Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xpovio. 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 Xpovio. The drug is requested to treat multiple myeloma not refractory to 2 proteasome inhibitors, which is an off-label (non-FDA approved) use.The enrollee is a 64-year-old man with multiple myeloma who has been treated with Velcade, Revlimid, Dexamethasone, stem cell transplant with Melphalan, Daratumumab, and Pomalyst. He has minimal symptoms. His total protein has risen from 7.5 on 2/17/20 to 8.8 on 3/30/20 and beta-2 microglobulin from 2.89 to 3.4 on those same dates. The prescriber states he has clear laboratory evidence of progression on third line therapy. The option of Carfilzomib was discussed. The enrollee and the prescriber are concerned about the enrollee's risk of COVID-19 and prefer to use an all oral treatment that avoids clinic visits. The prescriber requests Xpovio to treat him in combination with Dexamethasone.Xpovio is approved and supported for patients who have d in combination with Dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti CD38 monoclonal antibody. The enrollee has only been treated with one proteasome inhibitor. The prescriber considers a second one, Carfilzomib to be a treatment option. Therefore, the treatment requested is not a medically accepted indication.The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. For Part D drugs used in an anticancer chemotherapeutic regimen, a medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia or peer-reviewed medical literature in CMS-approved journals or publications. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Xpovio for the diagnosed condition. As a 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 request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Xpovio. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.