Overview: how we develop technology appraisal guidance

1. Provisional appraisal topics chosen

The NICE topic selection programme produces a list of provisional appraisal topics.

2. Stakeholders identified

Technology appraisal stakeholders can be either consultees or commentators.

Consultee organisations include:

• national groups representing patients and carers
• bodies representing healthcare professionals
• the company that manufactures the technology being evaluated
• the Department of Health and Social Care
• the Welsh Government
• NHS England
• integrated care boards.

Consultees

Consultees can make a submission and participate in the consultation on the draft guidance (if produced).

All non-company consultees can nominate either clinical experts, or patient experts, or both, to verbally present their personal views to the evaluation committee. Company consultees can also nominate clinical experts. Representatives from NHS England and clinical commissioning groups invited to participate in the evaluation may also attend the evaluation committee as NHS commissioning experts.

All consultees have the opportunity to consider an appeal against the final draft guidance and have the opportunity to report any factual errors.

Commentators

Commentator organisations include but are not restricted to:

• relevant comparator technology companies
• Healthcare Improvement Scotland
• any relevant national collaborating centres, research groups working in the area and others.

Commentators can participate in the consultation of the draft guidance (if produced), but NICE does not ask them to make any submission for the appraisal.

Non-company commentator organisations can nominate clinical experts and patient experts to verbally present their personal views to the evaluation committee. Commentator organisations representing relevant comparator technology companies can also nominate clinical experts. These organisations receive the final draft guidance and have opportunity to report any factual errors.

3. Scope prepared

NICE develops a scope. The scope defines the condition, the patients and the technologies covered by the appraisal and the questions it aims to answer. Stakeholders are requested to comment on the draft scope.

Intervention and comparator technologies

The technology being evaluated is listed in the scope of a technology appraisal under 'intervention'. We can only make recommendations about the intervention being evaluated.

A comparator technology is one that is currently used in the NHS and could be replaced by the intervention, if recommended. We cannot issue guidance or make recommendations about comparator technologies, unless also listed as an intervention in a multiple technology appraisal.

4. Appraisal topics referred

The Department of Health and Social Care refers technology appraisal topics to NICE.

5. Evidence submitted

An evidence submission is a concise, comprehensive and structured report of all relevant information (published and unpublished) for an appraisal.

• In an single technology appraisal, the company is invited to provide an evidence submission. All non-company consultees are also invited to submit a statement on the potential clinical and cost effectiveness of a technology.
• In an multiple technology appraisal, NICE invites stakeholders to provide a submission.

6. External assessment group or assessment report prepared

An independent academic centre is commissioned by NICE to prepare a report.

• In an single technology appraisal, the centre technically reviews the company's evidence submission and prepares an external assessment group report.
• In an multiple technology appraisal, the centre reviews published evidence on the technologies and prepares an assessment report. Stakeholders are invited to comment on the report.

Our independent academic centres

• BMJ Technology Assessment Group (BMJ-TAG), BMJ
• Centre for Reviews and Dissemination and Centre for Health Economics, University of York
• Health Economics Research Unit and Health Services Research Unit, University of Aberdeen
• Kleijnen Systematic Reviews Ltd
• Liverpool Reviews and Implementation Group, University of Liverpool
• Peninsula Technology Assessment Group (PenTAG), University of Exeter
• School of Health and Related Research (ScHARR), University of Sheffield
• Southampton Health Technology Assessment Centre (SHTAC), University of Southampton
• Warwick Evidence, Warwick Medical School, University of Warwick

7. Committee papers prepared

These include all of the evidence that will be looked at by the evaluation committee. This evidence includes:

• the external assessment group or assessment report, and any comments received on it
• written submissions
• statements from patient, clinical and NHS commissioning experts.

8. Evaluation committee

An independent advisory committee considers the report created in step 6 and hears evidence from nominated clinical, patient and NHS commissioning experts. The committee discussions are held in public.

9. Draft guidance produced

The evaluation committee makes its provisional recommendations in the draft guidance. Stakeholders have 4 weeks to comment on the draft guidance. The draft guidance is also made available on our website so healthcare professionals and members of the public can comment on it.

Draft guidance will be produced if the recommendations from the evaluation committee do not recommend use of the technology or limit the use of the technology beyond the specifications in the marketing authorisation.

Following consultation on the draft guidance a second committee meeting is held, this usually occurs 2 months after the first committee meeting.

10. Final draft guidance produced

The evaluation committee considers the comments received on the draft guidance (if produced), then makes its final recommendations on how the technology should be used in the NHS in England. Consultees can appeal against the final recommendations in the final draft guidance.

11. Guidance issued

If there are no appeals, or an appeal is not upheld, the final recommendations are issued as NICE guidance.