ARIKAYCE (amikacin)

ARIKAYCE (amikacin) 

SELF ADMINISTRATION- INHALATION SUSPENSION

Indications for Prior Authorization:

• Indicated in adults who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy

Patients must meet the following criteria for the indication(s) above:

• Patient is 18 years of age or older, AND
• Diagnosis of Mycobacterium avium complex (MAC) lung disease confirmed by chart note documentation, AND
• Prescribed by or in consultation with an infectious disease specialist or pulmonologist, AND
• Failure (confirmed by a positive sputum culture) of at least a 6-month trial of a multidrug background regimen therapy at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced, AND
• Arikayce® should be used with background multidrug regimen (including a macrolide [azithromycin or clarithromycin], ethambutol, and a rifamycin [rifampin or rifabutin])

Dosing: 

• Inhale 1 vial (590mg/8.4mL) once daily
• For oral inhalation use only
• Use Arikayce® vials only with the Lamira Nebulizer System
• Consider pre-treatment with inhaled bronchodilator in patients with a history of hyperreactive airway disease

Approval: 

• 1 year