Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Modafinil. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Modafinil 100 mg. Modafinil 100 mg is requested for ongoing treatment of fatigue, mood swings, andproblems with focus/attention related to several diagnoses including fibromyalgia, ADHD (attention deficitdisorder), and bipolar disorder with depression. You submitted medical records documenting the conditionsbeing treated. You stated that the enrollee has trialed multiple medications in the past including AdderallAtomoxetine, several SSRI's, and mood stabilizers which were ineffective or resulted in adverse effects.Since recently starting samples of Modafinil, the records indicate that the enrollee reports improvement inenergy, concentration, focus and mood springs; you also stated that prior to Modafinil, the enrollee'sdepressed mood has not been controlled. You added that in addition to Modafinil, the enrollee is beingtreated with Bupropion and Prazocin.For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for amedically accepted indication. Our Physician Reviewer found that the Medicare-approved resources docontain citations to support the use of the requested drug for treatment of the noted condition. Drugdex hasmultiple citations in their non-FDA uses section for Modafinil that support the use of Modafinil in thispatient including the following: Adjunctive Modafinil increased remission rate and had a significant effecton mood scores in a meta-analysis of patients with depressive episodes secondary to major depressivedisorder or bipolar disorder [6]. In a separate meta-analysis, dopaminergic agents, including Modafinil,significantly improved clinical response and remission compared with alternative active treatment orplacebo in patients with bipolar disorder [A systematic review identified 6 randomized, placebo-controlled,6- or 8-week studies of adjunctive treatment with modafinil or armodafinil for depressive episodes of majordepressive disorder (4 studies in 568 subjects) and bipolar depression (2 studies in 342 subjects). The metaanalysisof 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 DepressiveSymptomatology (point estimate, -0.23), but had no effect on sleepiness. Therefore, the requested drug isbeing prescribed for a medically accepted indication. The prescriber has indicated why all alternativesrequired by the Plan would likely not be as effective as the requested drug for the enrollee, and/or wouldlikely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan'scoverage criteria is medically necessary. Our Physician Reviewer's opinion is that formulary exceptioncriteria are met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are met. Therefore,the Plan is required to cover Modafinil.