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 previously treated lung cancer, which is an off-label (non-FDA approved) use. The enrollee is an 83 year old woman with stage IV non-small cell lung cancer (NSCLC.) The prescriber states her tumor has EGFR T790M mutation. In response to inquiry, the prescriber states the tumor has an EGFR exon 19 deletion. She has been previously treated with concurrent Carboplatin, Pemetrexed and radiation. She started Tagrisso (Osimertinib) in 8/2019. The prescriber states other treatments have failed and there are other treatment options. The other options would have worse clinical outcome. No other medical records were submitted for review despite a request for them. The prescriber cited the NCCN Guidelines Version 7.2019 which lists the use of Osimertinib as first line therapy. The returned information indicates this is not first line therapy.Medical records were not submitted as requested. The submitted information has conflicting statements. The FDA indication is: first-line treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. And the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy. 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.