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
Renewal criteria
- 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
Quantity limits
- 1 kit (28 doses) per 28 days
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411