Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xiaflex 0.9 mg 2 vials/28 days. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Xiaflex 0.9 mg 2 vials/28 days.The drug is requested to treat Peyronie's disease in an enrollee who has previously completed 10 Xiaflexinjections, which is an off-label (non-FDA approved) use. The product label, available at drugs@fda,states: A treatment course consists of a maximum of 4 treatment cycles. Each treatment cycle consists oftwo XIAFLEX injection procedures. The safety of more than one treatment course of XIAFLEX is notknown. The prescriber stated on 8/17/2020 that the enrollee has already had, 10 injections. TheMedicare-approved compendia do not support the use of this drug for treatment of the noted condition dueto serious safety concerns. Therefore, this drug is not being prescribed for a medically accepted indicationas defined by Medicare law. As such, an exceptions request based on medical necessity cannot beconsidered because the requested drug, as prescribed, does not meet the definition of a Medicare Part Ddrug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.Medicare rules state that a Part D plan may exclude from coverage any Part D drug that is not medicallyreasonable and necessary to treat the enrollee's condition. The Part D Plan conducts drug use reviews forenrollees to help make sure that they are getting safe and appropriate care. During these reviews, the Planlooks for potential problems such as drugs that may not be necessary because the enrollee is taking anotherdrug to treat the same medical condition, drugs that may not be safe or appropriate due to the enrollee's ageor gender, or certain combinations of drugs that could harm the enrollee if taken at the same time.We sent this case to our Physician Reviewer to determine whether the Part D Plan was correct in denyingcoverage for Xiaflex 0.9 mg 2 vials/28 days. Based on the information available in the case record, ourPhysician Reviewer determined that the use of Xiaflex 0.9 mg 2 vials/28 days in this case is not medicallyreasonable and necessary. Therefore, our decision is that the Part D Plan is not required to provide coveragefor Xiaflex 0.9 mg 2 vials/28 days.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Xiaflex 0.9 mg 2 vials/28 days for the diagnosed condition. Asa result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law.As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Xiaflex 0.9 mg 2 vials/28 days.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.