Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Octagam. 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 Octagam 10% solution. Octagam 10% solution (intravenous immune globulin -IVIG) is requested for treatment of severe refractory disfiguring discoid lupus erythematosus and pemphigus erythematosus, a variant of pemphigus foliaceous, in this enrollee with systemic lupus erythematosus. The prescriber has provided detailed medical records which document the presence of both dermatologic conditions on biopsy. The prescriber has documented the refractory course of the enrollee's disease requiring multiple hospitalizations. There has been failure of multiple immunosuppressive agents and response to IVIG in the past. The prescriber has provided medical literature to support the use of IVIG for treatment of both of the noted dermatologic conditions. 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. The following citation is noted in the discussion on pemphigus vulgaris in the FDA uses section of DRUGDEX: A single cycle of high-dose IV immune globulin in patients with pemphigus resistant to systemic steroids resulted in significantly prolonged time on protocol without need additional treatment compared with placebo in a multicenter, randomized, placebo-controlled, double-blind study (n=61). The study included patients with multiple types of pemphigus. Amagai M, Ikeda S, Shimizu H, et al: A randomized double-blind trial of intravenous immunoglobulin for pemphigus. J Am Acad Dermatol 2009; 60(4):595-603. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has 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. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Octagam.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.