Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Gilotrif. 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 Gilotrif 40 mg, 30 per 30 days. 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 man with lung cancer involving both lungs. The office notes of February 5, 2020 indicate it is adenocarcinoma. You stated the diagnosis is squamous cell carcinoma in a letter dated March 30, 2020. He has been treated with Carboplatin, Alimta, and Keytruda. Imaging on March 24, 2020 showed mixed results with increased tumor in the right adrenal gland and lung. The tumor is EGFR negative. You request Gilotrif to treat him. You state that an alternative would be Taxotere and Cyramza but the enrollee is currently not able to receive that due to performance status. Both squamous and adenocarcinoma are types of non-small cell lung cancer (NSCLC). The use of the drug is FDA approved for use in squamous cell lung cancer after progressing on Platinum based chemotherapy. It is approved for first line use in NSCLC that has a non-resistant EGFR mutation. The requested use is second line treatment in EGFR negative NSCLC. A request for information was sent to clarify the conflicting information. You did not submit the requested information. Therefore this reviewer cannot determine that the requested use is a medically accepted 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 Gilotrif 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 Gilotrif. 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.