Between October 30 and November 15, 2023, the Centers for Medicare and Medicaid Services (CMS) hosted patient-focused listening sessions as part of the Medicare Drug Price Negotiation Program for the selected drugs Eliquis, Enbrel, Entresto, Farxiga, NovoLog/Fiasp, Imbruvica, Januvia, Jardiance, Stelara, and Xarelto. CMS expected to randomly select about twenty speakers from registrants for each Listening Session, however, participation throughout the sessions was low. Sessions had an average of ten participants, and some participants were selected to speak at multiple sessions.

Sessions included discussion of disease burden/drug benefit and unique patient considerations, cost concerns, pharmacy benefit manager (PBM) and plan concerns, and consequences of negotiation. Notably, participants repeatedly asked about CMS’ patient engagement process throughout the negotiation program and whether CMS considered the selected speakers’ potential conflicts of interest.

Cost Concerns

Speakers in all ten sessions discussed patients’ need for lower cost prescription drugs, stating that the high cost of some medications cause patients to split pills or skip doses altogether. Some participants noted their prescription costs were affordable while enrolled in commercial insurance, due patient assistance programs, but that cost became a pressing concern after enrolling in Medicare as many of the programs are not permitted.

Disease Burden/Drug Benefit and Unique Patient Considerations

Participants noted that all ten selected drugs have greatly benefited patients and their caretakers’ quality of life, ranging from eliminating the need for multiple follow-up appointments due to side effects to reduced safety risks and dietary restrictions. Speakers also highlighted the unique burden that cost and access have on people of color. Specifically, speakers were focused on the fact that half of the selected drugs treat cardiovascular conditions – something that disproportionately affects Black Americans. Speakers were therefore hopeful that CMS would work with the Office of Minority Health during the negotiation process to ensure that people of color do not lose access to life-saving medications and in turn, further increase racial disparities.

PBM and Plan Concerns

Speakers shared concerns about the unintended consequences negotiation may have across the healthcare ecosystem, including PBMs implementing utilization management or negative formulary changes (e.g., moving a product to a higher tier) for negotiated drugs and/or non-negotiated competitors. Speakers urged CMS to establish protections to ensure stringent utilization management practices are not implemented due to the IRA.

Consequences of Negotiation

While speakers were supportive of the goal behind the negotiation process, to lower drug costs, they were concerned that these drugs were selected, not because of their high prices, but because of their high spend due to high utilization. Speakers were also concerned that negotiation could inhibit innovation by discouraging new drug development and trials for additional rare disease indications. Given CMS’ aggregation policy (by active moiety/ingredient), speakers recommended the agency consider secondary indications when establishing prices.

Next Steps

CMS will be making offers to manufacturers of selected drugs in February 2024, and the negotiation period will end August 1, 2024. CMS will publish the negotiated maximum fair prices for the selected drugs by September 1, 2024. Maximum fair prices for these drugs will become effective January 1, 2026.

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