Symdeko (tezacaftor/ivacaftor and ivacaftor tablets) — Cigna

Cystic fibrosis

Initial criteria

Patient has a confirmed diagnosis of cystic fibrosis AND
Patient age ≥ 6 years AND
Patient has at least one pathogenic or likely pathogenic mutation in the cystic fibrosis transmembrane conductance regulator gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence AND
Patient has at least one of the following: positive cystic fibrosis newborn screening test OR family history of cystic fibrosis OR a clinical presentation consistent with signs and symptoms of cystic fibrosis AND
Patient has evidence of abnormal cystic fibrosis transmembrane conductance regulator function as demonstrated by at least one of the following: elevated sweat chloride test OR two cystic fibrosis-causing cystic fibrosis transmembrane conductance regulator mutations OR abnormal nasal potential difference AND
Medication is prescribed by or in consultation with a pulmonologist or physician who specializes in the treatment of cystic fibrosis

Patient continues to demonstrate clinical benefit from therapy as documented by the prescriber

12 months