Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mavyret, 100-40 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 Mavyret 100-40 mg.Mavyret 100-40 mg is requested to treat chronic hepatitis C genotype 1 in an enrollee status post liver transplant who is treatment experienced. The product label, available at drugs@fda, states: MAVYRET is a fixed-dose combination of glecaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg with chronic HCV genotype (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis. 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 does not satisfy the Plan's coverage criteria. The Plan requires: (The) patient is not receiving Mavyret in combination with another HCV direct acting antiviral agent. The prescriber stated that the enrollee has already had a 12 week course of Mavyret and that the plan is to treat with Mavyret in combination with Sovaldi and Ribavirin for an additional 24 weeks. Note that the product label, available at drugs@fda, addresses the treatment duration and states: Liver or Kidney Transplant Recipients: MAVYRET is recommended for 12 weeks in adult and pediatric patients 12 years and older or weighing at least 45 kg who are liver or kidney transplant recipients. A 16-week treatment duration is recommended in genotype 1-infected patients who are NS5A inhibitor-experienced without prior treatment with an NS3/4A PI or in genotype 3-infected patients who are PRS treatment-experienced.Also note that 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 none of the recommended treatment duration's for Patients Who Develop Recurrent HCV Infection Post Liver Transplantation is 24 weeks in duration. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or has not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Our Physician's opinion is that neither prior authorization nor prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is not required to cover Mavyret 100-40 mg tablet.