Trikafta (elexacaftor/tezacaftor/ivacaftor tablets; ivacaftor tablets, co-packaged; elexacaftor/tezacaftor/ivacaftor oral granules; ivacaftor oral granules, co-packaged) — Cigna

Cystic Fibrosis

Initial criteria

Patient age ≥ 2 years
Patient has a confirmed diagnosis of cystic fibrosis
Patient has at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is considered pathogenic or likely pathogenic, or patient has one of the specified mutations listed in the policy
Patient meets at least ONE of the following: (i) Positive cystic fibrosis newborn screening test; OR (ii) Family history of cystic fibrosis; OR (iii) Clinical presentation consistent with signs and symptoms of cystic fibrosis (e.g., meconium ileus, sino-pulmonary symptoms, bronchiectasis, sinusitis, failure to thrive, pancreatic insufficiency)
Patient has evidence of abnormal CFTR function as demonstrated by at least ONE of the following: (i) Elevated sweat chloride test; OR (ii) Two cystic fibrosis-causing CFTR mutations; OR (iii) Abnormal nasal potential difference
Medication is prescribed by or in consultation with a pulmonologist or physician who specializes in the treatment of cystic fibrosis
Trikafta is not used in combination with other CFTR modulators (Alyftrek, Kalydeco, Orkambi, Symdeko)

Patient continues to meet initial criteria
Clinical benefit has been demonstrated or maintained
Trikafta continues to be prescribed by or in consultation with a pulmonologist or physician specializing in cystic fibrosis

12 months