Arikayce®

Drug - Arikayce® (amikacin suspension) [Insmed Incorporated]

June 2019

Therapeutic area - Inhaled Antibiotics

Initial approval criteria

Patient is ≥ 18 years of age AND
Diagnosis of Mycobacterium avium complex (MAC) lung disease as determined by the following:
- chest radiography or high-resolution computed tomography (HRCT) scan AND
- at least 2 positive sputum cultures AND
- other conditions such as tuberculosis and lung malignancy have been ruled out AND
Patient has failed a multi-drug regimen with a macrolide (clarithromycin or azithromycin), rifampin, and ethambutol. (Failure is defined as continual positive sputum cultures for MAC while adhering to a multi-drug treatment regimen for a minimum duration of 6 months) AND
Patient has documented failure or intolerance to aerosolized administration of amikacin solution for injection, including pretreatment with a bronchodilator AND
Arikayce will be prescribed in conjunction with a multi-drug antimycobacterial regimen
Initial approval is for 6 months

Patient has demonstrated response to therapy with the addition of Arikayce, as defined as 3 consecutive monthly negative sputum cultures starting by month 6 of treatment AND
Patient has not experienced toxicity to amikacin treatment (e.g., ototoxicity, renal toxicity, neuromuscular blockade)
Renewal approval is for 6 months

MHCP Provider Call Center 651-431-2700 or 800-366-5411