John M. O’Brien, Jan Elias Hansen
Value in Health, December 2023
In the December 2023 issue of Value in Health, Drs. O'Brien and Hansen offer considerations for CMS on the implementation of the Inflation Reduction Act's Medicare Drug Price Negotiation Program. They outline concerns over CMS’s ambiguous standards, along with the agency's intent to incorporate nonclinical factors unrelated to product value, such as manufacturing costs. The authors warn that these approaches threaten to artificially suppress negotiated prices below fair value and urge more scientific clarity and rigor in the agency’s process, to avoid hindering patient access and the continued development of new treatments, especially in oncology and rare diseases.