NICE Ruxolitinib (Opzelura) appraisal update (May 2024)
The National Institute for Health and Care Excellence (NICE) are currently appraising the clinical and cost effectiveness of Ruxolitinib within its marketing authorisation for treating non-segmental vitiligo in people 12 years and over. The importance of this is that, if approved, it could make Ruxolitinib available on the NHS.
11th January 2024 Technology Appraisal Committee Meeting
The appraisal was discussed by the technology appraisal committee on 11th January 2024. The appraisal committee reached a conclusion not to recommend ruxolitinib, within its marketing authorisation, for treating non-segmental vitiligo with facial involvement in people aged 12 years and over.
The detail of the appraisal committee discussion and preliminary recommendation will be provided in Draft Guidance. Only participating consultees, commentators and experts are informed of the committee decision, under the terms of the appraisal confidentiality agreement. This information remains confidential until publication of the document on the NICE website. So, at this point we cannot provide insight on why this decision was reached however, based on what we observed from the public meeting, we believe it is likely linked to the proposed cost of the treatment, rather than the perceived need for more treatment options.
What is the significance of this decision?
Although the status is that a recommendation has not been made at this stage, it’s by no means a final decision. Stakeholders will have the opportunity to feedback on the process, including the summaries of clinical and cost effectiveness; providing insight as to whether all the relevant evidence has been considered; and if the recommendations are sound and a suitable basis for guidance to the NHS. Current statistics on the NICE site state that 84% of their final appraisal recommendations are positive ones – so there is still a good chance that the initial decision may be reversed.
What happens next?
NICE has invited comments from the stakeholders and the public. The NICE evaluation committee has invited 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?
These comments are now being reviewed along with submission from stakeholders, and the recommendations in section 1 may change as a result of this and the next stages of the consultation.
The evaluation committee will meet again to consider the evidence, this evaluation consultation document and comments from the stakeholders. At that meeting, now scheduled for the 6th June 2024, the committee will also consider comments made by people who are not stakeholders and 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 ruxolitinib in the NHS in England.
The key dates for this evaluation are:
- Details to register to observe the second committee meeting in June will be available on the NICE Meetings in public webpage from mid May 2024.
- Second evaluation committee meeting: 6 June 2024
- You can register directly to attend the meeting on the 6 June by following this link
Incyte can be contacted via telephone for any questions relating to the treatment and its availability: https://incyte.com/contact-us/medical-information
Funding disclosure:
The Vitiligo Society has project work supported by an educational grant from Incyte Biosciences UK Ltd. The Vitiligo Society maintains full control over the all project management and content, ensuring independence and impartiality in its work.
When it comes to any external funding we follow the current guidance and rules as set out by the Charity Commission and the Fundraising Regulator. We report any research collaborations and/or financial contributions received from industry in our annual reports and accounts as well as being transparent about our partnerships on our website.
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