Appeal type: Prescription Drug
Decision: Favorable

We previously issued a favorable reconsideration decision, finding that the Plan was required to provide coverage of Mekinist. Our Physician Reviewer determined that the Plan's criteria for coverage were met. The Plan then requested a reopening on the basis that there was an error in our first review. Specifically, the Plan stated that the requested drug is not being prescribed to treat a medically accepted indication. We reopened this case to address the Plan's argument. We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Mekinist 0.5 mg tablet to be added to a regimen containing Letrozole. Mekinist is requested to be given with Letrozole to treat malignant neoplasm of unspecified ovary (low grade serous ovarian cancer), which is an off-label (non-FDA approved) use.  The enrollee has low grade gynecological cancer and is status post 2 cycles of Carboplatin/Taxol; the prescriber plans to continue Letrozole and add Trametinib (Mekinist) at half dose. A reopening was requested by the Plan. According to the NCCN (National Comprehensive Cancer Network) Drugs & Biologics Compendium states for Mekinist: Ovarian Cancer, Useful in certain circumstances for persistent disease or recurrence of low-grade serous carcinoma. For progression on primary, maintenance, or recurrence therapy.  However, the prescriber plans to continue Letrozole and add Trametinib (Mekinist) at half dose. The Medicare-approved compendia do not contain any citations to support the use of the requested drug in combination with Letrozole, 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 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 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.This decision reverses our previous favorable decision.