Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Modafinil 100 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 Modafinil 100 mg. Modafinil 100 mg is requested for treatment of excessive daytime sleepiness and chronic depression following a stroke. You have indicated that other treatment including antidepressants have not been effective. The medical record indicates that anti-depressants have been discontinued without worsening of mood; however excessive daytime drowsiness persists. The Plan concluded that the noted indication is not a medically accepted indication for the use of Modafinil.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 has a link from their monograph on the requested drug under the heading of Narcolepsy in the Adult Dosing and Non-FDA uses section to their DRUG CONSULTS monograph titled Narcolepsy and Cataplexy - Drug Therapy; which cites the American Academy of Sleep Medicine Consensus Practice Parameters for the Treatment of Narcolepsy and other Hypersomnias of Central Origin (Sleep. 2007 Dec 1; 30(12): 1705-1711.) which state, Based on evidence and/or long history of use in the therapy of narcolepsy, committee consensus was that modafinil, amphetamine, methamphetamine, dextroamphetamine, and methylphenidate are reasonable options for the therapy of hypersomnia of central origin. Hypersomnia of central origin includes hypersomnia due to a medical condition. As noted, the enrollee as has had excessive daytime sleepiness following a stroke. 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 Modafinil 100 mg.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.