Arikayce (amikacin liposome suspension for oral inhalation – Insmed) — Cigna

Initial criteria

• Age ≥ 18 years; AND
• Patient has completed ≥ 6 consecutive months of a background multidrug regimen (typically includes a macrolide [azithromycin or clarithromycin], ethambutol, and a rifamycin [rifampin or rifabutin]); AND
• Patient has a positive sputum culture for Mycobacterium avium complex obtained after ≥ 6 consecutive months of background regimen; AND
• The Mycobacterium avium complex isolate is susceptible to amikacin according to laboratory report; AND
• Medication will be used in conjunction with a background multidrug regimen (macrolide, ethambutol, and rifamycin); AND
• Prescribed by a pulmonologist, infectious diseases physician, or physician specializing in treatment of Mycobacterium avium complex lung infections.

Reauthorization criteria

• Medication will be used in conjunction with a background multidrug regimen (macrolide, ethambutol, and rifamycin); AND
• Patient meets ONE of the following: (a) patient has not achieved negative sputum cultures for Mycobacterium avium complex; OR (b) patient has achieved negative sputum cultures for Mycobacterium avium complex for less than 12 months (approve enough to complete 12 months of therapy following a negative sputum culture).

Approval duration

1 year