amikacin sulfate liposome inhalation suspension — Blue Cross Blue Shield of Illinois

Initial criteria

• Diagnosis of Mycobacterium avium complex (MAC) lung disease as confirmed by BOTH clinical and microbiological findings:
• • Clinical findings: at least one of the following—pulmonary or systemic symptoms; nodular or cavitary opacities on chest radiograph; high-resolution CT showing multifocal bronchiectasis with multiple small nodules AND
• • Microbiological findings: at least one of the following—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 FDA-labeled indication: patient’s age is within FDA labeling OR there is support for use in 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 (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
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., infectious disease, immunologist, pulmonologist, thoracic specialist) or has consulted with such specialist
• ONE of the following: (A) patient is NOT currently being treated with another inhaled antibiotic (e.g., aztreonam for inhalation, tobramycin for inhalation) OR (B) patient is currently being treated with another inhaled antibiotic AND (1) the patient will discontinue the other inhaled antibiotic prior to starting the requested agent OR (2) there is support for concurrent use
• Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• Patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• Patient has had clinical benefit with the requested agent
• Patient will continue treatment with guideline-based combination antibiotic therapy for MAC lung disease with the requested agent
• Prescriber is a specialist in the area of the patient’s diagnosis or has consulted with such specialist
• ONE of the following: (A) patient is NOT currently being treated with another inhaled antibiotic (e.g., aztreonam for inhalation, tobramycin for inhalation) OR (B) patient is currently being treated with another inhaled antibiotic AND (1) the patient will discontinue the other inhaled antibiotic prior to starting the requested agent OR (2) there is support for concurrent use
• Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months