Prior Authorization Criteria for Approval

Initial Evaluation

Arikayce will be approved when ALL of the following are met:

1. The patient has a diagnosis of Mycobacterium avium complex (MAC) lung disease
   AND
2. The patient has not achieved negative sputum cultures despite at least 6 consecutive months of treatment with standard combination antibiotic therapy for MAC lung disease [e.g., standard combination may include a macrolide (clarithromycin, azithromycin), a rifamycin (rifampin, rifabutin), and ethambutol]
   AND
3. The patient will continue treatment with a combination antibiotic therapy for MAC lung disease with the requested medication [e.g., combination may include a macrolide (clarithromycin, azithromycin), a rifamycin (rifampin, rifabutin), and ethambutol]
   AND
4. 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
   AND
5. ONE of the following:
   1. The requested quantity (dose) does NOT exceed the program quantity limit
      OR
   2. BOTH of the following:
      1. The requested quantity (dose) is greater than the program quantity limit
         AND
      2. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months

Renewal Evaluation

Arikayce will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria
   AND
2. The patient has a diagnosis of Mycobacterium avium complex (MAC) lung disease
   AND
3. The patient has had clinical benefit with the requested medication
   AND
4. The patient will continue treatment with a combination antibiotic therapy for MAC lung disease with the requested medication [e.g., combination may include a macrolide (clarithromycin, azithromycin), a rifamycin (rifampin, rifabutin), and ethambutol]
   AND
5. 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
   AND
6. ONE of the following:
   1. The requested quantity (dose) does NOT exceed the program quantity limit
      OR
   2. BOTH of the following:
      1. The requested quantity (dose) is greater than the program quantity limit
         AND
      2. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months