On Aug. 29, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited list of the first 10 Part D drugs to be included in the new Medicare Price Negotiation process. The 10 drugs represent $50.5 billion, or 20% of the total gross spend on prescription drugs in the Medicare Part D program from June 2022–May 2023. The list includes the commonly prescribed drugs Jardiance, Eliquis, Xarelto, Januvia and—most importantly for patients suffering from rheumatic diseases—Enbrel and Stelara.
The Initial List
The list was determined following the publication of initial guidance and revised guidance documents outlining the inclusion criteria, specifically the definition of “qualifying single-source drugs.” The criteria include the following:
- Seven years have passed since the FDA approved a drug as of Sept. 1, 2023.
- Eleven years have passed since the FDA issued a biologic license as of Sept. 1, 2023.
- The drug or biologic product is not listed as a reference product for a generic drug or biosimilar.
As of Oct. 3, all 10 manufacturers had signed agreements with the CMS to enter negotiations and submitted initial data to inform discussions with the FDA throughout the fall. By February 2024, the CMS will provide an initial proposal for the maximum fair price of each drug and will allow each manufacturer to provide a counteroffer. Should continued disagreement continue, the manufacturer and the CMS will engage in three negotiating sessions in the spring and summer of 2024. The final maximum fair price list will be published by Sept. 1, 2024, for implementation in 2026.
The CMS has encouraged stakeholder engagement throughout the process, particularly from the patient community. The ACR provided comments to the CMS regarding its implementation of the negotiation program. Listening sessions on each listed drug will occur during the fall. The ACR will continue to be engaged and looks forward to continuing our participation throughout the process.