Appeal type: Prescription Drug
Decision: Favorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Stivarga 40 mg. 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 Stivarga 40 mg. The drug is requested to treat metastatic colorectal cancer.The enrollee is a 74-year-old man with multiple comorbidities metastatic rectal cancer involving lung and pleura. He has been treated with surgery and radiation, 5FU, Keytruda, Oxaliplatin, Irinotecan and Bevacizumab (an anti-VEGF treatment). His tumor is KRAS mutated. He had 5FU with radiation and became severely ill due to the 5FU and was diagnosed with DPD deficiency. The prescriber states he cannot have 5FU. He had progressive cancer on Keytruda. He did not tolerate Irinotecan, Oxaliplatin and Bevacizumab due to life threatening swings of his INR and severe volume depletion due to diarrhea. This led to hospitalization. The prescriber requests Stivarga to treat him.Per the FDA website, Stivarga is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with Fluoropyrimidine, Oxaliplatin and Irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wildtype, an anti-EGFR therapy. The enrollee meets these criteria. He meets the Plan's prior authorization criteria for prior treatment with intolerance to 5FU, Oxaliplatin, Irinotecan, and Bevacizumab.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 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 Stivarga 40 mg for the diagnosed condition. As a result, Stivarga 40 mg 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 Stivarga 40 mg.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.