Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Revlimid. 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 Revlimid 10 mg; 30/30.The drug is requested to treat acquired von Willebrand syndrome (vWs) and monoclonal gammopathy. The enrollee is an 82 year old man with monoclonal gammopathy and acquired vWs. He has been treated with Cytoxan and Prednisone which is being tapered. On 12/18/19 factor VIII activity was 184%, ristocetin cofactor (vWF activity) was 165%, and vW factor antigen was 171%. On 2/1/20 his monoclonal protein was 0.2 g/dl. On 2/18/20 factor VIII activity was 102%, ristocetin cofactor was 140%, and vW factor antigen was 137%. The prescriber notes he is worried about relapse. He states long term Cyclophosphamide is known to lead to therapy associated myelodysplastic syndrome which can have a poor outcome. The prescriber cites an article from a non-CMS journal which was reviewed and is a report of two cases. The prescriber requests Revlimid to treat him.The use of Revlimid to treat to treat acquired von Willebrand syndrome (vWs) and monoclonal gammopathy is an off-label (non-FDA approved) use. 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 Revlimid 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 Revlimid. 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.