The Imperative to Enhance Cost-Effectiveness for Cardiovascular Therapeutic Development.

Cardiovascular disease (CVD) is the leading cause of mortality worldwide. Therapeutic agents, such as those that lower low-density lipoprotein cholesterol, have been a critical factor in mitigating CVD event risk and demonstrate the important role that drug discovery plays in reducing morbidity and mortality. However, rapidly rising development costs, diminishing returns, and an increasingly challenging regulatory environment have all contributed to a declining number of cardiovascular (CV) therapeutic agents entering the health care marketplace. For pharmaceutical companies, a traditional cardiovascular outcomes trial (CVOT) can be a major financial burden and impediment to CV agent development. They can take as long as a decade to conduct, delaying potential investment return while carrying risk of failure. For patients, lengthy CVOTs delay drug accessibility. Without cost-effective CVOTs, drug innovation may be compromised, with CV patients bearing the consequences. This paper reviews potential approaches for making CV drug development more cost-effective.
Competing Interests: Dr Davidson is the Chief Executive Officer of NewAmsterdam Pharma and holds stock or stock options. Dr Hsieh is the Executive Director of Research and Development of NewAmsterdam Pharma and holds stock or stock options. Drs Ducjkub abd Naju are employees of Midwest Biomedical Research, which has received consulting fees and grant funding from NewAmsterdam Pharma, Acasti Pharma, Beren Therapeutics, Eli Lilly and Company, Indiana University and Foundation, Matinas BioPharma, NorthSea Therapeutics, and 89Bio.
(© 2024 The Authors.)