Kalydeco — Cigna

Initial criteria

• Patient has a diagnosis of cystic fibrosis
• Patient age ≥ 1 month
• Patient has one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to Kalydeco based on clinical and/or in vitro assay data
• Patient has at least one of the following: positive cystic fibrosis newborn screening test OR family history of cystic fibrosis OR clinical presentation consistent with signs and symptoms of cystic fibrosis
• Patient has evidence of abnormal CFTR function demonstrated by at least one of the following: elevated sweat chloride test OR two cystic fibrosis–causing CFTR mutations OR abnormal nasal potential difference
• Kalydeco is not used in combination with another CFTR modulator (e.g., Alyftrek, Orkambi, Symdeko, Trikafta)