NICE technology appraisal guidance

Technology appraisals are recommendations on the use of new and existing medicines and treatments within the NHS.

These can be:

  • medicines
  • medical devices
  • diagnostic techniques
  • surgical procedures
  • health promotion activities.

Charges for our technology appraisals came into effect on 1 April 2019. You can view our charging information here.

View technology appraisal guidance

We base our recommendations on a review of clinical and economic evidence.

  • Clinical evidence shows how well the medicine or treatment works.
  • Economic evidence shows how well the medicine or treatment works in relation to how much it costs the NHS - does it represent value for money?

We are asked to look at particular drugs and devices when availability varies across the country. This may be because of different local prescribing or funding policies, or because there is confusion or uncertainty over its value. Our advice ends the uncertainty and helps to standardise access to healthcare across the country.

Technology appraisals take one of 3 forms:

  • A single technology appraisal (STA) which covers a single technology for a single indication.
  • A fast track appraisal (FTA) which also covers a single technology for a single indication but with a shorter process time to speed up access to the most cost-effective new treatments.
  • A multiple technology appraisal (MTA) which normally covers more than one technology, or one technology for more than one indication.

On 3 April 2018 we published an updated technology appraisals process guide which covers the single technology appraisal and fast track appraisal processes, as well as including processes for the Cancer Drugs Fund and assessing budget impact. The process for multiple technology appraisals can be found in the process guide published in September 2014.

Technology appraisals and the NHS Constitution

The NHS is legally obliged to fund and resource medicines and treatments recommended by NICE's technology appraisals.

The NHS Constitution states that patients have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if their doctor believes they are clinically appropriate.

When NICE recommends a treatment 'as an option', the NHS must make sure it is available within 3 months (unless otherwise specified) of its date of publication. This means that, if a patient has a disease or condition and the doctor responsible for their care thinks that the technology is the right treatment, it should be available for use, in line with NICE's recommendations.

Technology appraisal decisions

Each technology appraisal may contain more than one recommendation. We classify our recommendations into 5 categories:

  • recommended
  • optimised
  • only in research
  • not recommended
  • recommended for use in the CDF.

In addition to these types of technology appraisal recommendation, an appraisal committee may make a preliminary recommendation to seek clarification from the manufacturer or sponsor on the key evidence submitted for a technology. This will result in a recommendation which states that ‘the committee is minded not to recommend [the technology]…' and lists the requested information/clarification.

The company is then required to submit the requested clarification/evidence for consideration at the next planned discussion for the appraisal, at which the committee will develop a Final Appraisal Determination setting out its final recommendation(s).

The intention is that the further evidence or analyses could lead to a positive recommendation. However, after consideration of the requested evidence, the committee may decide not to change their preliminary recommendation. If the requested evidence is not provided, the committee will issue a final recommendation which does not recommend the technology, based on the on the original evidence submitted.

Information on the recommendations made by our technology appraisal guidance

Developing technology appraisal guidance

An overview of the development process.

1. Provisional appraisal topics chosen

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

2. Consultees and commentators identified

Consultee organisations include:

  • national groups representing patients and carers
  • bodies representing health professionals
  • the company that manufactures the technology being appraised
  • the Department of Health
  • the Welsh Government
  • NHS England as a specialised commissioning group
  • clinical commissioning groups.

Consultees can make a submission and participate in the consultation on the appraisal consultation document (ACD; if produced). All non-company consultees can nominate clinical experts and/or patient experts to verbally present their personal views to the appraisal committee. Company consultees can also nominate clinical experts. Representatives from NHS England and clinical commissioning groups invited to participate in the appraisal may also attend the appraisal committee as NHS commissioning experts. All consultees have the opportunity to consider an appeal against the final appraisal determination (FAD) and have the opportunity to report any factual errors.

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 ACD (if produced), but NICE does not ask them to make any submission or the appraisal. Non-company commentator organisations can nominate clinical experts and patient experts to verbally present their personal views to the appraisal committee. Commentator organisations representing relevant comparator technology companies can also nominate clinical experts. These organisations receive the FAD and have opportunity to report any factual errors.

