Kalydeco (ivacaftor) — United Healthcare
Cystic fibrosis (CF) in patients aged 1 month and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data
Initial criteria
- Diagnosis of cystic fibrosis (CF)
- Submission of laboratory results confirming that patient has at least one of the CFTR gene mutations responsive to Kalydeco as listed in the Prescribing Information
- Prescribed by or in consultation with a provider who specializes in the treatment of CF
Reauthorization criteria
- Documentation of positive clinical response to Kalydeco therapy (e.g., improved lung function, stable lung function)
Approval duration
12 months