OBJECTIVES: The Centers for Medicare and Medicaid Services (CMS) held Patient-Focused Listening Sessions in Fall 2023 for each of the first 10 drugs selected for the Drug Price Negotiation Program established by the Inflation Reduction Act (IRA). This study aimed to describe the breadth of patient and stakeholder input at the sessions.

METHODS: In this content analysis, data were extracted from each session’s video stream and audio transcriptions with timestamps (created by AssemblyAI). Two researchers categorized each speech segment into predefined themes: 1) Speaker background, 2) Evidence about therapeutic alternatives (e.g., patient experience, comparative effectiveness), 3) Drug prices, 4) Patient access/benefit design, 5) Innovation, and 6) Other. The total and proportion of time spent by theme were calculated for each speaker. Speaker demographics and types (i.e., patient, representative of patient advocacy organization, healthcare provider, and other) were recorded.

RESULTS: 106 speakers participated across 10 listening sessions (mean speakers per session: 10.6; range: 5-17). Speakers were most often representatives of patient advocacy organizations (43.4%) and patients (35.8%) and were primarily white (87.7%), female (55.7%), and below the age of 65 (63.2%). The themes discussed for the greatest proportion of speaker time included evidence about therapeutic alternatives (39.8%) and patient access/benefit design (19.2%). Even as the most emphasized theme, given the limited number of speakers and time allotted, CMS received, on average, only 13.2 minutes of input on patient-focused evidence about therapeutic alternatives per drug (range per session: 3.85-22.6).

CONCLUSIONS: Though speakers often focused their time on patient experience and evidence, the passive listening format provided CMS, on average, with less than 15 minutes of patient-focused input per session on this critical aspect of drug evaluation. Speaker demographics suggest the sessions fell short of capturing voices of diverse and Medicare-specific patient populations. Speakers’ focus on patient access emphasized concerns about the unintended consequences of the IRA.