The methods, processes and topic selection manuals cover:
- how we choose medicines and other health technologies to evaluate (topic selection)
- the steps and stages in each evaluation (our processes)
- how we collect and consider evidence (our methods).
The new methods and processes are used for all new evaluations starting from 1 February 2022.
What's changed and why
The changes we've made aim to streamline and improve the way we carry out health technology evaluation. We've now produced a single guidance development manual, covering:
- diagnostic assessment
- highly specialised technologies
- medical technologies evaluation
- technology appraisal.
We've also developed a new topic selection manual.
Changes we've made
We've made a broad range of improvements to how we evaluate health technologies, including:
- We'll give more weight to health benefits in the most severe conditions. We've made this change because evidence shows that people in the UK value access to treatments for the most severe diseases.
- We're adopting a new approach to the evidence we consider in our assessments.
- We’re allowing more flexibility for NICE’s independent committees in cases when generating evidence is difficult.
- We’ve adopted a clearer vision, principles and routing criteria for treatments for very rare diseases in our Highly Specialised Technologies (HST) Programme.
- We're aligning our methods and processes across different types of evaluations. This will ensure that the way we evaluate health technologies is pragmatic, agile and robust, while also being adaptable.
Evidence and considerations
We've carefully reviewed evidence and conducted thorough consultations to inform the changes we've made.
We've previously consulted on:
- Review of methods, processes and topic selection for health technology evaluation programmes: conclusions and final update.
- Review of methods, processes and topic selection for health technology evaluation programmes: conclusions and final update - Appendix: Discussion and rationale for conclusions – methods (Word).
- Methods proposals second consultation response - NICE task and finish group report (Word).
- Press release: NICE signals commitment to greater flexibility in its evaluation of promising new health technologies and making patient access fairer.
- Press release: NICE publishes new combined methods and processes manual and topic selection manual for its health technology evaluation programmes.
If you have any queries, contact firstname.lastname@example.org.