Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lenvima. The Plan did not grant this request. We received this case to conduct an independent review. Your appeal also involves Pembrolizumab.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lenvima 20 mg daily dose pack 2 x 10 mg; 60/40.The drug is requested to treat esophageal cancer. The enrollee is a 68 year old man with metastatic esophageal cancer involving lungs and nodes. His cancer is adenocarcinoma and was at the distal esophagus. He has been treated with DFOX (our Reviewer believes this involves Docetaxel, Fluorouracil, Leucovorin and Oxaliplatin.) He has also had radiation with chemotherapy, surgery. He has been on DFOX with neuropathy. As of the office visit did not have progression of the cancer. The prescriber states he worries that the enrollee will become disabled by the neuropathy. He requests Lenvima to be given with Pembrolizumab to treat the enrollee. He cites an article from Lancet Oncology in support of the request. (Lenvatinib plus Pembrolizumab in patients with advanced gastric cancer in the first-line or second-line setting (EPOC1706): an open-label, single-arm, phase 2 trial Akihito Kawazoe, MD et al., Published:June 23, 2020DOI:https://doi.org/10.1016/S1470-2045(20)30271-0). The authors state the conclusion that on the basis of these results, a confirmatory trial will be planned in the future. Therefore the requested treatment is investigational.The use of Lenvima to treat esophageal cancer 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 Lenvima 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 Lenvima. 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.We are dismissing the request for Pembrolizumab. We received your letter asking for an appeal of the Plan's unfavorable determination for Pembrolizumab. Medicare rules do not allow us to review this request until you have completed the appeal process with the Plan. You may request a Reconsideration appeal with us after the Plan issues an unfavorable Redetermination for Pembrolizumab. You may wish to submit this request for Pembrolizumab to the Plan at this time.