Cost effectiveness analysis of a fixed dose combination pill for primary prevention of cardiovascular disease from an individual participant data meta-analysis.

Background: Cardiovascular disease (CVD) continues to impart a large burden on the global population, especially in lower income countries where affordability limits the use of cardiovascular medicines. A fixed dose combination strategy of at least 2 blood pressure lowering medications and a statin with aspirin in a single pill has been shown to reduce the risk of incident CVD by 38% in primary prevention in a recent meta-analysis. We report the in-trial (median follow-up: 5 years) cost-effectiveness of a fixed dose combination (FDC) pill in different income groups based on data from that meta-analysis.
Methods: Countries were categorized using World Bank economic groups: Lower Middle Income Countries (LMIC), Upper Middle Income Countries (UMIC) and High Income Countries (HIC). Country specific costs were obtained for hospitalized events, procedures, and non-study medications (2020 USD). FDC price was based on the cheapest equivalent substitute (CES) for each component.
Findings: For the CES-FDC pill versus control the difference in cost was $346 (95% CI: $294-$398) per participant in Lower Middle Income Countries, $838 (95% CI: $781-$895) in Upper Middle Income Countries and $42 (95% CI: -$155 to $239) (cost-neutral) in High Income Countries. During the study period the CES-FDC pill was associated with incremental gain in quality-adjusted life years of 0.06 (95% CI: 0.04-0.08) resulting in an incremental cost-effectiveness ratio (ICER) of $5767 (95% CI: 5735-$5799), $13,937 (95% CI: $13,893-$14,041) and $700 (95% CI: $662-$738) respectively. In subgroups analyses, the highest 10 years CVD risk subgroup had ICERs of $2033, $7322 and -$6000/QALY.
Interpretation: A FDC pill produced at CES costs is cost-neutral in HIC. Governments of LMI and UMI countries should assess these results based on the ICER threshold accepted in their own country and own specific health care priorities but should consider prioritizing this strategy for patients with high 10 years CVD risk as a first step.
Funding: Population Health Research Institute.
Competing Interests: AL, WT, PJ, PG, RM, GR, PL-J, PP, AA, AD and HG have no conflicts to declare. MDH reports Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events outside the submitted work from PwC Switzerland. Support for attending meetings and/or travel outside the submitted work from the World Heart Federation. MDH has an appointment at The George Institute for Global Health, which has a patent, license, and has received investment funding with intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines and has patents pending for Heart Failure polypills. DX reports grants from Population Health Research Institute, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Coca-Cola India, the Indian Council of Medical Research, Pfizer, UK Medical Research Council, and Wellcome Trust outside the submitted work. Speaker's fees from Eli Lilly, Sanofi and Intas outside the submitted work. Support for attending meetings and/or travel outside the submitted work from the Indian Council of Medical Research, Eli Lilly, Sanofi, BIRAC and DBC. DX is an honorary VP with SOCHARA and honorary executive committee member of ISCR. SY reports grants from AstraZeneca, and Cadila Pharmaceuticals related to conducting the HOPE-3 or TIPS-3 studies and Honoraria for lectures on the Prevention of Cardiovascular Disease from diverse sources.
(© 2024 The Author(s).)