Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tafinlar and Mekinist. The Plan did not grant this request. We received this case to conduct an independent review.Tafinlar:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Tafinlar 50 mg; 180 per 30 days. The drug is requested to treat pancreatic cancer, which is an off-label (non-FDA approved) use. The enrollee is a 75 year old man with pancreatic cancer involving nodes and pancreas. He has been treated with 5FU, Leucovorin, Irinotecan, Oxaliplatin, Gemcitabine, Abraxane, and Keytruda. He has decreased appetite and abdominal pain. Foundation One testing shows a BRAF V600E mutation suggesting possible response to Tafinlar. You are requesting Tafinlar to be given with Mekinist to treat him. Journal articles were submitted in support of the request and were reviewed.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 Tafinlar 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 Tafinlar. 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.Mekinist:We are dismissing the request for Mekinist. We received your letter asking for an appeal of the Plan's unfavorable determination for Mekinist. Medicare rules do not allow us to review this case 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. You may wish to submit this request to the Plan at this time.