Arikayce (amikacin liposome suspension for oral inhalation) — Medica

Initial criteria

• age > 18 years
• completed > 6 consecutive months of a background multidrug regimen (typically includes a macrolide [azithromycin or clarithromycin], ethambutol, and a rifamycin [rifampin or rifabutin])
• positive sputum culture for Mycobacterium avium complex collected within the past 3 months after completing ≥ 6 consecutive months of a background multidrug regimen
• Mycobacterium avium complex isolate is susceptible to amikacin per laboratory report
• Arikayce will be used in conjunction with a background multidrug regimen (typically includes a macrolide, ethambutol, and a rifamycin)
• prescribed by or in consultation with a pulmonologist, infectious diseases physician, or physician specializing in MAC lung infections

Reauthorization criteria

• Arikayce will be used in conjunction with a background multidrug regimen (typically includes a macrolide, ethambutol, and a rifamycin)
• Approve for 1 year if patient has not achieved negative sputum cultures for MAC OR approve for 1 year (total) if patient has achieved negative sputum cultures for less than 12 months (approve enough to complete 12 months of therapy following a negative sputum culture)

Approval duration

1 year