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  • Question on Consultation

    What best describes your background? a) Patient group b) Company c) Professional group d) Other (please state)

  • Question on Consultation

    Have you been involved in submitting an appeal before?

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    Please comment on the proposed changes

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    Please comment on the proposed timescale for implementing the changes
The content on this page is not current guidance and is only for the purposes of the consultation process.

Proposed changes to the appeal period for technology appraisal and highly specialised technologies final draft guidance

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Background

In accordance with our statutory framework, consultees can appeal against a technology appraisal (TA) recommendation or a highly specialised technology (HST) recommendation on the grounds that:

  1. in making the assessment that preceded the recommendation, NICE:

    1. failed to act fairly, or

    2. exceeded its powers; or

  2. the recommendation is unreasonable in the light of the evidence submitted to NICE.

NICE's guide to the technology appraisal and highly specialised technologies appeal process sets out the arrangements for making and hearing appeals. It states that consultees have 15 working days from receiving the final draft guidance in which to submit an appeal.

Proposed changes

We propose amending the appeal process so that a consultee who intends to submit an appeal, or is considering submitting an appeal, against final draft guidance that recommends a technology can be used must notify NICE within the first 5 working days of the appeal period.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 days appeal period to submit the appeal.

Notifying NICE of an intention to appeal would not commit a consultee to submitting an appeal. But a consultee would be unable to submit an appeal if they had not notified NICE of an intention to appeal within the first 5 working days deadline.

These changes would only apply when the final draft guidance recommends the technology can be used, including during a managed access period. It would also apply when the guidance states a technology can be used and NICE has agreed to vary the funding requirement.

The appeal arrangements would remain unchanged when the final draft guidance recommends the technology should not be used or more research is needed. So, a consultee would still have the full 15 working days appeal period to consider whether to submit an appeal and to do so. There would be no requirement to notify NICE of an intention to appeal in the first 5 working days.

The email to consultees from NICE that accompanies the final draft guidance would confirm the notification and appeal deadlines.

The changes relate to the appeal process only. They do not affect any arrangements in place for the interim funding of particular technologies prior to publication of final draft guidance, including through the Cancer Drugs Fund. 

Why we are proposing this change

Appeals are an important part of the guidance development process but are infrequent. Most guidance does not receive an appeal. Between 1 March 2019 and 31 March 2024, NICE published 416 pieces of TA and HST guidance (including terminations) and received appeals on 30 final draft guidance documents. These were usually related to guidance that did not recommend the technology (23 of the 30 appeals).

Our core purpose is to help practitioners and commissioners get the best care to patients, fast, while ensuring value for the taxpayer. By making this change, we will be able to publish guidance that enables access to new treatments 2 weeks faster than currently (if no notifications of an intention to appeal are received). The change is only proposed when guidance recommends a technology can be used, because timeliness is even more critical in this scenario and these recommendations are less likely to be appealed. The current arrangements would still apply for challenging final draft guidance that recommends a technology should not be used or more research is needed.

Next steps after the consultation

After the consultation, we will carefully consider the feedback and decide on the next steps. If NICE decides to proceed with changes to the appeal process, we will publish an amended guide to the technology appraisal and highly specialised technologies appeal process. This would apply to appeals against any final draft guidance issued to stakeholders 2 months after the amended guide is published.

Associated changes to the process for correcting factual errors in final draft guidance

During the current 15 working days appeal period there is a separate opportunity for stakeholders to highlight any factual errors in the final draft guidance. To enable guidance that recommends a technology to publish 2 weeks faster than currently it is necessary to maintain alignment between the appeals and factual accuracy processes. So, we propose that stakeholders will in future have 5 working days to highlight factual errors in final draft guidance that recommends a technology can be used, including during a managed access period and where NICE has agreed to vary the funding requirement.

Stakeholders would continue to have 15 working days to highlight factual errors in final draft guidance that recommends a technology should not be used or more research is needed.