Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Revlimid, 10 mg capsule. 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.The drug is requested to treat cutaneous plasmacytosis, which is an off-label (non-FDA approved) use. The enrollee is a 70 year old woman with cutaneous plasmacytosis with extensive and progressive skin involvement of the face, trunk and extremities. It involves approximately 90% of her body surface area. Biopsy found a monoclonal plasma cell infiltrate and states the differential diagnosis includes marginal zone lymphoma, plasmacytic variant, plasmacytoma, or cutaneous extension of a plasma cell dyscrasia. It has been refractory to unspecified treatments. No other clinical information was submitted for review. The prescriber states this is a rare disease. The prescriber requests Revlimid to treat her. Journal articles were submitted in support of the request and were reviewed.Although cutaneous plasmacytosis is not included in the NCCN cancer guidelines for plasma cell disorders, nor is it listed in the non-melanoma skin cancers, in the opinion of this reviewer, the pathologic finding of monoclonal plasma cells indicates that the condition is a type of cancer. Therefore this review was done using the Medicare rules for cancer drugs.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. This reviewer did not find any supporting citations in a PubMed search. 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, 10 mg capsule 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, 10 mg capsule. 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.