Pharmacy Prior Authorization Criteria

Arikayce (amikacin liposome inhalation suspension)

For diagnosis of Mycobacterium avium complex
Indicated in adults who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Mycobacterium avium complex (MAC) lung disease

AND

Requested drug will be used alongside a combination antibacterial drug regimen (e.g., clarithromycin, rifampin and ethambutol)

AND

Patient has received a minimum of 6 consecutive months of a multidrug background regimen therapy (e.g., a macrolide, a rifamycin, ethambutol, etc.) before starting therapy with the requested drug

AND

Patient has not achieved at least two negative sputum cultures following this treatment regimen [1,2]

AND

2024-08-06, 2023-08-22, 2022-09-14, 2021-08-04, 2020-08-17, 2020-08-06

Arikayce Prescribing Information. Insmed, Bridgewater, NJ. February 2023.
Daley CL, Iaccarino JM, Lange C, et al. Treatment of nontuberculous mycobacterial pulmonary disease: an official ATS/ERS/ESCMID/IDSA clinical practice guideline. Eur Respir J. 2020;56(1):2000535.