Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Megestrol Acetate 40 mg/ml suspension. 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 Megestrol Acetate 40 mg/ml suspension. Megestrol Acetate 40 mg/ml suspension is requested for ongoing use for treatment of cachexia and weight loss in this 87-year-old enrollee which the prescriber has indicated is related to complex medical conditions which include, but are not limited to COPD (chronic obstructive pulmonary disease). The conditions are specifically noted on the initial coverage request form dated 1/9/20 and acknowledged in the Plan's notes. 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 diagnosis of COPD is noted in the Non-FDA uses section of DRUGDEX for the requested drug supported by the following citation: Megestrol acetate (MA) effectively increased appetite and body weight, stimulated ventilation, and improved body image in underweight (less than 95% ideal body weight) patients with chronic obstructive pulmonary disease (COPD), but did not improve respiratory muscle function or exercise tolerance. Weisberg J, Wanger J, Olson J, et al: Megestrol acetate stimulates weight gain and ventilation in underweight COPD patients. Chest 2002; 121:1070-1078. Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee does not satisfy the Plan's coverage criteria. However, the prescriber has indicated that the enrollee has been stable on this drug for years, and that there is a high risk for significant adverse clinical outcome with a change in treatment. 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.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 Megestrol Acetate 40 mg/ml suspension.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.