lumacaftor/ivacaftor — United Healthcare

Initial criteria

• Diagnosis of cystic fibrosis (CF)
• Submission of laboratory results confirming that patient is homozygous for the F508del mutation in the CFTR gene
• age ≥ 1 years
• Prescribed by or in consultation with a provider who specializes in the treatment of CF

Reauthorization criteria

• Documentation of positive clinical response to Orkambi therapy (e.g., improved lung function, stable lung function)

Approval duration

12 months