CMS Says Drugs Approved through FDA Accelerated Approval Must Be Covered

Rare Daily Staff

The Centers for Medicare and Medicaid Services issued a notice to state Medicaid programs saying that drugs approved under the U.S. Food and Drug Administration’s Accelerated Approval pathway must be covered by state Medicaid programs, if the drug meets the definition of “covered outpatient drug.”

CMS said that biologics approved through an accelerated pathway would also fall under the definition of covered outpatient drugs, although vaccines do not.

“As with any other drug, if the drug is labeled by a manufacturer that has signed a Medicaid National Drug Rebate Agreement, and the drug meets the definition of covered outpatient drug, then the drug is covered by the Medicaid Drug Rebate Program (MDRP) and is to be covered by state Medicaid programs,” Michael Nardone, director disabled and elderly health programs group for CMS, said in the notice.

The notice said states can use utilization management mechanisms, such as prior authorization, to assure appropriate use of these medications.

The National Organization for Rare Disorders praised the CMS notice.

“In today’s notice, CMS reaffirmed that medications approved through FDA’s Accelerated Approval Program must be accessible to patients in the Medicaid program because these therapies are covered under existing Medicaid Drug Rebate agreements,” NORD said. “Without the Accelerated Approval Program, many individuals with rare diseases would be left with few, if any, treatments because traditional clinical trials would be nearly impossible to conduct. NORD believes it is crucial that FDA continue to utilize these tools, and CMS continue to support access to these therapies once approved.”

June 27, 2018
Photo: Michael Nardone, director of disabled and elderly health programs group for CMS