NICE considers topics that support healthcare professionals and others to make sure that the care they provide is of the best possible quality and offers the best value for money.

The topics that we develop guidance on come from a number of sources such as clinical and public health professionals, patients, carers and the general public.

Find out how different teams at NICE select their topics for development into information, advice and guidance.


Technology appraisal topic selection

Our consultation on the processes of technology appraisal highlighted a lack of information on the progress of topics through topic selection.

As a result we have made the reporting of topic progress more open and transparent.

This has been agreed following extensive negotiations with:

  • the Department of Health
  • Association of the British Pharmaceutical Industry (ABPI)
  • the Ethical Medicines Industry Group (EMIG) (as the representative organisations for pharmaceutical companies in the UK).

Decisions from January 2015 onwards are published in this format.

Decisions from July 2011-December 2014 are still available with the original confidentiality agreements in place.

Topic selection technology appraisal decisions

 

How we select topics

Topic selection is the process for deciding which topics NICE will produce technology appraisal guidance on. NICE aims to consider all new significant drugs and indications. Health technologies referred to the NICE technology appraisals programme include:

  • medicinal products
  • medical devices
  • diagnostic techniques
  • surgical procedures or other therapeutic techniques
  • therapeutic technologies other than medicinal products
  • systems of care
  • screening tools

The topic selection process has been designed to support the technology appraisal process so that topics chosen will add value and support healthcare professionals and others to provide care of the best possible quality, which offers the best value for money.

NICE manages this process on behalf of the Department of Health. NICE can only begin to appraise a technology when it has been formally referred by the Secretary of State for Health.

The aims of the topic selection process are to:

  • ensure NICE addresses topics of importance to patients, carers, healthcare professionals, commissioners, providers and public health
  • help make the best use of NHS resources
  • coordinate the selection of topics using a standard selection process
  • make topic selection as rapid as possible to minimise the period of uncertainty before guidance is issued
  • ensure that all topic selection activities are inclusive, open, transparent and consistently applied
  • ensure that all stages of the process are well documented with clear operating procedures and responsibilities and that throughout there is clear and visible progress tracking for all topics considered
  • ensure there are appropriate governance structures and arrangements in place with all relevant parties.

Most topics are identified by the National Institute for Health Research Innovation Observatory at the University of Newcastle. This centre notifies NICE about key, new and emerging healthcare technologies that might be suitable for NICE technology appraisal. It aims to notify NICE of new drugs in development 20 months before marketing authorisation and new indications 15 months before marketing authorisation. These time frames are required by NICE to enable guidance to be published as close as possible to product launch.

Suggestions for technology appraisal guidance on a new medicinal product (that has not yet received a marketing authorisation) should be made by the relevant company through UKPharmaScan. Healthcare professionals, researchers and patients can also suggest potential technologies for NICE to appraise by contacting the National Institute for Health Research Innovation Observatory.

Elimination and filtering

Topic selection decisions are based on the consideration of each potential topic against elimination and prioritisation criteria. The elimination criteria filter out topics unsuitable for guidance development through the technology appraisal programme. A topic will not be considered if the technology has not been granted a marketing authorisation (or equivalent) or if there are no plans for it to receive a marketing authorisation (or equivalent) or if it is identical to:

  • NICE guidance that has been published
  • NICE guidance that is in development
  • a topic currently in the topic selection process
  • a topic that has been considered and eliminated from the topic selection process
  • a topic that has been considered in the last 3 years and not been prioritised
  • a topic widely accepted and implemented on the basis of existing published guidance from the Department of Health, Arm’s Length Body or other government departments (excluding national service frameworks, white papers and planning priorities guidance)

The following topic areas are also outside the remit of technology appraisal guidance development at NICE:

  • Population screening – falls under the remit of the UK National Screening Committee.
  • Vaccination – generally falls under the remit of the Joint Committee on Vaccination and Immunisation. However, NICE does consider therapeutic vaccines.
  • HIV technology or therapy – falls under the remit of the British HIV Association. However, there may be situations when the Department of Health considers that a NICE appraisal of an HIV technology or therapy would be helpful to the NHS and these will be dealt with on a case-by-case basis.
  • Haemophilia – covered by national evaluation and procurement processes.

Topics are not considered unless:

  • there is likely to be significant benefit to patients in terms of administration, efficacy or improved side-effect profile and
  • the new formulation or technology is likely to be at a significantly different price to current standard treatment and
  • there is appropriate evidence, either available or anticipated to be available in the near future, to support the appraisal (refer to section 3.3 of the Guide to the methods of technology appraisal) and
  • the relevant clinical question(s) can be addressed by applying the technology appraisal methodology. This may mean excluding topics on which technology appraisal guidance would not add value without broader guidelines on the clinical pathway.

