Session (CTI)

ISSUE: This panel addresses the complexities of interpreting CMS claims data for drug price negotiations under the Inflation Reduction Act, particularly across unique characteristics of classes of products (e.g., chronic vs. acute, Part B vs. Part D, biomarkers and lines of therapy embedded in indications, and combination and regimen use) and the impact on equivalent comparison to therapeutic alternatives . Particularly, panelists will explore the challenges posed by structures and differences in Part B and Part D claims data for identifying and assigning diagnosis, billing units, and days supply. The discussion will focus on challenges and innovative approaches to issues such as estimating days supply for Part B, interpreting therapeutic use of Part D alternatives without claim level diagnosis data, and handling regimen and combination use. Insights will aim to enhance data transparency and accuracy, promoting equitable drug pricing decisions. OVERVIEW: The session will open with a 10-minute overview by moderator Milena Sullivan, who will detail the concerns and implications of how CMS calculates 30-day drug prices, particularly in the context of the structural differences between Part B and Part D claims data and implications for negotiated product manufacturers. This introduction will frame the key challenges, and their impact on CMS negotiation analysis, including negotiated product benchmarks and value comparison to therapeutic alternatives. Following the overview, the moderator will engage the panelists with targeted questions addressing both technical and practical aspects of these challenges. Discussions will explore methodologies for addressing key uncertainties in methodology presented by CMS guidance and availability of information in claims data. The session will also examine the implications for manufacturers navigating CMS pricing processes and strategies for improving data accuracy to support equitable and informed pricing decisions.