Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Mycophenolate Mofetil 500 mg. 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 Mycophenolate Mofetil 500 mg. Mycophenolate Mofetil 500 mg is requested for prevention of corneal rejection in a high-risk enrollee with Sjogren's Syndrome and keratoconjunctivitis sicca who is scheduled for a repeat corneal transplant. This diagnosis was clarified by you in the Reconsideration appeal.  The following citation in DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Mycophenolate Mofetil and cyclosporine were comparable for prevention of corneal rejection in high-risk patients. Patients scheduled for corneal transplant of mismatched MHC antigens were randomly assigned to receive mycophenolate mofetil 1 g twice daily (n=21) or cyclosporine (n=20) with dosage adjustment to achieve a target blood trough concentration between 120 and  150 nanograms/milliliter (ng/mL); patients also received systemic fluocortolone and topical prednisolone. Mycophenolate mofetil and cyclosporine were continued for 6 months. The overall rejection rate was 10% and 9.5% in the cyclosporine and mycophenolate mofetil groups, respectively. At 1 year of follow-up, all corneal grafts remained clear. One cyclosporine-treated patient discontinued therapy due to hepatotoxicity, while 2 patients stopped mycophenolate mofetil of whom 1 developed Hodgkin's lymphoma at 1 month (probably unrelated to mycophenolate mofetil) and required better immunosuppression for a dermatologic condition. Mycophenolate mofetil was effective and tolerated well without incurring the additional costs of frequent monitoring required by cyclosporine.  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. You have indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that 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 met. Therefore, our decision is the Plan is required to cover Mycophenolate Mofetil 500 mg.