Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) — Medica

Cystic fibrosis

Initial criteria

Approve if ALL of the following are met (A, B, C, D, and E):
A) age ≥ 6 years; AND
B) patient has at least ONE pathogenic or likely pathogenic CFTR variant listed as responsive to Alyftrek (including but not limited to F508del or another responsive mutation); AND
C) patient meets at least ONE of the following (i, ii, or iii): 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); AND
D) patient has evidence of abnormal CFTR function demonstrated by at least ONE of the following (i, ii, or iii): i. elevated sweat chloride test; OR ii. two CF-causing CFTR mutations; OR iii. abnormal nasal potential difference; AND
E) medication is prescribed by or in consultation with a pulmonologist or physician who specializes in treatment of cystic fibrosis.

Reauthorization may be granted if patient continues to meet initial criteria and therapy remains clinically appropriate.

1 year