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 25 mg; 21/28. The drug is requested to treat the enrollee's condition, which is an off-label (non-FDA approved) use. The enrollee who presented with neuropathy and cryoglobulinemia. The enrollee has no bone pain. Workup showed a monoclonal gammopathy which increased from 0.5 g/dl to 0.9 g/dl. Bone marrow showed 5% plasma cells. The enrollee hemoglobin is normal. The documentation does not include information about calcium or creatinine levels or any bone imaging. There are two copies of office notes. One was signed and states the diagnosis to be monoclonal gammopathy of undetermined significance.The other note, signed states the diagnosis is multiple myeloma.There is no additional information in the second note or an indication the note was amended.The clinical information does not meet the definition of smoldering or symptomatic multiple myeloma per the NCCN Guidelines Version 3.2021 Multiple Myeloma. The prescriber requests Revlimid to be given with Dexamethasone to treat the enrollee.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.