Symdeko (tezacaftor/ivacaftor and ivacaftor) — Medical Mutual

Initial criteria

• Patient is age ≥ 6 years; AND
• Symdeko is prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of Cystic Fibrosis (CF); AND
• Patient meets ONE of the following (i or ii): i. Patient has 2 copies of the F508del mutation; OR ii. Patient has at least one mutation of the cystic fibrosis transmembrane conductance regulator (CFTR) gene that laboratory testing shows is susceptible to treatment with Symdeko; AND
• 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; AND
• Patient has evidence of abnormal CFTR function as 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

Approval duration

6 months