Draft guidance consultation
Closed for comments This consultation ended on at Request commenting lead permission
The Department of Health and Social Care has asked the National Institute for Health and Care Excellence (NICE) to produce guidance on using ivacaftor–tezacaftor–elexacaftor, tezacaftor–ivacaftor and lumacaftor–ivacaftor in the NHS in England. The evaluation committee has considered the evidence submitted by the company and the views of non-company stakeholders, clinical experts and patient experts.
This document has been prepared for consultation with the stakeholders. It summarises the evidence and views that have been considered, and sets out the recommendations made by the committee. NICE invites comments from the stakeholders for this evaluation and the public. This document should be read along with the evidence (see the committee papers).
The evaluation committee is interested in receiving comments on the following:
Has all of the relevant evidence been taken into account?
Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?
Are the recommendations sound and a suitable basis for guidance to the NHS?
Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?
Note that this document is not NICE's final guidance on these technologies. The recommendations in section 1 may change after consultation.
The evaluation committee will meet again to consider the evidence, this evaluation consultation document and comments from the stakeholders.
At that meeting, the committee will also consider comments made by people who are not stakeholders.
After considering these comments, the committee will prepare the final draft guidance.
Subject to any appeal by stakeholders, the final draft guidance may be used as the basis for NICE's guidance on using ivacaftor–tezacaftor–elexacaftor, tezacaftor–ivacaftor and lumacaftor–ivacaftor in the NHS in England.
The Scottish Medicines Consortium (SMC) will use the final recommendations to produce separate advice for the NHS health boards in Scotland.
For further details, see NICE's manual on health technology evaluation.
The key dates for this evaluation are:
Closing date for comments: 24 November 2023
Second evaluation committee meeting: 14 December 2023
Details of the evaluation committee are given in section 4