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.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lenvima. The drug is requested to treat rectal cancer which is an off-label (non-FDA approved) use.The enrollee is a 74-year-old man with metastatic rectal cancer involving liver and bone. His tumor is MSI-stable, and KRAS, NRAS, and BRAF wild-type by next generation sequencing. He has been treated with FOLFOX-Avastin (5FU, Oxaliplatin, Leucovorin and Avastin), Xeloda, radiation, microwave ablation, FOLFIRI + Erbitux (5FU, Irinotecan, Leucovorin) and Y-90. Imaging in November 2020 showed progression in the liver. Options were discussed including repeat FOLFOX-Avastin, Stivarga or Lonsurf as well as Lenvima/Pembrolizumab. The prescriber requests Lenvima to be given with Pembrolizumab to treat him. The prescriber submitted an abstract from the 2020 European Society of Medical Oncology meetings regarding the LEEP-005 trial in support of the request. The trial was phase II and included only 32 colorectal patients. The abstract notes the trial is ongoing. Therefore, the requested use is investigational.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.