Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Megestrol Acetate 40 mg tablet as prescribed. 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.Megestrol Acetate 40 mg is requested for treatment of marked weight loss, in this 76 year old enrollee with advanced metastatic renal/bladder cancer. The prescriber indicates that the enrollee has anorexia, cachexia, or nausea/vomiting. The prescriber further states that the enrollee's weight before developing metastatic disease was 225 pounds, and that the enrollee's current weight is 122 pounds (46% weight loss). 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.AHFS-DI (American Hospital Formulary Services Drug Information) states the following in the USES section for the requested drug, concerning the use of Megestrol Acetate for treatment of anorexia/weight loss/cachexia associated with advanced cancer:Megestrol acetate also has been used to stimulate appetite and promote weight gain in a limited number of patients with cachexia associated with neoplastic disease. In a large controlled study in patients with anorexia (i.e., an estimated daily caloric intake of less than 20 calories/kg) and/or cachexia (i.e., a weight loss of at least 2.3 kg in the period up to 2 months preceding the study) associated with advanced cancer (excluding endometrial carcinoma and breast cancer), therapy with megestrol acetate (800 mg daily) for a median time of 1.6 months resulted in a weight gain of at least 6.8 kg in 16% of patients compared with 2% of those receiving placebo; in megestrol-treated patients, this weight gain was 10% or more of baseline body weight. Patients receiving megestrol acetate reportedly had a higher incidence of improved appetite and food intake and a lower incidence of nausea and vomiting than those receiving placebo.Therefore, the requested drug is being prescribed for a medically accepted indication. The prescriber has indicated that the potential benefits of therapy with this high-risk drug outweigh the potential risks in this elderly enrollee, and that the enrollee will be regularly be monitored. The enrollee satisfies the Plan's coverage criteria.Our Physician Reviewer's opinion is that prior authorization 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 Megestrol Acetate for the diagnosed condition. As a result, Megestrol Acetate 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 Megestrol Acetate.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.