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 15 mg; 21 per 28 days. The drug is requested to treat relapsed marginal zone lymphoma in combination with Gazyva, which is an off-label (non-FDA approved) use. The enrollee is a 75 year old woman with relapsed marginal zone lymphoma involving bowel wall and iliac lymph nodes. She has been treated with radiation, Rituxan, R-CHOP (Rituxan, Cytoxan, Vincristine, Prednisone) for transformation to diffuse large B-Cell lymphoma with complete remission, Bendamustine/Rituximab for recurrence of her low grade lymphoma, and Acalabrutinib on a clinical trial for evidence of extranodal marginal zone lymphoma. The PET scan shows progression of the disease. You are requesting Revlimid to be given with Gazyva to treat her. An abstract from 2015 and journal articles were submitted in support of the request. Abstracts cannot be used to determine medically accepted use. The article from Lancet Haematology 7/201 by Morschhauser et al was not specifically for marginal zone lymphoma and concludes that randomized trials are needed. Therefore the requested combination is investigational. The article by Leonard from Journal of Clinical Oncology 2019 May 10;37(14):1188-1199 relates to the use of the drug in combination with Rituximab and does not reflect the enrollee's clinical situation.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.