Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Abelcet. The Plan did not grant this request. We received this case to conduct an independent review.We sent the case file to a Physician Reviewer. We asked this doctor to determine whether the Plan was correct in denying the request for Abelcet.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Abelcet 100 mg/20 m vial. Abelcet 50 mg, inhaled via nebulizer is requested for the treatment and prophylaxis of aspergillus in an immunocompromised enrollee with a history of cystic fibrosis, status post lung transplant. You sent a letter dated 1/21/2020 clarifying the medical history. 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, amphotericin B lipid complex,[Ref] 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. Ref: Marino E, Gallagher JC. Prophylactic antifungal agents used after lung transplantation. Ann Pharmacother. 2010; 44:546-56. Ref: Borro JM, Sol? A, de la Torre M et al. Efficiency and safety of inhaled amphotericin B lipid complex (Abelcet) in the prophylaxis of invasive fungal infections following lung transplantation. Transplant Proc. 2008; 40:3090-3. Conclusions: Nebulized amphotericin B lipid complex (ABLC) was effective, safe, and well tolerated for the prophylaxis of aspergillosis in lung transplant patients during the early posttransplant period. Therefore, the requested drug is being prescribed for a medically accepted indication. Abelcet is not on the Plan's formulary. Generic amphotericin B and Ambisome are on the Plan's formulary. You have not indicated why all alternatives 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 the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria are not metMedicare 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. Medicare Part B local policy states that a small volume nebulizer and related compressor are covered when medically necessary to administer Abelcet for the management of obstructive pulmonary disease. In this case, the record shows that Abelcet is administered for a diagnosis of treatment and prophylaxis of aspergillus. Medicare Part B does not provide coverage for Abelcet for this diagnosis. Thus, Abelcet would not be eligible for Part B coverage in this case. We therefore asked our Physician Reviewer to determine if Part D coverage criteria have been met.