Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover AmBisome 50 mg. 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 AmBisome 50 mg lyophilized product for IV infusion; 25 mg (6 mL) suspension dose to be administered via nebulization once per week, for 90 days.The drug is requested for fungal infection prophylaxis, primarily the anastomotic site, in this 73 year old patient status post lung transplant. 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 following citation in AHFS-DI, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Conventional amphotericin B,Ref amphotericin B lipid complex, and amphotericin B liposomal have been administered by nasal instillation or nebulization in an attempt to prevent aspergillosis in immunocompromised patients, including solid organ transplant recipients (e.g., lung transplant recipients) and neutropenic chemotherapy patients. Therefore, the requested drug is being prescribed for a medically accepted indication. The prescriber has documented fungal prophylaxis with an echinocandin (Micafungin 100 mg IV every 24 hours), a systemic medication along with nebulized Amphotericin B. The prescriber stated that the requested medication is prescribed to prevent fungal infection in the newly transplanted lung, particularly at the anastomotic site. 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 formulary exception criteria are met.Medicare law specifically excludes coverage for any drug for which payment would be available under Part A or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. AmBisome is not a drug that is covered in the Medicare Part B nebulizer durable medical equipment rules. Therefore, it is not eligible for coverage under Medicare Part B and we sent the request to our physician reviewer to review for coverage under Medicare Part D.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 AmBisome.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.