Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Alunbrig, 90 mg tablet. 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 Alunbrig 90 mg; 60/30.The drug is requested to treat ALK mutated metastatic lung cancer without prior therapy with Crizotinib, which is an off-label (non-FDA approved) use. The enrollee is a 77 year old man with adenocarcinoma of lung, a type of non-small cell lung cancer, involving bones, liver and adrenals. The tumor has an EMLA-ALK fusion mutation. He was treated with Gemcitabine/Cisplatin and did not tolerate it well. He has since had Alcetinib and Lorlatinib. He has progression of the cancer in December 2019. Options included a clinical trial and chemotherapy with Carboplatin/Pemetrexed. The prescriber requests Alunbrig to treat him.A meeting abstract and two journal articles were submitted in support of the request. The abstract was not legible in the files submitted and was found by this reviewer on line (DOI: 10.1200/JCO.2019.37.15_suppl.9027 Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019) 9027-9027) and reviewed. It reports early findings in an ongoing clinical trial. In addition, the abstract does not give sufficient information to know whether patients in the trial reflect the enrollee's clinical situation. The articles were reviewed and do not reflect the enrollee's clinical situation. The NCCN guidelines were also reviewed as the prescriber cited them in support of the request. The guidelines reflect the NCCN compendium recommendation to use the drug after failure of or intolerance to Crizotinib. The enrollee has not been treated with Crizotinib.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 Alunbrig, 90 mg tablet 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 Alunbrig, 90 mg tablet. 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.