In this article, authors Ashley Jaksa (VP, Scientific Strategy & Partnerships, Aetion) and Patrick Arena (Director, Scientific Strategy, Aetion) walk us through the process through which CMS is negotiating drug prices for 10 high-cost Medicare drugs using a statutorily mandated price ceiling and adjusting for various criteria to determine a "maximum fair price" (MFP). They discuss how CMS plans to incorporate real-world evidence (RWE) from comparative effectiveness studies to understand therapeutic alternatives and make informed decisions, learning from the practices of international health technology assessment agencies. The authors advise that to enhance the negotiation process, CMS should develop clear standards for RWE study quality, invest in improving data infrastructure, and ensure high-quality, accessible real-world data (RWD) to support robust evidence generation.
