Appeal type: Prescription Drug
Decision: Favorable

At issue is a request for coverage of Mavyret (Glecaprevir 100 milligrams/ Pibrentasvir 40 milligrams) tablets, 3 tablets once daily for eight weeks. The Part D plan denied the request because the drug was not included on the plans formulary and the documentation did not support a formulary exception.  We received the case to perform an independent and de novo review. To make our decision, we read the case file carefully. We reviewed all documentation submitted. This includes the case file from the plan and any information submitted at the reconsideration level.The submitted medical records indicate that Mavyret has been prescribed for treatment-naive genotype 2a chronic hepatitis C without cirrhosis, which is a medically accepted indication outlined in the Medicare approved compendia. As outlined in the American Association for the Study of Liver Diseases, the recommended regimen for treatment-naive genotype 2a chronic hepatitis C without cirrhosis is a daily fixed-dose combination of Glecaprevir (300 milligrams)/Pibrentasvir (120 milligrams) for a course of eight weeks, which is what has been ordered by the prescriber. Therefore, the submitted medical records support that the Mavyret is being prescribed for a medically accepted indication as outlined in the Medicare approved compendia and that the requirements outlined in the American Association for the Study of Liver Diseases have been met. Mavyret is not included on the plans formulary. The plan has noted in their denial that the prescriber has not given specific medical reasons why the enrollee cannot use the preferred formulary drug, Epclusa tablet. However, as noted by the prescriber at reconsideration the enrollee is taking oxcarbazepine for bipolar disorder and pantoprazole for gastroesophageal reflux disease, and that there can be serious drug-to-drug interactions with Epclusa and these two drugs. The submitted medical records do validate that the enrollee is taking pantoprazole for gastroesophageal reflux disease and taking oxcarbazepine for bipolar disorder. As outlined in the Medicare approved compendium, DrugDex, there is a possible major interaction noted between Epclusa and proton pump inhibitors, such as pantoprazole. Additionally, there is a possible major interaction noted between Epclusa and strong or moderate CYP3A4 inducers, such as oxcarbazepine. The prescriber has noted that the enrollees Lipitor/atorvastatin will be discontinued during the 8-week treatment with Mavyret since this would be a contraindication to Mavyret. However, the pantoprazole and oxcarbazepine cannot be discontinued for any length of time to try Epclusa, as it is medically necessary for the enrollee to continue treatments with those medications. Therefore, the documentation does support that the administration of Epclusa is contraindicated in this case due to the possible serious drug-to-drug interactions between Epclusa and pantoprazole, and between Epclusa and oxcarbazepine. As noted by the American Association for the Study of Liver Diseases, Epclusa and Mavyret are the only treatment options listed for the enrollee's condition. Therefore, the submitted documentation supports a formulary exception in this case. A physician reviewed the appeal and determined that the plan is required to cover the Mavyret under a formulary exception.