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DrugArikayce® (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


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

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