Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Stromectol and Levalbuterol. The Plan did not grant this request. We receivedthis case to conduct an independent review.Stromectol:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Stromectol 3 mg. Stromectol 3 mg is requested for treatment of the enrollee's condition. GenericIvermectin is on the Plan's formulary. You stated that brand name was all the pharmacy had becausegeneric was unavailable from the wholesaler. You have not provided sufficient documentation that allalternatives required by the Plan would likely not be as effective for the enrollee as the requested drug;and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to thePlan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exceptioncriteria are not met. Of note, Ivermectin is not listed on the FDA shortages list.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 not met.Therefore, the Plan is not required to cover Stromectol.Levalbuterol:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Levalbuterol nebulizer solution. Levalbuterol nebulizer solution is requested for treatment of Covid 19related symptoms including shortness of breath and wheezing, which is an off-label (non-FDA approved)use. The Medicare-approved compendia do not contain any citations to support the use of the requesteddrug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not beingprescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions requestbased on medical necessity cannot be considered because the requested drug, as prescribed, does not meetthe definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Levalbuterol for the diagnosed condition. As a result, the drugis not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannotbe covered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Levalbuterol.This decision does not concern the medical necessity of the requested drugs. It only establishes if paymentcan be made under the Medicare Part D benefit.