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In the revised guidance, CMS clarified aspects of the negotiation process and outlined additional opportunities for engagement during the process. CMS will publish by Sept. 1, 2023, the list of the first 10 drugs for price negotiation.

Sarah Emond will continue with ICER’s efforts to assess drug cost-effectiveness and health plan access policies that began with founder Steve Pearson, M.D., who will transition to an advisor role in 2024.

At issue is an ongoing review of inspection results from a third-party filling company. No issues were cited in the FDA’s complete response letter about clinical efficacy or safety.

Now with the name Litfulo, ritlecitinib is the first oral treatment for adolescents with alopecia. It has an annual list price of $49,000.