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 metastatic cancer non-small cell lung cancer (NSCLC), which is an off-label (non-FDA approved) use. The enrollee is a 75-year-old man with multiple comorbidities. He presented with pleural effusion that yielded malignant cells with a differential of pancreatic, bladder or lung origin per the pathology report. PET imaging showed:1. Large right pleural effusion. Significant right basilar partial consolidation. Within the consolidated right lower lobe there is a foal area of increased metabolism somewhat mass-like suspicious for malignancy. 2. There are small areas of increased metabolism adjacent to the glenohumeral joints probably related to degenerative and/or inflammatory change. Moe focal small subcentimeter foci right axilla are hypermetabolic and may be secondary to adenopathy. Enlarged lymph nodes are not appreciated. 3. Small portacaval lymph node is mildly hypermetabolic and may be metastatic. 4. Findings suspicious for malignancy in the abdomen or pelvis are otherwise not identified. Guardant 360 testing identified ATM mutations suggesting possible response to Ibrance (Palbociclib). None of the guideline recommended molecular markers were positive. The prescriber requests Ibrance to treat him.  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. 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. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that 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.