Highly specialised technology (HST) evaluations are recommendations on the use of new and existing highly specialised medicines and treatments within the NHS in England.

View HST guidance

How we identify topics

We only consider drugs for very rare conditions. The majority 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 HST 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 (DHSC) produces a list of provisional evaluation topics.

  2. Consultees and commentators identified

  3. Scope prepared

    NICE works with the DHSC 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 DHSC refers HST evaluation topics to NICE.

  5. Evidence submitted

    The manufacturer or sponsor of the technology is invited to provide an evidence submission. NICE also invites 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

    NICE commissions 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.

  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 four weeks to comment on the ECD. The ECD 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.

Changes we're making to health technology evaluation

We're reviewing and, where necessary, updating the methods and processes that we use to produce guidance around health technologies.

The consultation on the case for change to the methods is now open until 18 December 2020. Tell us your views.

Charging for evaluations

Charges for our highly specialised technology evaluations came into effect on 1 April 2019  

EQ-5D-5L: NICE Position Statement (updated November 2018)

Our position on use of the EQ‑5D‑5L valuation set for England

Past consultations on our ways of working

Changes to technology appraisals and highly specialised technologies

Useful documents

Get involved

Find out more about the Highly Specialised Technology Evaluation Committee, including how to attend a meeting.