Economic Data Show Cost-Effectiveness of Statin, Antihypertensive Polypill for CVD in Low-Income Populations

Although the polypill is comprised of generic, off-patent components, no pharmaceutical company has invested the resources needed to secure FDA approval.

Image Credit: Denira-stock.adobe.com

New data demonstrated that a cardiovascular polypill—combining a statin with 3 half-standard dose antihypertensive medications—offers a cost-effective solution for managing cardiovascular disease (CVD) in majority Black and low-income populations.¹ The findings show significant potential for addressing health disparities.

CVD disproportionately burdens Black and low-income populations compared with White and high-income populations.² Previous research has shown that while wealthier individuals experienced declines in angina, heart attacks, and heart failure, these issues either did not improve or worsened for those with fewer resources.

Aiming to address this disparity, the researchers of the new study utilized a computer simulation model to compare the polypill's cost-effectiveness against usual care.¹ The investigation was derived from an economic evaluation of 100,000 individuals representing the Southern Community Cohort Study (SCCS) Polypill Trial population.

The cohort was probabilistically sampled from 3720 individuals in the National Health and Nutrition Examination Survey. The primary outcomes included direct health care costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios, all analyzed from a health care sector perspective over a 10-year horizon.

Researchers used a computer simulation model to project the health and economic outcomes of polypill use over a decade. The analysis projected that polypill treatment would cost $463 per year and remain a high-value intervention, with cost-saving potential if priced at $443 or less annually. By reducing the number of physician visits, attributed to better blood pressure control among patients, the polypill could significantly decrease overall health care costs.

The projections indicate that polypill treatment would cost $8560 per QALY gained, which falls within the threshold for high-value care, defined as being under $50,000 per QALY gained. In 99% of simulations, the intervention met this high-value criterion. The treatment can be considered cost-saving if its annual price is $443 or less, and it remains high value at an annual cost of $559 or less, according to the study.

In a secondary analysis focusing on an estimated 3.6 million non-Hispanic Black adults eligible for the trial, the polypill continued to demonstrate high value, with a cost of $13,400 per QALY gained. Additionally, the health equity impact of the polypill is significant; by effectively controlling CVD risk factors in populations with limited health care access, the polypill has the potential to reduce income- and race-related health disparities.

Because these individuals often face lower adherence to preventive medications due to economic and systemic barriers, the researchers emphasized the simplified regimen offered by the polypill, potentially improving adherence and delivering particular benefits to groups with historically low persistence in cardiovascular care. While this study centered on low-income, majority Black populations, researchers suggest the polypill could similarly benefit other underserved groups, including community-dwelling older adults and younger individuals with elevated CVD risks.

Although the polypill is comprised of generic, off-patent components, no pharmaceutical company has invested the resources needed to secure FDA approval. Researchers estimated that a polypill priced at less than $1.50 per day could be profitable and sustainable, creating an opportunity for industry engagement.

Additionally, the Inflation Reduction Act (2022) allows Medicare to negotiate prices for certain brand-name medications, but the polypill’s generic status excludes it from such negotiations. The researchers suggested that policymakers consider expanding this remit to include interventions like the polypill, given its potential to reduce health care disparities alongside its cost-effectiveness.

"The value of fulfilling the health equity goal of reduced disparities in CVD should be considered alongside standard measures of cost-effectiveness," the researchers wrote.

References

1. Kohli-Lynch CN, Moran AE, Kazi DS, et al. Cost-Effectiveness of a polypill for cardiovascular disease prevention in an underserved population. JAMA Cardiol. Published online January 08, 2025. doi:10.1001/jamacardio.2024.4812

2. Abdalla SM, Yu S, Galea S. Trends in cardiovascular disease prevalence by income level in the United States. JAMA Netw Open. 2020;3(9):e2018150. doi:10.1001/jamanetworkopen.2020.18150