Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Imatinib Mesylate 100 mg tablet, 90 tablets per 30 days. 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 Imatinib Mesylate 100 mg, 90 tablets per 30 days. Imatinib Mesylate is requested to treat recurrent, metastatic gastrointestinal stromal tumor (GIST). The enrollee is a 79 year old man with GIST. He was first diagnosed in 2017 and treated with Gleevec (Imatinib mesylate). The drug was stopped due to watery bowels, leg cramps and weakness. He then had surgery with removal from the stomach and tumor was found in the omentum. He did not receive post-operative, adjuvant Gleevec. In December of 2019 he had repeat surgery for GIST involving stomach, liver capsule and omentum. The proximal margin of the stomach was involved with tumor. You note he is at high risk for recurrence. His tumor has PDGFR1 mutation. The documentation does not indicate there is a c-Kit mutation. You request Imatinib Mesylate to treat him as adjuvant therapy. In response to inquiry you state there are no other treatment options. The enrollee has recurrent and metastatic GIST. There is residual tumor at the most recent surgical margin. Therefore the use is for treatment of recurrent/metastatic cancer. The NCCN compendium states the drug is indicated for Primary treatment for patients with documented GIST that is resectable with negative margins but with risk of significant morbidity, unresectable, recurrent, metastatic. In the opinion of this reviewer, the requested treatment is primary therapy for recurrent and metastatic GIST. This NCCN compendium listing does not indicate the tumor must be c-Kit mutated. Therefore the requested use is a medically accepted use.For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee does not satisfy the Plan's coverage criteria. You have indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that prior authorization exception criteria are met.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. 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. Our Physician Reviewer reviewed this file and determined that there are citations in the Medicare approved compendia that support the use of Imatinib Mesylate for the diagnosed condition. As a result, Imatinib Mesylate is being prescribed for a medically accepted indication as defined by Medicare law. Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Imatinib Mesylate 100 mg tablet, 90 tablets per 30 days.