Arikayce (amikacin liposome inhalation suspension) — Blue Cross Blue Shield of Alabama

Initial criteria

• - Diagnosis of MAC lung disease confirmed by BOTH: • At least ONE clinical finding: - Pulmonary or systemic symptoms; OR - Nodular or cavitary opacities on chest radiograph; OR - High-resolution computed tomography scan showing multifocal bronchiectasis with multiple small nodules AND • At least ONE microbiological finding: - Positive culture results from at least two separate expectorated sputum samples; OR - Positive culture result from at least one bronchial wash or lavage; OR - Transbronchial or other lung biopsy with mycobacterial histopathologic features (granulomatous inflammation or acid-fast bacilli [AFB]) AND positive culture for nontuberculous mycobacteria (NTM); OR - Biopsy showing mycobacterial histopathologic features (granulomatous inflammation or AFB) AND one or more sputum or bronchial washings that are culture positive for NTM - If the patient has an FDA-labeled indication, then ONE of the following: • Patient age is within FDA labeling for the requested indication; OR • There is support for using the requested agent for the patient’s age for the requested indication