Arikayce — Blue Cross Blue Shield of Oklahoma

Initial criteria

• The patient has a diagnosis of Mycobacterium avium complex (MAC) lung disease confirmed by BOTH of the following: (A) at least ONE clinical finding (pulmonary or systemic symptoms; nodular or cavitary opacities on chest radiograph; high-resolution CT scan showing multifocal bronchiectasis with multiple small nodules) AND (B) at least ONE microbiological finding (positive culture results from at least two separate expectorated sputum samples; positive culture from at least one bronchial wash or lavage; transbronchial or other lung biopsy with mycobacterial histopathologic features and positive culture for nontuberculous mycobacteria; biopsy showing mycobacterial histopathologic features and one or more sputum or bronchial washings culture positive for NTM)
• If FDA labeled indication, patient’s age is within labeling OR supported for age for requested indication
• Patient has positive sputum cultures despite ≥ 6 consecutive months of guideline-based combination antibiotic therapy for MAC lung disease (e.g., macrolide [clarithromycin, azithromycin], rifamycin [rifampin, rifabutin], ethambutol)
• Patient will continue treatment with guideline-based combination antibiotic therapy for MAC lung disease (e.g., macrolide, rifamycin, ethambutol) concurrently with requested agent
• Prescriber is a specialist (infectious disease, immunologist, pulmonologist, thoracic specialist) or has consulted with such specialist
• ONE of the following: (A) Patient is NOT currently treated with another inhaled antibiotic (e.g., aztreonam for inhalation, tobramycin for inhalation) OR (B) Patient is currently treated with another inhaled antibiotic AND will discontinue prior to starting requested agent OR there is support for concomitant use
• Patient does NOT have any FDA labeled contraindications to requested agent

Reauthorization criteria

• Patient previously approved for requested agent through 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 requested agent (e.g., macrolide, rifamycin, ethambutol)
• Prescriber is a specialist (infectious disease, immunologist, pulmonologist, thoracic specialist) or has consulted with such specialist
• ONE of the following: (A) Patient is NOT currently treated with another inhaled antibiotic (e.g., aztreonam for inhalation, tobramycin for inhalation) OR (B) Patient is currently treated with another inhaled antibiotic AND will discontinue prior to starting requested agent OR there is support for concomitant use
• Patient does NOT have any FDA labeled contraindications to requested agent

Approval duration

12 months