Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Harvoni. 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 Harvoni (Ledipasvir 90 mg-Sofosbuvir 400 mg). The drug is requested for a 24-week treatment for chronic hepatitis C virus (HCV), genotype 1a in a Ribaviran-eligible patient with decompensated cirrhosis, which is an off-label (non-FDA approved) use. DrugDex, a Medicare approved compendium, references the American Association for the Study of Liver Diseases (AASLD) guidelines for the treatment of Hepatitis C. Per the AASLD: Patients with decompensated cirrhosis who have genotype 1-6 and are Ribaviran eligible: Genotype 1, 4, 5, or 6 only: Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with low initial dose of ribavirin (600 mg, increase as tolerated to weight-based dose), Duration: 12 weeks.  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. 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 a treatment duration of 24-weeks.  Of note, the prescriber has indicated that the enrollee has a history of anemia due to esophageal variceal bleeding. The prescriber also indicated that the enrollee cannot tolerate Ribaviran due to history of anemia. However, per DrugDex (Under Medication Safety/Precautions section): Use (Ribaviran) oral tablets with caution in patients with baseline risk of severe anemia (e.g., spherocytosis, history of gastrointestinal bleeding); monitoring recommended. There is no documented Black Box warning for the use of Ribaviran with a patient history of anemia. 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 no citations in the Medicare approved compendia that support the use of Harvoni 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 Harvoni. 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.