Appeal type: Prescription Drug
Decision: Partially 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 and provide a tiering exception for 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 65 year old man with rectal cancer diagnosed in 2005. He now has recurrent, metastatic colorectal cancer involving lungs and pelvis. His tumor is KRAS wild type. He has been treated with radiation, 5FU, Leucovorin, Oxaliplatin, Xeloda, Irinotecan, Avastin and Cetuximab. He has slight progression of the lung lesions on CT scan of 12/11/19. The prescriber requests Stivarga to treat him. Per Clinical Pharmacology, Stivarga is indicated for the treatment of metastatic colorectal cancer in patients who have previously received fluoropyrimidine-, Oxaliplatin-, and Irinotecan-based chemotherapy; an anti-VEGF therapy; and an anti-EGFR therapy if RAS wild type. 5FU and Xeloda are fluoropyrimidines, Avastin is an anti-VEGFtreatment and Cetuximab is anti-EGFR. Therefore the enrollee has been previously treated with all of the required drugs.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 for the diagnosed condition. As a result, Stivarga 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.If a Plan maintains a specialty tier, the Plan may design its exception process so that drugs placed in the specialty tier are not eligible for a tiering exception. Stivarga is in the specialty tier. The record indicates the Plan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is not required to provide a tiering exception for Stivarga.