The Food and Drug Administration’s (FDA’s) looming decision over whether to pull the preterm birth drug Makena (hydroxyprogesterone caproate) has reignited debate over their accelerated approval program, and the potential need for more “teeth” in policies by which regulators can remove ineffective drugs from the marketplace. Payers also wrestle with drugs approved under the accelerated approval program, designed to “allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint.” We examined US commercial payers’ coverage policies for Makena, and whether and how payer behavior changed as the evidence base for the drug evolved.
