Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.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 ovarian cancer as monotherapy without a germline BRCA mutation, which is an off-label (non-FDA approved) use.The enrollee is a 70-year-old woman with ovarian cancer involving the omentum, peritoneum and diaphragm. She has been treated with surgery, Carboplatin, Taxol, Liposomal Doxorubicin, and Bevacizumab. She has had 3 lines of chemotherapy. Her CA125 was 98 on 2/18/20. Tumor genomics showed HRD genomic instability positive. Tumor mutation BRCA 1 and 2 negative. Genetics testing showed a variant of uncertain significance and she was negative for 82 other genes through Invitae Laboratory Multi-cancer panel. The prescriber requests Lynparza to treat her.Lynparza is indicated as monotherapy after 3 or more lines of chemotherapy and there is persistent or recurrent ovarian cancer and a deleterious or suspected deleterious germline BRCA mutation. The enrollee does not have a deleterious or suspected deleterious germline BRCA mutation.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.