demands on services as the actual numbers of people living with CVD climb higher.<br /

Which interventions offer best value for money in primary prevention of cardiovascular disease?

BackgroundDespite many decades of declining mortality rates in the Western world, cardiovascular disease remains the leading cause of death worldwide. In this research we evaluate the optimal mix of lifestyle, pharmaceutical and population-wide interventions for primary prevention of cardiovascular disease.Methods and FindingsIn a discrete time Markov model we simulate the ischaemic heart disease and stroke outcomes and cost impacts of intervention over the lifetime of all Australian men and women, aged 35 to 84 years, who have never experienced a heart disease or stroke event. Best value for money is achieved by mandating moderate limits on salt in the manufacture of bread, margarine and cereal. A combination of diuretic, calcium channel blocker, ACE inhibitor and low-cost statin, for everyone with at least 5% five-year risk of cardiovascular disease, is also cost-effective, but lifestyle interventions aiming to change risky dietary and exercise behaviours are extremely poor value for money and have little population health benefit.ConclusionsThere is huge potential for improving efficiency in cardiovascular disease prevention in Australia. A tougher approach from Government to mandating limits on salt in processed foods and reducing excessive statin prices, and a shift away from lifestyle counselling to more efficient absolute risk-based prescription of preventive drugs, could cut health care costs while improving population health.<br /

Strategies for Primary Prevention of Coronary Heart Disease Based on Risk Stratification by the ACC/AHA Lipid Guidelines, ATP III Guidelines, Coronary Calcium Scoring...

Background: Several approaches have been proposed for risk-stratification and primary prevention of coronary heart disease (CHD), but their comparative and cost-effectiveness is unknown. Methods: We constructed a state-transition microsimulation model to compare multiple approaches to the primary prevention of CHD in a simulated cohort of men aged 45–75 and women 55–75. Risk-stratification strategies included the 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines on the treatment of blood cholesterol, the Adult Treatment Panel (ATP) III guidelines, and approaches based on coronary artery calcium (CAC) scoring and C-reactive protein (CRP). Additionally we assessed a treat-all strategy in which all individuals were prescribed either moderate-dose or high-dose statins and all males received low-dose aspirin. Outcome measures included CHD events, costs, medication-related side effects, radiation-attributable cancers, and quality-adjusted-life-years (QALYs) over a 30-year timeframe. Results: Treat-all with high-dose statins dominated all other strategies for both men and women, gaining 15.7 million QALYs, preventing 7.3 million myocardial infarctions, and saving over $238 billion, compared to the status quo, far outweighing its associated adverse events including bleeding, hepatitis, myopathy, and new-onset diabetes. ACC/AHA guidelines were more cost-effective than ATP III guidelines for both men and women despite placing 8.7 million more people on statins. For women at low CHD risk, treat-all with high-dose statins was more likely to cause a statin-related adverse event than to prevent a CHD event. Conclusions: Despite leading to a greater proportion of the population placed on statin therapy, the ACC/AHA guidelines are more cost-effective than ATP III. Even so, at generic prices, treating all men and women with statins and all men with low-dose aspirin appears to be more cost-effective than all risk-stratification approaches for the primary prevention of CHD. Especially for low-CHD risk women, decisions on the appropriate primary prevention strategy should be based on shared decision making between patients and healthcare providers

Designing and evaluating complex interventions to improve health care

Complex interventions are “built up from a number of components, which may act both independently and interdependently.”1 2 Many health service activities should be considered as complex. Evaluating complex interventions can pose a considerable challenge and requires a substantial investment of time. Unless the trials illuminate processes and mechanisms they often fail to provide useful information. If the result is negative, we are left wondering whether the intervention is inherently ineffective (either because the intervention was inadequately developed or because all similar interventions are ineffective), whether it was inadequately applied or applied in an inappropriate context, or whether the trial used an inappropriate design, comparison groups or outcomes. If there is a positive effect, it can be hard to judge how the results of the trial might be applied to a different context (box 1)

Coronary heart disease policy models: a systematic review

BACKGROUND: The prevention and treatment of coronary heart disease (CHD) is complex. A variety of models have therefore been developed to try and explain past trends and predict future possibilities. The aim of this systematic review was to evaluate the strengths and limitations of existing CHD policy models. METHODS: A search strategy was developed, piloted and run in MEDLINE and EMBASE electronic databases, supplemented by manually searching reference lists of relevant articles and reviews. Two reviewers independently checked the papers for inclusion and appraisal. All CHD modelling studies were included which addressed a defined population and reported on one or more key outcomes (deaths prevented, life years gained, mortality, incidence, prevalence, disability or cost of treatment). RESULTS: In total, 75 articles describing 42 models were included; 12 (29%) of the 42 models were micro-simulation, 8 (19%) cell-based, and 8 (19%) life table analyses, while 14 (33%) used other modelling methods. Outcomes most commonly reported were cost-effectiveness (36%), numbers of deaths prevented (33%), life-years gained (23%) or CHD incidence (23%). Among the 42 models, 29 (69%) included one or more risk factors for primary prevention, while 8 (19%) just considered CHD treatments. Only 5 (12%) were comprehensive, considering both risk factors and treatments. The six best-developed models are summarised in this paper, all are considered in detail in the appendices. CONCLUSION: Existing CHD policy models vary widely in their depth, breadth, quality, utility and versatility. Few models have been calibrated against observed data, replicated in different settings or adequately validated. Before being accepted as a policy aid, any CHD model should provide an explicit statement of its aims, assumptions, outputs, strengths and limitations