Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sutent and Lenvima. 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 Lenvima 14 mg; cap therapeutic pack 10mg + 4mg 420/30 and Sutent 37.5 mg; 30/30. The drugs are requested to treat the hepatocellular carcinoma (HCC) which is an off-label (non-FDA approved) use. The enrollee is a 64 year old with abnormal alpha fetoprotein (AFP) and abnormal liver on imaging.No biopsy has been performed. He has a history of hepatitis C supposedly in remission. His liver enzymes were normal with mild elevation of bilirubin to 1.4 and total protein of 7.3. His AFP was 15,812.6. MRI imaging showed: cirrhotic appearing liver with portal hypertension including splenomegaly. Large varices appear to penetrate the posterior wall of the gastric fundus, multiple hepatic lesions throughout the right lobe of the liver consistent with hepatocellular carcinoma. The largest lesion measures up to 85 cm x 9.7 cm. In the left lobe of the liver segment IV is a 7 mm focus of diffusion restriction which probably also represent hepatocellular carcinoma however a corresponding enhancing lesion is not seen. Lymphadenopathy posterior the pancreatic head/body and periaortic lymphadenopathy consistent with metastatic disease. Small amount of ascites. He has not had treatment. The prescriber requests Sutent to be given with Lenvima to treat him. He is also being referred to radiology for nuclear seed implants.In response to inquiry, the prescriber states that no biopsy was done. He is not a surgical candidate.The prescriber states he does not want to use Sutent but wants to use Sorafenib.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 Sutent and Lenvima 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 Sutent and Lenvima. 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.