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. The drug is requested to treat lung cancer without a sensitizing EGFR mutation, which is an off-label (non-FDA approved) use.The enrollee is a 75-year-old woman with metastatic non-small cell lung cancer (NSCLC) involving lungs and brain. She has been treated by surgery, Carboplatin, Pemetrexed, Pembrolizumab, Avastin and radiation. Her tumor has polysomy of ALK and an EGFR 20 insertion. It does not have a sensitizing EGFR mutation. The prescriber requests Tagrisso to treat her. The prescriber cites a non-CMS approved journal and a citation from the J of Clinical Oncology by Rless as well as the BLOOM trial.The BLOOM trial required a sensitizing EGFR mutation so does not reflect the enrollee's clinical situation. (NCT03497767 on Clinicaltrials.gov). This reviewer searched PubMed and the J of Clinical Oncology website for the article by Rless and found no citations by that author and none relating to the requested use of Osimertinib without a sensitizing EGFR mutation. Page MS-14 of the NCCN Guidelines Version 3.2020 Non-small Cell Lung Cancer states Data suggest that patients harboring tumors without sensitizing EGFR mutations should not be treated with EGFR TKIs in any line of therapy. Osimertinib is an EGFR TKI.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.