Highly specialised technology (HST) evaluations are recommendations on the use of new and existing highly specialised medicines and treatments within the NHS in England. The highly specialised technologies programme only considers drugs for very rare conditions. The vast majority of our topics are identified by the National Institute for Health Research Horizon Scanning Centre at the University of Birmingham. They aim to notify the Department of Health 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.

An overview of the development process:

  1. Provisional evaluation topics chosen

    The Department of Health (DH) produces a list of provisional evaluation topics.

  2. Consultees and commentators identified

  3. Scope prepared

    NICE works with the DH 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 DH 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) if produced

    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.