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 150 mg; 60/30.The drug is requested to treat metastatic pancreatic cancer in a person without a germ line BRCA mutation, which is an off-label (non-FDA approved) use.The enrollee is a 69 year old woman with metastatic pancreatic cancer involving local recurrence and lungs. She was originally treated with surgery and 5FU, Leucovorin, Oxaliplatin, and Irinotecan. She had biopsy proven lung recurrence in 12/2019 and has been treated with Gemcitabine, Cisplatin, and Abraxane. Her CA19-9 has risen from 12,229.8 on 1/8/20 to 16,861.9 on 1/22/20. Guardant360 testing identified a somatic BRCA1 mutation. The prescriber requests Lynparza to treat her.Lynparza is supported for use as maintenance after first line platinum based chemotherapy in patients with deleterious germ line BRCA mutations. The enrollee does not have a germ line BRCA mutation. In addition, the CA19-9 is rising which suggests that she has progression of the cancer and current treatment is not maintenance therapy. Therefore she does not meet the medically supported use.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.