Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Onfi 10 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 Onfi 10 mg tablet. Brand Onfi 10 mg tablet is requested for ongoing treatment of medically refractory focal seizures which have improved with the addition of the requested drug. Detailed medical records and supportive medical literature have been provided. It is well documented that the enrollee has failed multiple drug trials alone and in combination, she has had an adverse reaction to generic equivalent of Onfi, and that her seizures have been well controlled on a multi-drug regimen that includes brand Onfi. 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. Drugdex states the following in the non-FDA uses section in its discussion of EPILEPSY: Adjunctive therapy with clobazam has been effective in the treatment of uncontrolled or refractory epilepsy in adults and children (Robertson, 1986; Scott & Moffett, 1986; Tinuper et al, 1986; Aucamp, 1985; Allen et al, 1983; Franceschi et al, 1983; Shimizu et al, 1982). Effective doses have been 20 to 30 mg/day (Aucamp, 1985). Unfortunately, tolerance to the drug has been reported (Schmidt et al, 1986). A comprehensive review of the open and controlled studies of clobazam in the treatment of epilepsy is available (Robertson, 1986). The following guideline is then stated: Clobazam is adjunctive treatment of refractory focal seizures (partial seizure and localization-related seizure) in children, young adults, and adults if first-line treatment is ineffective or not tolerated.Therefore, the requested drug is being prescribed for a medically accepted indication. OF NOTE - the Plan states in its internal notes that Onfi is listed as a Class III evidence level for epilepsy, which does not meet the definition of a medically accepted indication for a Part D drug. However, the Medicare Part D regulations only require a single favorable citation in the Medicare approved compendia that supports theuse of the requested drug for treatment of the enrollee's condition to meet medically accepted indication 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 formulary exception criteria are met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are met. Therefore, the Plan is required to cover Onfi 10 mg tablet.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.