vanzacaftor, tezacaftor, deutivacaftor

Proposed initiation and renewal criteria: In accordance with existing criteria for Trikafta. Proposed renewal criteria for patients switching from an existing CFTR modulator to Alyftrek: No decline in ppFEV1 compared with the baseline measurement; or No increase in the total number of days for which the patient received treatment with oral and/or IV antibiotics for pulmonary exacerbations in the previous 6 months compared with the 6-month period prior to initiating treatment; or no increase in the total number of pulmonary exacerbations requiring oral and/or IV antibiotics in the previous 6 months compared with the 6-month period prior to initiating treatment; or No decline in BMI or BMI z-score compared with the baseline BMI or BMI z-score; or No increase in the number of CF-related hospitalizations in the previous 6 months compared with the 6-month period prior to initiating treatment; or No reduction in the CFQ-R Respiratory Domain Score compared with baseline measurement; or Clinical benefit as determined by physician specializing in the treatment of CF.

For the treatment of cystic fibrosis (CF) in people aged 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene