Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tagrisso and Xalkori. 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, 30 per 30 days and Xalkori 200 mg, 60 per 30 days. The drugs are requested to treat non-small cell lung cancer (NSCLC) in combination, which is an off-label (non-FDA approved) use. The enrollee is a 66 year old woman with metastatic NSCLC involving liver, bones, nodes and soft tissue. Her tumor was positive for an EGFR mutation. She has been treated with surgery, radiation, Carboplatin/Taxol, Tagrisso which was stopped due to progressive cancer. She was switched to Carboplatin/Alimta/Avastin. On progression she was switched to Docetaxel/Ramucirumab, then Tecentriq/Paclitaxel, then on further progression to Gemcitabine and then Vinorelbine. Foundation One CDx testing identified an EGFR exon 19 deletion and MET amplification. The level of the MET amplification is not stated. FISH MET testing has been ordered. Her performance status is ECOG 2 and she has pain due to cancer. Her CEA has been trending up. A lung specialist recommended the combination. You are requesting Tagrisso and Xalkori to treat her.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 and Xalkori 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 and Xalkori.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.