Elimination and filtering is done by the Consultant Clinical Adviser in the topic selection team and includes seeking expert opinion and engaging with the relevant National Clinical Directors. The filtering recommendations are considered by an internal group at NICE, and shared with the Department of Health and NHS England.

Prioritisation

The importance of each topic is considered against prioritisation criteria prioritisation criteria that help the Secretary of State for Health decide which topics should be referred to NICE for guidance development through the technology appraisal programme. This includes consideration of the population size, disease severity, resource impact and the value that NICE could add in carrying out a technology appraisal. The prioritisation criteria are:

  • Is the technology likely to result in a significant health benefit, taken across the NHS as a whole, if given to all patients for whom it is indicated?
  • Is the technology likely to result in a significant impact on other health-related Government policies?
  • Is the technology likely to have a significant impact on NHS resources if given to all patients for whom it is indicated?
  • Is there significant inappropriate variation in the use of the technology across the country?
  • Is NICE likely to be able to add value by issuing national guidance? For example, without such guidance is there likely to be significant controversy over the interpretation or significance of the available evidence on clinical and cost effectiveness?

Prioritisation is also done by the Consultant Clinical Adviser in the topic selection team and is informed by the external expert opinion already sought during filtering. The National Institute for Health Research Innovation Observatory at the University of Newcastle develops technology briefings for potential appraisal topics.

Relevant companies have the opportunity to comment on these technology briefings before the prioritisation recommendations are considered by an internal group at NICE, and shared with the Department of Health and NHS England. The group at NICE meets to decide the next steps for each topic being considered, to ensure the timely production of guidance. The group considers each topic and decides whether it is potentially suitable for NICE appraisal and as a result, whether the scope should be sent out for consultation.

Summary information on topic progress is published on the NICE website. The list of potential topics is handed over to the technology appraisal scoping team to develop the draft scopes for consultation.

Medicinal products marketed in England that do not meet the criteria for referral into the technology appraisal programme can be considered for the highly specialised technologies programme or for a new medicines evidence summary to help inform local decision-making. 

Biosimilars

NICE’s approach on biosimilars is:

a. NICE will consider similar biological medicinal products notified to it by the National Institute for Health Research Innovation Observatory for referral to the Technology Appraisal topic selection process.

b. These products will usually be considered in the context of a Multiple Technology Appraisal in parallel with their reference products in the indication under consideration.

c. In other circumstances, where it is considered a review of the evidence for similar biological medicinal product is necessary, NICE will consider producing an ‘Evidence summary new medicine’.

d. NICE technology appraisals will use the name of the active drug substance, including reference products and brand named similar biological medicinal products in its documentation where appropriate to inform clinical decision making and to reflect the remit received from Ministers.

e. The Department of Health in England has confirmed that a technology appraisal remit referred to NICE enables NICE to decide to apply the same remit, and the resulting guidance, to relevant licensed biosimilar products which subsequently appear on the market.

f. Evidence summaries will use the brand names of the medicines because substitutability and interchangeability cannot be assumed. Evidence summaries do not make recommendations hence the decision regarding the choice of biosimilar or originator biologic for an individual patient rests with the responsible clinician in consultation with the patient.

Companies wanting to suggest new pharmaceutical products

Companies that want to suggest that NICE develops guidance on a new pharmaceutical product (one that is not yet licensed or used within the NHS) should notify UK PharmaScan. More information is on the Pharmascan website. Alternatively, please contact the National Institute for Health Research Innovation Observatory.


Highly specialised technologies topic selection

Decisions on potential highly specialised technologies from January 2015 onwards are now available and replicate the open and transparent reporting of technology appraisal topics that were first published in February 2015. More detail can be found in the technology appraisal section above. Please note that decisions from July 2013 – July 2014 are still available with the original confidentiality agreements in place.

 
 

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 Innovation Observatory at the University of Newcastle. 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

How topics are selected

The Secretary of State for Health formally refers highly specialised technologies to NICE for evaluation. These decisions are based on the consideration of each topic against our elimination criteria. The elimination criteria remove any unsuitable topics from potential consideration for guidance development through the highly specialised technologies programme. A topic will not be considered if there are no plans to licence the drug in the UK.

