Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Stivarga, 40 mg tablet. 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 tablet.   The drug is requested to treat the enrollee's condition which is an off-label (non-FDA approved) use. The enrollee is a 73 year old woman with metastatic colon cancer involving adrenals, nodes, peritoneum, liver, pleural effusion and pelvis. She has been treated with Xeloda (a Fluoropyrimidine), Lonsurf and Lynparza. Her tumor is wild-type KRAS. CT scans on October 5, 2020 showed progression of the cancer. The prescriber requests Stivarga to treat her. The prescriber states she is extremely sensitive to several medications including anesthesia and she has declined all IV chemotherapy. The enrollee states she cannot tolerate what is in liquid chemotherapy and that Stivarga has promise of extending her life and liquid chemotherapy does not. The enrollee has not been treated with Oxaliplatin, Irinotecan, a VEGF inhibitor, or as her tumor is KRAS wild type, anti-EGFR therapy.   The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.  For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. For Part D drugs used in an anticancer chemotherapeutic regimen, 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 or peer-reviewed medical literature in CMS-approved journals or publications.  Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Stivarga, 40 mg tablet for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Stivarga, 40 mg tablet.  This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.