The role of imperfect surrogate endpoint information in drug approval and reimbursement decisions

Katalin Bognar, John Romley, Jay P. Bae, James Murray, Jacquelyn W. Chou and Darius Lakdawalla

Journal of Health Economics, 2017, vol. 51, issue C, 1-12

Abstract: Approval of new drugs is increasingly reliant on “surrogate endpoints,” which correlate with but imperfectly predict clinical benefits. Proponents argue surrogate endpoints allow for faster approval, but critics charge they provide inadequate evidence. We develop an economic framework that addresses the value of improvement in the predictive power, or “quality,” of surrogate endpoints, and clarifies how quality can influence decisions by regulators, payers, and manufacturers. For example, the framework shows how lower-quality surrogates lead to greater misalignment of incentives between payers and regulators, resulting in more drugs that are approved for use but not covered by payers. Efficient price-negotiation in the marketplace can help align payer incentives for granting access based on surrogates. Higher-quality surrogates increase manufacturer profits and social surplus from early access to new drugs. Since the return on better quality is shared between manufacturers and payers, private incentives to invest in higher-quality surrogates are inefficiently low.

Keywords: Surrogate endpoints; Drug approval; Drug reimbursement (search for similar items in EconPapers)
Date: 2017
References: View references in EconPapers View complete reference list from CitEc
Citations: View citations in EconPapers (2)

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Persistent link: https://EconPapers.repec.org/RePEc:eee:jhecon:v:51:y:2017:i:c:p:1-12

DOI: 10.1016/j.jhealeco.2016.12.001

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