Following the consultation, which BIVDA responded to, NICE has confirmed that they will proceed with changes to the appeal process for NICE’s technology appraisal (TA) and highly specialised technologies (HST) as outlined in the final draft guidance.
For final draft guidance, that guidance now recommends a technology can be used (including as an option or during a managed access period as an option), a consultee who intends to submit an appeal, or is considering submitting an appeal, must notify NICE within the first 5 working days of the appeal period. The consultee would then have until the end of the 15 working day appeal period to submit the appeal.
Notifying NICE of an intention to appeal would not commit a consultee to submit an appeal. However, a consultee would be unable to submit an appeal if they had not notified NICE of an intention to appeal within the initial 5 working days deadline. The period highlighting factual errors will also be reduced to 5 working days.
These arrangements will also apply when the guidance recommends a technology can be used and NICE has agreed to vary the funding requirement.
The arrangements remain unchanged when the final draft guidance does not recommend a technology. There will be no requirement to notify NICE of an intention to appeal within the first 5 working days of the appeal period.
By making this change NICE will be able to publish guidance that enables access to new treatments 2 weeks faster (if no notifications of an intention to appeal are received).
The updated process guide can be found here. The updated appeal period will apply to all final draft guidance issued on or after 1 June 2025. The letter to stakeholders that accompanies each final draft guidance will clearly state the appeal and factual accuracy deadlines for the topic.
