NICE integrated topic prioritisation and strategic principles
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9 Communicating prioritisation and routing decisions
All prioritisation decisions are shared with the Department of Health and Social Care (DHSC) and NHS England (NHSE) before publication on the NICE website.
NICE seeks a formal referral from DHSC or NHSE for new topics prioritised by the board.
The notifier (and person who suggested the topic to NICE, if these people are different) are informed about the prioritisation and routing decision.
NICE prioritisation board decisions are published on the NICE website with the:
topic name and identification number
decision (selected, further information needed, not selected)
brief rationale for the decision
date of the decision.
Topics that are not prioritised can be reconsidered if the NICE team is made aware of new information that addresses the reasons for non-selection, and more than 6 months have elapsed since the original decision was published.
Once a topic has been selected, it is scheduled for NICE guidance development, subject to formal referral from DHSC or NHSE in accordance with Regulation 5 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013. Topics including technologies that do not have UK regulatory approval or that have not been launched in the UK are scheduled so that the guidance publishes alongside or as early as possible after approval and launch. Technologies that already have UK regulatory approval and have been launched in the UK are scheduled for development as soon as is practical. Scheduling for development considers the existing NICE guidance development schedule and external factors such as ongoing studies to generate relevant evidence.
9.1 Integrated topic prioritisation clarification process
The aim of the clarification process is to explain NICE's reason for its prioritisation decision(s) that are queried by stakeholders. The request for clarification will not usually offer an opportunity to revisit or overturn the prioritisation board's decision, which is based on careful consideration of the evidence and relevance for future guidance development, unless substantial new information or factual errors come to light, or in the case of very rare disease, there is evidence that the highly specialised technologies routing criteria have not been appropriately applied. In exceptional circumstances, NICE may change its decision on the routing of new topics or updates following input from stakeholders, and will specify the rationale for this change.
The clarification process will be published on the NICE website and will apply to all topics and routing decisions that the prioritisation board considers.
Stakeholders should send questions for clarification by email to the NICE clinical directorate within 10 working days of publication of the prioritisation board's decision. The questions submitted will be reviewed by the topic prioritisation team in the clinical directorate and a response will be provided within 20 working days of the questions being received.
If a stakeholder returns with additional questions, these will be escalated and considered at the next available NICE guidance executive meeting. The guidance executive will direct a final response within 10 working days after the guidance executive meeting.
Clarifications and any final response from the guidance executive will be returned directly to the stakeholder using a standard template and published on the NICE website.
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