Protected Class Policy for AEDs Maintained in Medicare Part D Final Rule

On May 16, 2019 the Centers for Medicare and Medicaid Services (CMS) published its final rule on Medicare Advantage and Part D Drug Pricing. The final rule did not move forward on CMS’ proposals made earlier this year to weaken the current policies under Medicare Part D for the protected classes of drugs, which include anticonvulsants. The final rule codifies the existing policy that permits Part D plans to impose prior authorization and step therapy requirements only for patients initiating treatment (i.e., new starts), but does not allow Part D plans to impose these utilization management tools with patients already on anticonvulsant medications. In addition, the rule did not finalize the proposals to exclude a protected class drug from a formulary for a price increase above a certain threshold or if the drug represents a new formulation of an existing single source drug.

NAEC submitted a comment letter in opposition to the proposed rule in January and joined many epilepsy organizations in signing a group letter making similar arguments. NAEC argued that the current protected class policies for anticonvulsants be maintained, since so many individuals with epilepsy do not respond to a single drug and an unrestricted formulary providing multiple medication options with novel mechanisms of action and side effect profiles is essential to control seizures and minimize side-effects.