The National Institute for Health and Care Excellence (NICE) has recommended Alyftrek® (deutivacaftor/tezacaftor/vanzacaftor) for eligible patients with cystic fibrosis (CF) on the NHS. This once-daily triple combination therapy, licensed in the UK in March 2025, is now available for individuals aged six years and older who carry at least one F508del mutation in the CFTR gene.
The approval follows NICE’s comparative review of Alyftrek and Kaftrio® (ivacaftor/tezacaftor/elexacaftor), which was recommended last year. According to NICE, clinical evidence shows Alyftrek to be similarly effective and cost-comparable to Kaftrio, offering patients another robust treatment option that addresses the root cause of CF rather than just managing its symptoms.
“CFTR modulators have already transformed cystic fibrosis care. We’re pleased to recommend Alyftrek, which offers significant benefits and continues this momentum,” said Helen Knight, Director of Medicines Evaluation, NICE.
Alyftrek is expected to benefit approximately 89% of people with CF in England, marking what Vertex International’s Senior VP, Ludovic Fenaux, called “a significant milestone” in the evolution of CF therapy. He highlighted that pivotal studies suggest Alyftrek could potentially deliver even better outcomes than Kaftrio.
Beyond the UK, deutivacaftor/tezacaftor/vanzacaftor will be available to eligible patients in Ireland, Denmark, and Germany, following recent European regulatory approval.
NICE’s final guidance on Alyftrek is anticipated by 30 July 2025.