ARTICLE | Regulation

Pricing the uncertainty in expedited therapies

How new ideas about pay for performance aim to temper uncertainties, and controversies, about accelerated approvals

September 2, 2021 1:04 PM UTC

Payment systems developed in an age dominated by small molecules for common chronic diseases are not up to the challenge of 21st century medicine. Drugs are increasingly being approved based on new mechanistic understanding of disease, rather than on modifying clinical symptoms or outcomes, and in some cases promise, but have not yet proven, durable functional cures.

Today’s payment systems aren’t able to distinguish between interventions that work well and those that provide marginal benefits, and the lack of infrastructure to support value-based payments, including the inability to track outcomes for individual patients or populations, forces healthcare systems to overpay for marginal treatments and ration access to highly effective medicines. ...