3. Scope prepared

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

4. Appraisal topics referred

The Department of Health 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 STA, 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 MTA, NICE invites consultees and commentators to provide a submission
6. Evidence Review Group (ERG) or assessment report prepared

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

  • In an STA, the centre technically reviews the company's evidence submission and prepares an ERG report.
  • In an MTA, the centre reviews published evidence on the technologies and prepares an assessment report. Consultees and commentators are invited to comment on the report.
7. Committee papers prepared

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

  • the ERG or assessment report, and any comments received on it
  • written submissions
  • statements from patient, clinical and commissioning experts.
8. Appraisal 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. Appraisal consultation document (ACD) produced

The appraisal committee makes its provisional recommendations in the ACD. Consultees and commentators have four weeks to comment on the ACD. The ACD is also made available on our website so health professionals and members of the public can comment on it.

An ACD will be produced if the recommendations from the appraisal committee do not recommend use of the technology or limit the use of the technology beyond the specifications in the marketing authorisation. An ACD will also be produced in an STA if the appraisal committee asks NICE to seek clarification from the company on the key evidence submitted for a technology (a 'minded no' recommendation).

10. Final appraisal determination (FAD) produced

The appraisal committee considers the comments received on the ACD (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 FAD.

11. Guidance issued

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

Intervention/comparator technologies

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

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.

Changes to health technology evaluation

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

Past consultations on our ways of working

Consultation on proposed changes to the technology appraisals programme

Consultation on proposed changes to the technology appraisals programme - phase 2

Abbreviated technology appraisal process

Changes to technology appraisals and highly specialised technologies

Interim access agreement with Vertex Pharmaceuticals

Lumacaftor–ivacaftor, tezacaftor and ivacaftor combination therapy are available on the NHS for treating cystic fibrosis homozygous for the F508del mutation.

NHS England has agreed an interim access agreement with Vertex Pharmaceuticals, which includes collecting further data through an interim data collection agreement.

Independent academic centres

We commission independent centres to review the published evidence when developing technology appraisals guidance.

Decision Support Unit and technical support documents

The Decision Support Unit (DSU) is commissioned by NICE to provide a research and training resource to support the technology appraisal programme.

The DSU is a collaboration between the Universities of Sheffield, York and Leicester. We commissioned the DSU to develop a series of technical support documents with the aim of providing further information about how to implement the approaches described in the current guide to the methods for technology appraisals.

The production of these documents was funded by NICE through the DSU. The views, and any errors or omissions, expressed in these documents are of the author(s) only. NICE may take account of part or all of these documents if it considers it appropriate, but it is not bound to do so.

Documents

Technology appraisal process and methods guides

Technology appraisal submission templates

Company submission templates

Company cost comparison submission templates

Other consultee templates

Biosimilar technologies

Early Access to Medicines Scheme (EAMS)

Other documents

EQ-5D-5L: Position Statement (updated October 2019)

Technology appraisals and clinical trials participation

Participation in clinical trials and subsequent access to drugs appraised by NICE - a statement on the applicability of technology appraisal guidance

Patients taking part in clinical trials may receive drugs which have been evaluated by NICE technology appraisal guidance. Queries have been raised regarding the applicability of NICE technology appraisals for patients who have previously received the same medication as part of a clinical trial.

Research is a core function of the NHS. Use of NICE appraised medicines within the clinical trial context should be viewed as use in new and experimental circumstances. It should be noted that in these circumstances the drug is not being prescribed as part of routine clinical practice.

Arrangements for the supply and funding of the technology provided in clinical trials after the trial ends should be agreed with appropriate commissioners before the trial commences. Once the clinical trial ends, the patient will need to discuss with their doctor whether it is clinically appropriate to continue receiving the medication.

For the avoidance of any doubt, if a patient's clinical condition falls within the recommendation of a NICE technology appraisal, they should be prescribed the medication as recommended in the guidance, regardless of any previous participation in a clinical trial in which they may have received medicines for their condition.

On occasion, NICE will make a recommendation that a drug should not be prescribed, but that patients who are currently receiving it as part of their routine clinical care should continue to do so. It is important to note that this recommendation does not cover situations where patients are receiving the medication as part of a clinical trial.