Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ibrance. 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 Ibrance. The drug is requested to treat the endometrial cancer which is an off-label (non-FDA approved) use. The enrollee is a 77 year old woman with a past history of breast cancer and active endometrial carcinosarcoma cancer. There are enlarged mediastinal nodes, multiple small bilateral pulmonary nodules, a possible T6 vertebral lesion and enlarged external iliac nodes. She has been on Tamoxifen. The office notes of December 2019 indicate she has stage IV endometrial cancer and it is too late for radiation. The only therapy she received is epigenetic therapy. Circulating tumor DNA is positive for PI3K, CCK, and TP53, ARID1 and APC. Pathology revealed TP53 mutation and no mismatch repair deficiency. The appeal dated January 21, 20 and January 28, 2020 indicates the enrollee has breast cancer and metastatic cancer to lung and current active endometrial cancer. The prior authorization form dated January 21, 2010 indicates she has endometrial cancer and that she has advanced or metastatic hormone receptor positive disease and does not have human epidermal growth factor receptor 2 negative breast cancer. The prescriber requests Ibrance to be given with Letrozole and Afinitor to treat her. 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 Ibrance 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 Ibrance. 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.