Highly specialised technologies guidance

We only consider drugs for very rare conditions. Most of our topics are identified by the National Institute for Health Research Innovation Observatory. They aim to notify the Department of Health and Social Care of key, new and emerging healthcare technologies that might need to be referred to NICE against the following timeframes:

• New drugs, in development, at 20 months to marketing authorisation.
• New indications, at 15 months to marketing authorisation.

A single highly specialised technology evaluation can only cover a single technology for a single indication.

Development process

1. Provisional evaluation topics chosen

   The Department of Health and Social Care produces a list of provisional evaluation topics.

2. Consultees and commentators identified

3. Scope prepared

   We work with the Department of Health and Social Care to develop a scope. The scope defines the disease, the patients and the technology covered by the evaluation and the questions it aims to answer. Consultees and commentators are requested to comment on the draft scope.

4. Evaluation topics referred

   The Department of Health and Social Care refers highly specialised technology evaluation topics to NICE.

5. Evidence submitted

   The manufacturer or sponsor of the technology is invited to provide an evidence submission. We also invite all non-manufacturer consultees to submit a statement on the potential clinical effectiveness and value for money of a treatment.

6. Evidence Review Group (ERG) report prepared

   We commission an independent academic centre to technically review the evidence submission and prepare an ERG report.

7. Evaluation report prepared

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

   • the ERG report and any comments received on it
   • written submissions
   • personal statements from patient experts and clinical specialists.

8. Evaluation committee

   An independent advisory committee considers the evaluation report and hears evidence from nominated clinical experts, patients and carers. Evaluation committee discussions are held in public.

   Find out more about the evaluation committee, including how to attend a meeting.

9. Evaluation consultation document (ECD) produced if needed

   The evaluation committee makes its provisional recommendations in the ECD. An ECD will be produced only if the recommendations from the evaluation committee are restrictive. A restrictive recommendation will be one that is more limited than the instructions for use that accompany the technology.

   Consultees and commentators have 4 weeks to comment on the ECD. It is also made available on our website so health professionals and members of the public can comment on it.

10. Final evaluation determination (FED) produced

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

11. Guidance issued

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