amikacin sulfate liposome — Blue Cross Blue Shield of Texas

Initial criteria

• 1. Diagnosis of Mycobacterium avium complex (MAC) lung disease confirmed by BOTH of the following (medical records including chart notes required):
• A. At least ONE clinical finding: pulmonary or systemic symptoms; nodular or cavitary opacities on chest radiograph; or high-resolution computed tomography showing multifocal bronchiectasis with multiple small nodules AND
• B. At least ONE microbiological finding: positive culture results from ≥2 separate expectorated sputum samples; OR positive culture result from ≥1 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 AND
• 2. If the patient has an FDA labeled indication, then ONE of the following:
• A. Age is within FDA labeling for the requested indication OR
• B. There is support for use for the patient's age for the requested indication AND
• 3. Positive sputum cultures despite ≥6 consecutive months of treatment with guideline-based combination antibiotic therapy for MAC lung disease (e.g., macrolide [clarithromycin, azithromycin], rifamycin [rifampin, rifabutin], and ethambutol) AND
• 4. Will continue treatment with guideline-based combination antibiotic therapy for MAC lung disease with the requested agent AND
• 5. Prescriber is a specialist (infectious disease, immunologist, pulmonologist, thoracic specialist) or has consulted one AND
• 6. ONE of the following:
• A. Not currently being treated with another inhaled antibiotic (e.g., aztreonam for inhalation, tobramycin for inhalation) OR
• B. Currently being treated with another inhaled antibiotic AND ONE of the following:
• 1. Will discontinue the other inhaled antibiotic prior to starting the requested agent OR
• 2. There is support for the concurrent use of another inhaled antibiotic with the requested agent AND
• 7. No FDA labeled contraindications to the requested agent

Reauthorization criteria

• 1. Previously approved for the requested agent through the plan’s Prior Authorization process AND
• 2. Has had clinical benefit with the requested agent AND
• 3. Will continue treatment with guideline-based combination antibiotic therapy for Mycobacterium avium complex (MAC) lung disease (e.g., macrolide [clarithromycin, azithromycin], rifamycin [rifampin, rifabutin], and ethambutol) AND
• 4. Prescriber is a specialist (infectious disease, immunologist, pulmonologist, thoracic specialist) or has consulted one AND
• 5. ONE of the following:
• A. Not currently being treated with another inhaled antibiotic (e.g., aztreonam for inhalation, tobramycin for inhalation) OR
• B. Currently being treated with another inhaled antibiotic AND ONE of the following:
• 1. Will discontinue the other inhaled antibiotic prior to starting the requested agent OR
• 2. There is support for the concurrent use of another inhaled antibiotic with the requested agent AND
• 6. No FDA labeled contraindications to the requested agent

Approval duration

12 months