Notes | Project documents | Elexacaftor, tezacaftor and ivacaftor fixed dose combination therapy for treating cystic fibrosis with the F508del mutation [ID1661] | Guidance

Following a request from Vertex Pharmaceuticals, we have had to reschedule this technology appraisal. Vertex has not provided NICE with an evidence submission by the deadline that took into account an expected licensing date towards the end of this calendar year. The appraisal cannot proceed without an evidence submission from the company. Vertex has indicated that it needs more time to allow for further data from the clinical and real world evidence studies to be included. They have committed to providing us with a full evidence submission by January 2021 at the latest. The first committee has been rescheduled to 12 August 2021 on this basis. We appreciate that this is very disappointing for those waiting with great anticipation for the triple therapy to become available, especially in the context of the coronavirus COVID-19 pandemic. Every week that goes by without an evidence submission from the company will lead to delay in the availability of NICE guidance. We will continue to work with Vertex on the evidence we need, and stand ready to receive their submission at the earliest opportunity between now and January 2021.