Information on any potential highly specialised technology appraisal topics will be available in the coming months. Please note published information is subject to the confidentiality agreement with the relevant companies and therefore full information may not be published.

The following are also out of remit:

  • Population screening - falls under the remit of the UK National Screening Committee.
  • Vaccination - falls under the remit of the Joint Committee on Vaccination and Immunisation (JCVI). NICE will consider therapeutic vaccines.
  • HIV technology/therapy - falls under the remit of the British HIV Association. However, there may be situations where the Department of Health considers that a NICE appraisal of a HIV technology or therapy would be helpful to the NHS and these will be dealt with on a case by case basis. The Centre for Public Health Excellence at NICE have in the past, and will continue to, consider HIV-related issues for its work programme.
  • Haemophilia – covered by national evaluation and procurement processes

Topics are not considered unless:

  • there is likely to be significant benefit to patients in terms of administration, efficacy or improved side effect profile
  • the new formulation or technology is at, or likely to be at a significantly different price
  • there is appropriate evidence, such as would enable evaluation, either available or anticipated to be available in the near future
  • the timing is right. NICE is committed to publishing timely guidance within six months of the marketing authorisation
  • the relevant clinical question(s) can be addressed by the application of the highly specialised technologies evaluation methodology? This would exclude topics on which guidance to NHS England would be of inadequate value in the absence of broader guidelines on the clinical pathway within which the technology should be contextualised

The importance of each topic is considered against the prioritisation criteria that help the Secretary of State decide which topics should be referred to NICE for guidance development through the highly specialised technologies programme. The aim is always to add value. For a topic to be selected, all criteria need to be met. The prioritisation criteria are:

  • The target patient group for the technology in its licensed indication is so small that treatment will usually be concentrated in very few centres in the NHS;
  • The target patient group is distinct for clinical reasons;
  • The condition is chronic and severely disabling;
  • The technology is expected to be used exclusively in the context of a highly specialised service;
  • The technology is likely to have a very high acquisition cost;
  • The technology has the potential for life long use;
  • The need for national commissioning of the technology is significant.

Companies wanting to suggest new pharmaceutical products

Companies that want to suggest that NICE develops guidance on a new pharmaceutical product (one that is not yet licensed or used within the NHS) should notify UK PharmaScan. More information is on the Pharmascan website. Alternatively, please contact the National Institute for Health Research Innovation Observatory.


Public health topic selection

NICE considers suggested topics at quarterly internal topic selection group meetings to assess whether they meet NICE's remit.

 
  • Topics are suggested. These can be broad topic areas, or specific suggestions. It is important that topics are relevant and timely, and that they address priority issues that will help to improve the health of the population. The topic selection process also ensures that the selection of public health and clinical guidance topics is coordinated.
  • NICE considers suggested topics at quarterly internal topic selection group meetings to assess whether they meet NICE's remit.
  • NICE produces a background briefing paper for those topics that meet the remit (see section 2.2 of Methods for the development of NICE public health guidance - third edition (2012).
  • NICE convenes a topic advisory workshop (TAW) of experts and stakeholders, including Public Health England and the Department of Health, where the briefing paper and areas for draft referrals are agreed (see section 2.2.4 of Methods for the development of NICE public health guidance - third edition (2012).
  • NICE conducts an internal check to ensure a good fit between proposed public health topics and any related clinical topics.
  • Draft referrals are discussed with policy leads at the Department of Health, who then prepare a submission to ministers for formal consideration.
  • Once ministers have considered the submission, 1 or more formal ministerial referrals may be made to NICE to develop public health guidance in the topic area.
  • Final responsibility for public health guidance referrals remains with the Secretary of State for Health
  • Referral is then added to NICE website.

Medicines evidence summaries topic selection

Information on how we select topics for evidence summaries can be found in the process guide:

Evidence summaries: process guide


Clinical guidelines topic selection

The Department of Health refers clinical guideline topics to NICE.

 Read more about clinical guidelines


Medical technologies topic selection

The NICE medical technologies evaluation programme (MTEP) selects and evaluates new or innovative medical technologies (including devices and diagnostics). MTEP helps the NHS adopt efficient and cost effective medical devices and diagnostics more rapidly and consistently.

Whilst it is normally clinicians that notify medical technologies to NICE, anyone can request NICE consider a medical technology for guidance by completing our notification form.

 Read more about MTEP topic selection


Quality standards topic selection

Topics are referred to NICE by NHS England for health-related areas, and by the Department of Health and Department for Education for non-health areas such as social care.

Read more about quality standard topic selection