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.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Tafainlar 75 mg; 120/30 and Mekinist 2 mg; 30/30.The drugs are requested to treat intrahepatic cholangiocarcinoma. The enrollee is an 80 year old man with metastatic intrahepatic cholangiocarcinoma involving nodes, liver, and lungs. He has been treated with Cisplatin and Gemcitabine. Foundation One CDx showed a BRAF V600K mutation suggesting possible response to the two requested drugs. The prescriber requests Tafinlar and Mekinist to treat him.The prescriber states the other treatment option has low response rate and survival duration. The prescriber states without access to these drugs the enrollee's life is likely to be significantly shortened, with a high risk of death within the next few months. The prescriber cites an abstract from the Journal of Clinical Oncology by Wainberg et al. Abstracts cannot be used to determine medically accepted use and in this case does not reflect the enrollee's clinical situation as it relates to BRAF V600E mutations.The use of the requested drugs to treat intrahepatic cholangiocarcinoma is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drugs, 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 drugs are 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 drugs are 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 inMedicare 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 and Mekinist 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 and Mekinist. 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.