Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Afinitor (Everolimus). 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 Afinitor (Everolimus). The drug is requested to treat metastatic breast cancer in combination with Femara (Letrozole), which is an off-label (non-FDA approved) use.The enrollee is a 73 year old woman with metastatic breast cancer involving bones, liver and axilla. Her cancer is estrogen receptor positive and HER2 negative. She has been treated with surgery, radiation, Cytoxan, Adriamycin, 5FU, Tamoxifen, and Femara. After relapse in the axilla she has been treated with radiation, Xeloda, Taxotere, Cytoxan, Aromasin, Faslodex, Abraxane, Evista, Kisqali, and Ibrance. She had progression of the cancer and was started on Afinitor with Femara in February 2019 with good results. You request Afinitor to be continued in combination with Femara. You state the enrollee does not tolerate Aromasin (Exemestane) and has had prior Tamoxifen and Faslodex so Femara is the preferred hormonal agent. You cite Bolero-2 and Bolero-4 trials in support of the request. Bolero-2 (N Engl J Med. 2012 Feb 9;366(6):520-9) relates to the combination of Everolimus and Exemestane, not Femara. In Bolero-4 (JAMA Oncol. 2018 Jul 1;4(7):977-984) patients with prior systemic treatment, including hormonal treatment, for advanced disease were excluded. Therefore the studies do not reflect the enrollee's clinical situation.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 Afinitor (Everolimus) 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 Afinitor (Everolimus). 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.