Presentation (CTI)

OBJECTIVES: With the application of pharmaceutical tariffs, drug price negotiations, and new mandatory payment models, pharmaceutical manufacturers in the U.S. market face increasing pressures. To better understand the challenges manufacturers face in response to these pressures, we analyzed pharmaceutical manufacturer responses to the Centers for Medicare & Medicaid Service’s (CMS) proposed GLOBE (Global Benchmark for Efficient Drug Pricing) and GUARD (Guarding U.S. Medicare Against Rising Drug Costs) models, identifying common themes and differences in how concerns were framed across the two international reference pricing-based Most-Favored-Nation (MFN) proposals.
METHODS: We conducted a qualitative analysis of comments submitted by 12 of the top U.S. pharmaceutical manufacturers to CMS in response to the proposed GLOBE and GUARD models to identify common themes, including legal authority, innovation and patient access, interactions with existing CMS pricing initiatives, and suggested policy changes. We also performed comparative analyses to examine similarities and differences in how these themes were presented across the two models.
RESULTS: High thematic convergence was observed across manufacturers, with most commenters citing CMS statutory authority, innovation incentives, patient access, and overlap with existing pricing initiatives. However, framing varied: GUARD comments focused more on foreign reference pricing, market distortion, and constitutional challenges, while GLOBE comments highlighted operational complexity and interactions with current CMS demonstrations. Proposed policy solutions also differed, including voluntary pricing commitments, exemptions for orphan or cell and gene therapies, and broader market-based reforms addressing supply chain and reimbursement.
CONCLUSIONS: Pharmaceutical manufacturers demonstrated broad consensus regarding perceived challenges associated with CMS's proposed GUARD and GLOBE models while differing in the legal, innovation, and policy approaches. Characterizing stakeholder framing may provide useful context for evaluating future CMS payment demonstrations and pharmaceutical pricing reforms within an evolving policy landscape. Ongoing discussions about pharmaceutical tariffs, Inflation Reduction Act implementation, and other federal initiatives may shape stakeholder perspectives on drug pricing reform.