Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover 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 Mekinist. The drug is requested to treat spindle cell sarcoma, which is an off-label (non-FDA approved) use.The enrollee is a 54 year old woman with recurrent, metastatic spindle cell sarcoma involving her head, lungs, liver and bones. She has been treated with surgery, radiation/Cisplatin, Taxotere/Gemzar, Votrient, Piqray, Nivolumab,and Ipilimumab. She has been on Votrient plus Piqray but not tolerating it. You request Mekinist to be given with Votrient to treat her.A journal article (Clinical Cancer Research. 2017; 23 (15): 4027-4034) was submitted in support of the request and was reviewed. The study showed the four month survival was not an improvement over the hypothesized null four month progression free survival and a partial response occurred in only two of the twenty-five patients enrolled. The conclusion was that the combination was tolerable without indication of added activity of the combination. Therefore in the opinion of this reviewer the article does not support that the requested combination is a medically accepted use.Of note is that the prior authorization form and faxed at 8:13 AM indicates the enrollee has melanoma. The medical records do not include any indication of that diagnosis.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 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.