Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Rubraca. 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 Rubraca. The drug is requested to treat metastatic breast cancer, which is an off-label (non-FDA approved) use.The enrollee is a 75 year old woman with metastatic breast cancer involving bones and lymph nodes and stomach. The pathology report dated November 20, 2019 indicates the stomach neoplasm was consistent with metastatic breast cancer. The cancer is hormone receptor positive and HER2 negative. For recurrent, metastatic cancer she has been treated with Anastrozole and Ibrance. A handwritten note indicates she has a BRCA 1 V757fs mutation. You request Rubraca to treat her. Journal citations were submitted in support of the request and were reviewed. The only one that included breast cancer patients treated with the requested drug is Drew et al from the British Journal of Cancer in 2016. Of the 5 patients with breast cancer treated with oral Rucaparib (Rubraca), none had partial or complete response and only 1 had stable disease. Breast cancer is a common disease and the N in this study is very small. In addition, it is not clear that the enrollee's BRCA 1 mutation is a deleterious mutation. In the opinion of this reviewer, this article cannot be used to determine a medically accepted indication.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 Rubraca 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 Rubraca. 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.