Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tafinlar, 75 mg capsule. 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 Tafinlar 75 mg; 120/30 and added at time of appeal, Mekinist 2 mg; 30/30.The drug is requested to treat relapsed ovarian/primary peritoneal cancer, which is an off-label (non-FDA approved) use. The enrollee is a 63 year old woman with a history of appendiceal and breast cancers who has relapsed ovarian/primary peritoneal cancer involving omentum and abdominal soft tissue. At the time of original diagnosis, she had surgery and chemotherapy with Carboplatin/Taxol. The tumor is BRAF V600E mutation positive. The prescriber requests Tafinlar to be given with Mekinist to treat her. The office note states there are IV chemotherapy options.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 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, 75 mg capsule 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, 75 mg capsule.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.Please note, a request for Mekinist has been added at the reconsideration level. Medicare rules do not allow us to review this case until you have completed the appeal process with the Plan for Mekinist. If you require a coverage review for Mekinist, you may wish to submit a request to the Plan at this time.