Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lynparza. 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 Lynparza. The drug is requested to treat pancreatic cancer without a germline BRCA mutation, which is an off-label (non-FDA approved) use. The enrollee is a 67 year old woman with metastatic pancreatic cancer involving omentum, nodes and peritoneum. She has been treated with 5FU, Leucovorin, Oxaliplatin, Irinotecan, Gemzar, Abraxane, Onivyde and Keytruda. Her tumor has an ATM mutation suggesting possible response to Lynparza. She is currently on FOLFOX (5FU, Leucovorin, Oxaliplatin). You request Lynparza to be used as maintenance after four to six cycles of FOLFOX to treat her. You cited journal articles in support of the request. The cited articles do not reflect the enrollee's clinical situation. Lynparza is indicated as maintenance after first line platinum based therapy if there is no progression of the cancer and the patient has a germline BRCA mutation. The documentation does not indicate the enrollee has a germline BRCA mutation. In addition, the requested use is after fifth line chemotherapy.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 Lynparza 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 Lynparza. 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.