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 non-small cell lung cancer (NSCLC) without EGFR exon 19 deletion, exon 21 L858R mutation, or EGFR T790M mutation, which is an off-label (non-FDA approved) use.The enrollee is a 69-year-old woman with metastatic NSCLC involving brain, lung, nodes, pleural and possibly pericardium. She has been treated with radiation, Carboplatin, Taxol, Gemzar, Cyramza, Taxotere, Yervoy, and Opdivo. Her most recent CT on 4/24/20 shows: 1. A large right sided pleural effusion, with complete compressive atelectasis of the right lung. 2. Mild parenchymal heterogeneity of the atelectatic right middle and right lower lobes, which may represent some element of superimposed airspace disease. 3. Opacified right mainstem bronchus, which may be due to mucoid impaction. 4. Small to moderate pericardial effusion. 5. Moderate centrilobular emphysema. 6. Incidental punctuate 0.6 cm irregular non calcified pulmonary nodule within the left lower lobe. Guarant360 testing identified an EGFR R108K mutation suggesting possible response to Osimertinib (Tagrisso).The prescriber requests Tagrisso to treat her. A study abstract and an article from the Journal of Clinical Oncology (JCO) were submitted for review. Per Medicare rules, abstracts cannot be used to determine medically accepted use. The article from JCO relates to treatment naive patients and none of the patients had the specific EGFR mutation of the enrollee. The enrollee has had multiple treatment regimens. Therefore, the article does not reflect her clinical situation.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.