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 conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Ibrance. The drug is requested to treat metastatic breast cancer without HER2 status, which is an offlabel(non-FDA approved) use.The enrollee is a 68 year old woman with metastatic breast cancer involving bones and pleura. At the timeof diagnosis in 2010 her tumor was hormone receptor positive and the submitted documentation states shewas apparently HER2 negative. You do not have the details as her care was given in another location. Shewas treated with surgery and adjuvant Adriamycin/Cytoxan followed by Paclitaxel, radiation and 5 years ofAnastrozole. She was diagnosed with metastatic cancer in May 2020. A pathology report datedMay 26, 2020 states tumor cells are positive for all markers including estrogen receptors and they arepositive. The report does not include HER2 test results. The report states a breast prognostic panel will beperformed and reported separately and she has been started on Letrozole. The prescriber requests Ibrance tobe given in combination with Letrozole.The requested use would be first line hormonal treatment for metastatic breast cancer and would be amedically accepted use if her tumor is HER2 negative. However, the HER2 status is not stated. HER2status would be one of the expected prognostic test results to be reported separately from the pathologyreport of May 26, 2020. In response to inquiry requesting those results the report was not submitted.Therefore the HER2 status of the recurrent tumor is not known. The indication for use of Ibrance requiresHER 2 negative status. Therefore there is insufficient information to determine that the requested use is amedically accepted indication.The Medicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted condition. There was no peer-reviewed, clinically relevant, medicalliterature from an approved journal submitted to support this appeal. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. For Part D drugs used in an anticancer chemotherapeutic regimen, a medically acceptedindication means a use that is approved by the FDA or a use that is supported by one or more citations inMedicare approved compendia or peer-reviewed medical literature in CMS-approved journals orpublications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia and there was no peer-reviewed literature from an approved journal submitted tosupport the use of Ibrance for the diagnosed condition. As a result, the drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, it cannot be covered under theMedicare Part D benefit for this condition. An exceptions request based on medical necessity cannot beconsidered 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 paymentcan be made under the Medicare Part D benefit.