Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Risperdal. 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 Risperdal 2 mg tablet. Risperdal 2 mg tablet, 1.5 tablets at 7 am and 1 pm, then 1 tablet each night, 4 daily, 120 per 30 days, is requested for ongoing treatment of F06.34 - mood disorder due to known physiological condition with mixed features, associated with behavioral issues including outbursts with aggression, in this enrollee with generalized anxiety disorder, chronic post-traumatic stress disorder, epilepsy, severe intellectual disability, spastic diplegic cerebral palsy, and hypoplasia of the cerebellar hemispheres as well as the pons. 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 the following statement in the non-FDA uses section of the requested drug under the discussion of Behavioral syndrome-intellectual disability: RisperiDONE moderately improved aberrant behavior in adults with mental retardation compared with placebo in a 4-week, randomized, double-blind, placebo-controlled study (n=77) with continued improvement over 48 weeks in an open-label, extension study. Therefore, the requested drug is being prescribed for a medically accepted indication. However, the Plan's denial letter states that there is no citation to support the use of Risperdal tablets, with dosing that exceeds 4 mg per day, for the treatment of aberrant behavior in adults with mental retardation. Of note, Medicare Part D regulations state that medically accepted indication refers to the diagnosis being treated, not the dose of drug being used to treat the indication. As discussed, there is a citation that supports the use of the requested drug for treatment of the enrollee's condition; therefore Risperdal is being prescribed for treatment of a medically accepted indication. You have provided a sufficiently strong statement supported by submitted medical records as to why ongoing treatment with the requested medication at the requested dose is the best, and most appropriate, option for this enrollee. The enrollee is currently taking over 15 medications, including 9 which are psychoactive and being prescribed to treat the enrollee's seizure disorder, mental health, and behavioral issues. You have indicated that theenrollee is stable on the current medication regimen, the enrollee has failed the generic equivalent, the enrollee is medically and mentally complex and fragile, and that any changes in the enrollee's medication regimen could interfere with the enrollee's well-being. You also indicated that 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. Of note, the Plan also brought up the issue of quantity/dose being prescribed. The request is for an off formulary drug; therefore quantity limit cannot be applied. With regards to safety, the enrollee has been stabilized on the requested dose/quantity of the requested drug in combination with multiple other drugs; the current medication regimen has been effective and well tolerated.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 Risperdal.