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

Initial criteria

• Diagnosis of Mycobacterium avium complex (MAC) lung disease confirmed by BOTH clinical and microbiological findings:
• • Clinical findings – at least ONE of: pulmonary or systemic symptoms; nodular or cavitary opacities on chest radiograph; high-resolution computed tomography showing multifocal bronchiectasis with multiple small nodules AND
• • Microbiological findings – at least ONE of: positive culture results from two separate expectorated sputum samples; positive culture from at least one bronchial wash or lavage; transbronchial or other lung biopsy with mycobacterial histopathologic features (granulomatous inflammation or acid-fast bacilli) and positive culture for nontuberculous mycobacteria; biopsy showing mycobacterial histopathologic features and one or more sputum or bronchial washings culture-positive for nontuberculous mycobacteria AND
• Patient age is within FDA labeling for the requested indication OR there is support for use in that age group for the requested indication AND
• Patient has positive sputum cultures despite ≥6 consecutive months of guideline-based combination antibiotic therapy for MAC lung disease (may include macrolide [clarithromycin, azithromycin], rifamycin [rifampin, rifabutin], and ethambutol) AND
• Patient will continue guideline-based combination antibiotic therapy for MAC lung disease with the requested agent AND
• Prescriber is a specialist (infectious disease, immunologist, pulmonologist, thoracic specialist) or has consulted with such a specialist AND
• ONE of the following regarding inhaled antibiotics applies:
• • Patient is NOT currently treated with another inhaled antibiotic (e.g., aztreonam inhalation, tobramycin inhalation) OR
• • Patient is currently treated with another inhaled antibiotic AND (will discontinue the other inhaled antibiotic prior to starting the requested agent OR there is support for concurrent use) AND
• Patient does NOT have any FDA labeled contraindications to the requested agent
• For members residing in Ohio with Fully Insured or HIM Shop (SG) plans – criteria also may be met when:
• • Patient has no FDA labeled contraindications AND (has another FDA labeled indication for the requested agent/route OR has a compendia supported indication OR prescriber submits two peer-reviewed journal articles supporting use)

Reauthorization criteria

• Patient was previously approved for the requested agent through plan prior authorization AND
• Patient has had clinical benefit with the requested agent AND
• Patient will continue treatment with guideline-based combination antibiotic therapy for Mycobacterium avium complex (MAC) lung disease AND
• Prescriber is a specialist (infectious disease, immunologist, pulmonologist, thoracic specialist) or has consulted with such a specialist AND
• ONE of the following regarding inhaled antibiotics applies:
• • Patient is NOT currently treated with another inhaled antibiotic (e.g., aztreonam inhalation, tobramycin inhalation) OR
• • Patient is currently treated with another inhaled antibiotic AND (will discontinue the other inhaled antibiotic prior to starting the requested agent OR there is support for concurrent use) AND
• Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months