lumacaftor/ivacaftor — United Healthcare
cystic fibrosis (CF) in patients homozygous for the F508del mutation in the CFTR gene
Initial criteria
- Diagnosis of cystic fibrosis (CF)
- Documentation confirming the patient is homozygous for the F508del mutation in the CFTR gene
- age ≥ 1 years
Reauthorization criteria
- Documentation of positive clinical response to Orkambi therapy (e.g., improved lung function, stable lung function)
Approval duration
12 months