amikacin liposome inhalation suspension — Blue Cross Blue Shield of Kansas

Initial criteria

• Diagnosis of Mycobacterium avium complex (MAC) lung disease confirmed by BOTH of the following:
• A. At least ONE of the following clinical findings: pulmonary or systemic symptoms; nodular or cavitary opacities on chest radiograph; a high-resolution computed tomography scan that shows multifocal bronchiectasis with multiple small nodules
• B. At least ONE of the following microbiological findings: positive culture results from at least two separate expectorated sputum samples; positive culture result from at least one bronchial wash or lavage; transbronchial or other lung biopsy with mycobacterial histopathologic features (granulomatous inflammation or acid-fast bacilli [AFB]) AND positive culture for nontuberculous mycobacteria (NTM); 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: (A) The patient’s age is within FDA labeling for the requested indication for the requested agent OR (B) There is support for using the requested agent for the patient’s age for the requested indication
• Patient has positive sputum cultures despite at least 6 consecutive months of treatment with guideline-based combination antibiotic therapy for MAC lung disease (e.g., standard combination may include a macrolide [clarithromycin, azithromycin], a rifamycin [rifampin, rifabutin], and ethambutol)
• Patient will continue treatment with guideline-based combination antibiotic therapy for MAC lung disease with the requested agent (e.g., combination may include a macrolide [clarithromycin, azithromycin], a rifamycin [rifampin, rifabutin], and ethambutol)