Appeal type: Prescription Drug
Decision: Favorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Modafinil. 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 to treat daytime fatigue associated with depression and cerebral infarction. 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 citations in DrugDex, a Medicare approved compendium, support the use of the requested drug for the enrollee's condition: A systematic review identified 6 randomized, placebo-controlled, 6- or 8-week studies of adjunctive treatment with modafinil or armodafinil for depressive episodes of major depressive disorder (4 studies in 568 subjects) and bipolar depression (2 studies in 342 subjects). The meta-analysis of 5 studies showed that adjunctive modafinil significantly improved fatigue (point estimate, -0.15) and mood scores, measured by Hamilton Depression Rating Scale or Inventory of Depressive Symptomatology (point estimate, -0.23), but had no effect on sleepiness [6] [6]. Goss AJ, Kaser M, Costafreda SG, et al: Modafinil augmentation therapy in unipolar and bipolar depression: a systematic review and meta-analysis of randomized controlled trials. J Clin Psychiatry 2013; 74(11):1101-1107.DrugDex has a link from their monograph on the requested drug 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.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.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are citations in the Medicare approved compendia that support the use of Modafinil for the diagnosed condition. As a result, Modafinil is being prescribed for a medically accepted indication as defined by Medicare law. 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 Modafinil.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.