Coverage of Makena (17-Alpha Hydroxyprogesterone Caproate) for Prevention of Pre-Term Birth (IB 23-8)

Date: 05/01/23

Louisiana Healthcare Connections is sharing with providers that the U.S. Food and Drug Administration has withdrawn approval of Makena. Louisiana Healthcare Connections will no long cover Makena and its generics. Information Bulletin 23-8: Coverage of Makena (17-Alpha Hydroxyprogesterone Caproate) for Prevention of Pre-Term Birth is detailed below.

On April 6, 2023, the U.S. Food and Drug Administration (FDA) withdrew approval of Makena, effective immediately, due to lack of evidence that it reduces the risk of recurrent spontaneous preterm birth (PTB). This decision applies to both brand name (Makena) and generic versions of the medication. 

The drug had been approved under the accelerated approval pathway to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. The decision was issued jointly by the FDA Commissioner and Chief Scientist. 

Approvals of these drugs have been withdrawn because the drugs are no longer shown to be effective and the benefits do not outweigh the risks for the indication for which they were approved. For additional information, see Makena Information on FDA.gov. 

Effective April 6, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce, and they are no longer covered by Louisiana Medicaid.