Pharmacy Prior Authorization Criteria

Symdeko (tezacaftor/ivacaftor)

For diagnosis of Cystic Fibrosis (CF)
Indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.

*Please consult Background section for table of CFTR gene mutations responsive to Symdeko.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

AND

AND

Patient is homozygous for the F508del mutation in the CF transmembrane conductance regulator (CFTR) gene as detected by a U.S. Food and Drug Administration (FDA)-cleared cystic fibrosis mutation test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

Patient has at least one mutation in the CFTR gene that is responsive to tezacaftor/ivacaftor based in vitro data and/or clinical evidence* as detected by a U.S. Food and Drug Administration (FDA)-cleared cystic fibrosis mutation test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

AND

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

Patient demonstrates positive clinical response to therapy (e.g., improvement in lung function or decreased number of pulmonary exacerbations) [2,3]

2024-02-01, 2023-11-30, 2023-01-09, 2022-02-03, 2021-02-04, 2020-04-01, 2019-07-30

Symdeko Prescribing information. Vertex Pharmaceuticals Inc. Boston, MA. August 2023.
Cousar-Taylor J, Munch A, McKone E, et al. Tezacaftor-ivacaftor in patients with cystic fibrosis homozygous for phe508del. N Engl J Med. 2017; 1-11.
Rowe S, Daines C, Ringshausen F, et al. Tezacaftor-ivacaftor in residual-function heterozygotes with cystic fibrosis. N Engl J Med. 2017; 1-12.

2024-02-01: No criteria changes. Background and reference updates.
2023-11-30: Program update to standard reauthorization language. No changes to clinical intent.
2023-01-09: Annual review: No criteria changes.
2022-02-03: Annual review: no criteria changes
2021-02-04: 2021 Annual Review. Added background table and edited criteria to align with updated labeling including additional CFTR mutations.
2020-04-01: 2020 Annual Review; no changes to criteria
2019-07-30: 1) Modify PA due to expanded age: Treatment of patients with cystic fibrosis (CF) age 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. 2) New formulation: tezacaftor 50mg/ivacaftor 75mg and 75 mg - add to updated guideline"