Arikayce — Blue Cross Blue Shield of Alabama

Initial criteria

• The 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)
• The 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)
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., infectious disease, immunologist, pulmonologist, thoracic specialist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
• ONE of the following: - The patient is NOT currently being treated with another inhaled antibiotic (e.g., aztreonam for inhalation, tobramycin for inhalation) OR - The patient is currently being treated with another inhaled antibiotic AND ONE of the following: • The patient will discontinue the other inhaled antibiotic prior to starting the requested agent OR • There is support for the use of another inhaled antibiotic concurrently with the requested agent
• The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• The patient has had clinical benefit with the requested agent
• The patient will continue treatment with guideline-based combination antibiotic therapy for Mycobacterium avium complex (MAC) lung disease with the requested agent (e.g., combination may include a macrolide [clarithromycin, azithromycin], a rifamycin [rifampin, rifabutin], and ethambutol)
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., infectious disease, immunologist, pulmonologist, thoracic specialist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
• ONE of the following: - The patient is NOT currently being treated with another inhaled antibiotic (e.g., aztreonam for inhalation, tobramycin for inhalation) OR - The patient is currently being treated with another inhaled antibiotic AND ONE of the following: • The patient will discontinue the other inhaled antibiotic prior to starting the requested agent OR • There is support for the use of another inhaled antibiotic concurrently with the requested agent
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months