Defining Specialty Drugs and Upcoming Approvals to Watch | AMCP Annual 2025

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Maria Lowe, Pharm.D., BCPS, associate vice president of pharmaceutical intelligence at the Institute for Clinical and Economic Review, described specialty drugs as high-cost treatments requiring complex handling or disease management and highlighted key upcoming approvals, including a new PCSK9 inhibitor for lipid lowering and tolebrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, which could become the first in its class approved for multiple sclerosis.

Maria Lowe, Ph.D., associate vice president of pharmaceutical intelligence at Institute for Clinical and Economic Review (ICER) addresses the specialty pipeline and some of the near-term products that could be approved. She sat down with Managed Healthcare Executive ahead of the annual meeting of the Academy of Managed Care Pharmacy in Houston.

“There are so many exciting things to watch in the months to come,” she said. “But we are in the midst of a lot of changes that are taking place with the new administration, and we don’t yet know how those changes might affect our drug regulation landscape.

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