Back to Insights and Updates for ProvidersMay 2023

FDA withdrawal of Makena

All products

As a result of the Food and Drug Administration’s (FDA) decision on April 6 to withdraw approval of Makena (hydroxyprogesterone caproate) — both the brand name and generic injection — Point32Health will not authorize any prior authorization requests for new starts for Commercial, Tufts Health Direct, and Tufts Health RITogether members. Providers may request continuation of therapy for the compounded formulation, which requires prior authorization, if medical necessity is met. Please be aware, however, that as of July 1, 2023, we will no longer provide reimbursement for brand name Makena or the generic or compounded formulation.

As part of the MassHealth Unified Formulary, Tufts Health Together will follow MassHealth’s coverage. Effective immediately, requests for new and existing Tufts Health Together utilizers will be reviewed against the criteria for non-FDA approved drugs and biologics. Requests for the compound will be reviewed for medical necessity for members currently being treated with brand or generic Makena.

In its decision to withdraw approval, the FDA stated that Makena was no longer deemed effective at reducing the risk of early birth in women with a history of spontaneous preterm birth.

Audrey Kleinberg,
Director, Provider Relations & Communications

Annmarie Dadoly,
Senior Manager, Provider Communications

Joseph O’Riordan, Jesse Salvato, Stephen Wong,

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Production Coordinator

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Graphic Designer