CMS's Drug Price Negotiation Program 2023 Patient-Focused Listening Sessions: A Descriptive Analysis of Speaker Remarks.

Background: The US Centers for Medicare and Medicaid Services (CMS) held patient-focused listening sessions in Fall 2023 for each of the first ten drugs selected for the Inflation Reduction Act's (IRA) Drug Price Negotiation Program (DPNP). This study aimed to quantitatively describe speaker input at the sessions, including the absolute and relative time allocated to key areas of interest for the DPNP.

Methods: In this descriptive analysis of speaker remarks from ten CMS-hosted patient-focused listening sessions, speaker demographics were examined using video streams, time-stamped transcripts, public data, contextual clues, validated tools, and visual assessment when necessary. Audio recordings were transcribed using a speech-to-text application programming interface, followed by human review for accuracy. Transcripts included speaker identification and sentence-level timestamping. Two researchers coded each sentence into predefined categories on the basis of CMS's optional discussion topics, DPNP goals, and potential unintended consequences of the IRA: speaker background, evidence about selected drugs or therapeutic alternatives, drug prices, patient access/benefit design, therapeutic advancements, and other. The total and proportion of time spent by category were calculated per speaker.

Results: Out of an anticipated 200 speaker slots, 106 total speakers (median per session: 10; range 5-17) and 70 unique speakers participated, most of whom were patients (n = 38, 54.2%), female (n = 40, 57.1%), and below Medicare age (n = 40, 57.1%). The most popular categories discussed included evidence about the selected drug or therapeutic alternatives (median per slot: 36.5% of time; range 0-93.0%) and patient access/benefit design (median per slot: 12.1%; range 0-75.5%). CMS received a median of 12.3 total minutes of evidence about selected drugs or therapeutic alternatives per listening session across all speakers (range per session 3.9-22.6 minutes).

Conclusions: The first listening sessions provided an important, but limited, first step toward patient engagement with the DPNP. Speaker demographics suggest the sessions fell short of capturing the voices of diverse and Medicare-representative patient populations. While speakers often focused their time on patient experience and evidence, CMS received less than 15 minutes of patient-focused evidence about therapeutic alternatives for more than half of the drug listening sessions. CMS has indicated its intent to improve upon the design of the patient-focused listening sessions for drugs selected in the second round of the DPNP. Future iterations should prioritize robust, two-way dialogue, transparency surrounding the impact of patient input on CMS's price determination process, and improvements to event logistics and outreach that facilitate the participation of diverse patients and stakeholders.