As pharmaceutical leaders navigate IRA price negotiation, significant uncertainties remain about how policies will unfold. In this discussion, four regulatory and policy experts address the defining challenges facing pharma strategy—from CMS implementation of negotiated drug prices to how policy changes may affect physician practice economics and global launch decisions.
Negotiated drug prices have become more predictable once a drug is selected, but actual price levels continue to trend downward year over year. A focal point of the discussion is biosimilar policy. Kirsten Axelsen, DLA Piper, highlights Stellara biosimilars that cost less and offer lower copays than the innovator’s maximum fair price, yet lack formulary coverage. Reconsidering what excludes biologics from price negotiation is identified as a potential reform that could improve patient access while maintaining innovation incentives.
The broader challenge: pharmaceutical executives are making long-term strategic decisions today—on which markets to prioritize, where to manufacture, how to structure portfolios—against a backdrop of policy uncertainty heading into the midterm elections. Axelsen emphasizes that which policies will ultimately advance or be reversed remains highly uncertain.