Arikayce (amikacin liposome inhalation suspension) — United Healthcare

Initial criteria

• Diagnosis of refractory Mycobacterium avium complex (MAC) lung disease
• Submission of medical records documenting respiratory cultures positive for MAC within the previous 6 months
• Submission of medical records documenting the patient has been receiving a multidrug background regimen containing at least two of the following agents for a minimum of 6 consecutive months within the past 12 months: macrolide antibiotic (e.g., azithromycin, clarithromycin), ethambutol, rifamycin antibiotic (e.g., rifampin, rifabutin)
• Patient will continue to receive a multidrug background regimen
• Documentation that the patient has not achieved negative sputum cultures after receipt of a multidrug background regimen for a minimum of 6 consecutive months
• In vitro susceptibility testing of recent (within 6 months) positive culture documents that the MAC isolate is susceptible to amikacin with a minimum inhibitory concentration (MIC) of < 64 mcg/mL
• Prescribed by or in consultation with an infectious disease specialist or pulmonologist

Reauthorization criteria

• One of the following: Documentation that the patient has achieved negative respiratory cultures OR all of the following: patient has not achieved negative respiratory cultures while on Arikayce AND physician attestation that patient has demonstrated clinical benefit while on Arikayce AND in vitro susceptibility testing of most recent (within 6 months) positive culture documents that the MAC isolate is susceptible to amikacin with a MIC < 64 mcg/mL AND patient has not received greater than 12 months of Arikayce therapy with continued positive respiratory cultures
• Submission of medical records documenting that the patient continues to receive a multidrug background regimen containing at least two of the following agents: macrolide antibiotic (e.g., azithromycin, clarithromycin), ethambutol, rifamycin antibiotic (e.g., rifampin, rifabutin)
• Prescribed by or in consultation with an infectious disease specialist or pulmonologist

Approval duration

6 months