is now reimbursed for Australians with cystic fibrosis (CF) aged 6 years and older with at least one responsive mutation –
SYDNEY, Sunday 15th February 2026 – Vertex Pharmaceuticals today announced that as of 1 February 2026, ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor) will be funded on the Pharmaceutical Benefits Scheme (PBS) for the treatment of people aged 6 years and older with cystic fibrosis (CF) and who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is considered responsive, based on clinical or in vitro assay data[ii].
CF is a life-shortening, genetic disease affecting approximately 3,800 people in Australia[iii]. ALYFTREK is an innovative, once-daily, triple-combination CFTR modulator that targets the underlying cause of CF by improving the function of the faulty CFTR protein[iv]. It is the fifth CFTR modulator to be made available in Australia, but the first once-daily option, simplifying treatment for patients.
"The PBS listing for ALYFTREK represents a significant milestone in our journey to serially innovate and further improve the lives of people living with cystic fibrosis. Today, more than 95% of Australians living with cystic fibrosis now have access to a CFTR modulator," said Elisha Whitfield, Senior Country Manager of Vertex Pharmaceuticals ANZ.
The PBS listing of ALYFTREK is based on global clinical trials that assessed its safety and efficacy in people with CF aged 6 years and over, supported by real-world evidence and in vitro data. Detailed information on side effects, precautions, and dosing is available in the Consumer Medicine Information (CMI).
Patients and caregivers should speak with their treating healthcare professional to understand if ALYFTREK may be suitable for them.
PBS Information: ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor) will be available on the Pharmaceutical Benefits Scheme (PBS) for the treatment of CF in people aged 6 years and older with at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is considered responsive based on clinical or in vitro assay data from 1 February 2026. |
About Cystic Fibrosis
Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 112,000 people, including 3,800 people in Australia. CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF, and these mutations can be identified by a genetic test. While there are many different types of CFTR mutations that can cause the disease, the vast majority of people with CF have at least one F508del mutation. CFTR mutations lead to CF by causing CFTR protein to be defective or by leading to a shortage or absence of CFTR protein at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus, chronic lung infections and progressive lung damage that eventually leads to death for many patients.
Today Vertex CF medicines are treating over 75,000 people with CF across more than 60 countries on six continents. This represents 2/3 of the diagnosed people with CF eligible for CFTR modulator therapy.
Diagnosis of CF is often made by genetic testing and is confirmed by testing sweat chloride (SwCl), which measures CFTR protein dysfunction. The diagnostic threshold for CF is SwCl ≥60 mmol/L, while levels between 30-59 indicate CF is possible and more testing may be needed to make the diagnosis of CF.
Higher levels of SwCl are associated with more severe disease. People with SwCl levels below 60 mmol/L have better lung function, fewer pulmonary exacerbations, better quality of life, and improved survival than those with higher levels of SwCl. Restoring SwCl levels below 30 mmol/L has long been the ultimate treatment goal for Vertex, as levels below 30 mmol/L are considered normal and are typical of CF carriers who do not have disease.
About ALYFTREK® (vanzacaftor/tezacaftor/deutivacaftor)
The following information is an excerpt from the ALYFTREK Product Information (PI). Please refer to the full PI
