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 the enrollee's condition, which is an off-label (non-FDA approved) use.The enrollee is a 71-year-old woman with ovarian cancer. She is in complete or partial response to first-line Platinum based chemotherapy. The plan is to initiate the drug no later than 8 weeks after chemotherapy.Limited clinical information was submitted with the appeal. The prescriber requests Lynparza to treat her as monotherapy. In response to a request for information, the prescriber indicated she has been treated with 1 cycle of Carboplatin/Taxol and 8 cycles of Carboplatin/Doxil. She had a complete response. Medical records were not submitted as requested in the inquiry. There is no indication the enrollee has a BRCA mutation or HRD (homologous recombination deficiency). The prescriber states an alternative option would be Niraparib however she has had thrombocytopenia in the past, which is a more pronounced toxicity with Niraparib. The prescriber's preference is Lynparza.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.