Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Lonsurf, 45 mg as prescribed. 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 Lonsurf, 45 mg.The drug is requested to treat metastatic adenocarcinoma of the rectum. The enrollee has a diagnosis of stage IV adenocarcinoma of the rectum, with liver metastases, with KRAS mutation, BRAF wild type. Upon reconsideration, the prescribing physician has submitted additional documentation including statement, chart notes and chemotherapy records. The enrollee was treated with chemotherapy including FOLFIRI, Capecitabine, FOLFOX, Avastin, Camptosar, and Folfox, as well as radiation therapy. The documentation submitted supports that the enrollee received treatment with Avastin (Bevacizumab), an anti-VEGF therapy. 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. The following citation in DrugDex, a Medicare-approved compendium, supports the use of the requested drug for the enrollee's condition:Trifluridine/tipiracil is indicated for the treatment of adults with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization 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 Lonsurf, 45 mg as prescribed for the diagnosed condition. As a result, Lonsurf, 45 mg as prescribed 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 Lonsurf, 45 mg as prescribed.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.