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 in a person without germ line BRCA mutation, which is an off-label (non-FDA approved) use.The enrollee is a 67-year-old man with metastatic pancreatic cancer involving liver and lungs. He has been treated with Gemcitabine and Abraxane. He has had a mixed response with some enlarging lung lesions on CT in 12/2019. He required dose reductions and has developed fungal pneumonia. He is not a candidate for further chemotherapy. He has a germline ATM mutation by Ambry Genetics testing. The submitted documents do not indicate he has a germline or suspected germline BRCA mutation. The prescriber states that the ATM mutation is BRCA-like. The prescriber requests Lynparza to treat him. The prescriber cites a study published in the New England J of Medicine (N Engl J Med. 2019 Jul 25;381(4):317-327). The study does not reflect the enrollee's clinical situation.All CMS compendia state the indicated use is for maintenance therapy for patients whose disease has not progressed on chemotherapy. In addition, all compendia state the requirement for deleterious or suspected deleterious germline BRCA mutation.The requested use is for treatment of enlarging lesions. This indicates progression of the cancer. Therefore, the requested use is not for maintenance after response to treatment. In addition, the enrollee does not have a germ line BRCA mutation. Therefore, the requested use in not 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 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.