FDA withdrawal of Makena
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 — CarePartners of Connecticut will not authorize any prior authorization requests for new starts. 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.
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.