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 colon cancer.The enrollee is a 75-year-old man with chronic lung disease and history of blood clots and pulmonary emboli and gastrointestinal bleeding. He has metastatic colon cancer involving liver, and soft tissue in the abdomen. He has been treated with 5FU, Leucovorin, Oxaliplatin, Irinotecan, and Avastin. His tumor is KRAS mutated. CAT scans on 12/4/19 showed increased size of the right upper quadrant masses. The prescriber requests Stivarga to treat him. The office records submitted do not include an ECOG performance status. The prior authorization form of 12/24/19 notes the ECOG to be 2. In response to inquiry, the prescriber states that the enrollee's ECOG status is 1 and that he has multiple co morbid conditions which impact his performance status. From his cancer perspective his ECOG score is 1.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 wild type, an anti-EGFR therapy. The enrollee's tumor is not RAS wild type. Therefore, he meets the FDA indication as he has been previously treated with the other drugs. The prescriber has explained the ECOG score is 1 which meets the prior authorization criteria.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.