Symdeko (tezacaftor/ivacaftor and ivacaftor) — Medica

Cystic fibrosis

Initial criteria

Patient is age ≥ 6 years
Patient meets ONE of the following: (i) has at least ONE pathogenic or likely pathogenic CFTR mutation responsive to Symdeko as listed in policy Table 1; OR (ii) has TWO copies of the F508del mutation
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 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 a physician who specializes in the treatment of cystic fibrosis

1 year