Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tagrisso . 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 Tagrisso 80 mg. The drug is requested to treat previously treated metastatic lung cancer, which is an off-label (non-FDA approved) use. The enrollee is a 69 year old man with metastatic non-small cell lung cancer (NSCLC) involving brain and bone. His tumor has an EGFR exon 21 L858R mutation detected by NeoGenomics. The enrollee has been treated with brain radiation, Carboplatin, Pemetrexed and Keytruda. Cycle one of chemotherapy was given. The prescriber requests Tagrisso to treat him. The prescriber states he was initially treated with chemotherapy before the EGFR testing was completed and he has been in remission on maintenance Keytruda. The office note states he had a new left cerebellar metastasis treated with stereotactic radiation. The prescriber states that the request is for first line treatment of the new progression. This reviewer notes that the EGFR report was dated prior to beginning chemotherapy for metastatic NSCLC cancer. And the current treatment is second line treatment for metastatic NSCLC. Therefore the requested use does not meet a medically accepted use which is for first line treatment in patients with appropriate EGFR mutations.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 Tagrisso 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 Tagrisso. 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.