NICE-wide topic prioritisation: the manual

12 NICE-wide 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. Requests for clarification do not usually offer an opportunity to revisit or overturn the NICE prioritisation board's decision, which is based on careful consideration of the evidence and relevance for future guidance development. Exceptions would be if 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 complete the clarification proforma within 20 working days of publication of the prioritisation board's decision. The questions will be reviewed, 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 considered at the next available NICE guidance executive meeting. The guidance executive will produce a final response within 10 working days after the meeting.

Clarifications and any final response from the guidance executive will be sent directly to the stakeholder using a standard template and published on the NICE website.