Negative Makena Confirmatory Data Didn’t Affect Reimbursement

May 3, 2023

Negative confirmatory data for the preterm birth drug Makena did not affect payers’ decisions to reimburse the drug, according to an analysis published in Health Affairs Forefront. The drug was granted accelerated approval by the US Food and Drug Administration (FDA) back in 2011 based on a small sample size. It was then recommended to be pulled from the market last October by the FDA Center for Drug Evaluation and Research advisory committee based on larger pools of post-market data showing no reduction in pre-term births. The agency finalized Makena’s approval withdrawal in early April this year.

According to the authors, “As of August 2022, coverage policies were publicly available for 16 payers in SPEC. All 16 have covered the drug in a manner consistent with the FDA label indication. That is, no plans have imposed clinical restrictions on coverage or required patients to be ineligible for alternative treatments, before being eligible for Makena, though one plan required that the drug be prescribed by an obstetrician. Coverage remained consistent from 2016-2022, despite the availability of data from the negative confirmatory clinical trial in 2019.”

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