Symdeko (tezacaftor/ivacaftor) — United Healthcare

Initial criteria

• Diagnosis of cystic fibrosis (CF)
• AND One of the following:
• Documentation confirming the patient is homozygous for the F508del mutation in the CFTR gene
• OR Documentation confirming the patient has at least one mutation in the CFTR gene that is responsive to Symdeko (see list of responsive mutations in prescribing information)

Reauthorization criteria

• Documentation of positive clinical response to Symdeko therapy (e.g., improved lung function, stable lung function)

Approval duration

12 months