2 Selection of technologies

2.1 Overview

2.1.1 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.

2.1.2 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. The steps involved are shown in figure 1.

2.1.3 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.

2.1.4 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.

2.1.5 Most topics are identified by the National Institute for Health Research Innovation Observatory (NIHRIO). 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 NIHRIO.

2.2 Elimination and filtering

2.2.1 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).

2.2.2 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.

2.2.3 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.

2.2.4 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.

2.3 Prioritisation

2.3.1 The importance of each topic is considered against 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?

2.3.2 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. NIHRIO 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.

2.3.3 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.

2.3.4 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.

2.4 Process

Figure 1 Overview of the topic selection stages

2.5 Developing the remit and scope

Developing the draft scope

2.5.1 After identifying topics through the topic selection programme, NICE seeks the views of interested parties. At this stage, NICE develops a draft remit and draft scope for each potential appraisal. The steps involved are shown in figure 2.

2.5.2 The draft scope sets out what questions the appraisal will address. It will steer and focus the appraisal if the technology is formally referred to NICE for appraisal.

2.5.3 The first step in the scoping process is to identify information about the technology. NICE's information specialists, working with the appraisal team's technical leads, do this task, which includes literature searching, checking the availability of relevant evidence, and contacting the company. NICE uses this information, along with the technology briefing prepared by the National Institute for Health Research Horizon Scanning Centre, to prepare a draft scope.

2.5.4 The draft scope defines a number of elements, including:

  • the population, in whom treatment with, or use of, the technology would be appraised

  • the potential comparators

  • the potential subgroups

  • the health outcome measures

  • any other special considerations and issues that are likely to affect the potential appraisal, including equality and diversity issues.

    For further information on how scopes are developed, see NICE's Guide to the methods of technology appraisal.

2.5.5 Unless the Department of Health specifically indicates otherwise, NICE will not publish guidance on the use of a technology for indications that have not been given regulatory approval in the UK (that is, for unlicensed or 'off-label' use outside the terms of the technology's marketing authorisation).

Identifying interested parties

2.5.6 Identifying interested parties (known as consultees and commentators; see table 1) is an important stage of the process. NICE identifies consultees and commentators before it consults on the draft remit and draft scope.

2.5.7 A patient or professional group can be a consultee if it works at a national level (covering the UK or England, or a UK branch of an international body) and represents patients, carers or healthcare professionals either broadly or directly related to the technology being considered. Other consultees include specialised commissioning groups – NHS England and 2 clinical commissioning groups (CCGs) and the company. The 2 CCGs are selected at random from the pool of CCGs operating in the NHS in England.

2.5.8 Commentators include research organisations with an interest in the technology being considered, organisations that cover the NHS as a whole, such as the NHS Confederation, patient and professional organisations covering Northern Ireland or Scotland or Wales only, and relevant comparator and companion diagnostic test companies. Other organisations may be included as commentators when appropriate.

2.5.9 During the scoping phase, NICE aims to identify the widest range possible of relevant consultees and commentators who have an interest in the technology or disease area being considered. This includes, but is not restricted to, national organisations representing relevant specific ethnic groups, people with disabilities, mental health problems and/or learning disabilities.

2.5.10 Any organisation meeting the criteria outlined in sections 2.5.7–2.5.9 that wishes to become a consultee or commentator for a proposed appraisal can contact the relevant project manager (see the NICE website for details). A request to join the appraisal as a consultee or commentator can be made at any point during the scoping and appraisal phases of the process.

Consultation on the draft remit and draft scope

2.5.11 NICE sends the draft remit and draft scope to the identified provisional consultees and commentators, together with the list of consultees and commentators (known as a 'matrix'), for comment. The aim of this consultation is to gather views on whether NICE should appraise the technology, as well as ensuring all the relevant areas and issues are covered if the technology is referred to NICE for appraisal. It is important that all the relevant organisations and interested parties are included in these consultations. NICE therefore asks identified provisional consultees and commentators if there are other organisations that need to be included in the consultation. Consultees and commentators have 20 working days from the date of sending to submit comments.

2.5.12 NICE asks the company to provide information about the expected timing of pending marketing authorisation applications (or equivalent) for their technology in the UK. This must include, if applicable, the date on which the Committee for Medicinal Products for Human Use of the European Medicines Agency is expected to publish an opinion on the granting of the marketing authorisation for the technology, and the expected date of receipt of the final marketing authorisation from the European Commission or the Medicines and Healthcare Products Regulatory Agency. The company should also state whether they expect the launch date for their technology in the UK to differ from the regulatory approval date. Medical devices go through a different regulatory approval process to pharmaceuticals with different timelines and data requirements. It is important that the company informs NICE of any change in the regulatory approval timelines as soon as possible. NICE uses this information to plan the appraisal.

2.5.13 NICE publishes the draft remit, draft scope and list of consultees and commentators on its website, for information, 5 working days after it sends these documents to the provisional consultees and commentators.

The scoping workshop

2.5.14 After the provisional consultees and commentators have submitted their comments on the draft remit, draft scope and list of consultees and commentators, NICE normally holds a meeting called the scoping workshop. NICE invites all provisional consultees and commentators, and the Assessment Group (for MTAs only), to send up to 2 representatives to this meeting.

2.5.15 The aims of the workshop are to:

  • briefly explain the appraisal process

  • ensure the scope is appropriately defined

  • discuss the issues raised by provisional consultees and commentators during consultation on the draft remit and draft scope

  • discuss the appropriateness of completing an appraisal and the appropriate appraisal process

  • identify important evidence and any other issues relevant to the potential appraisal.

2.5.16 It is important that sufficient expertise is fed into the development of the scope. NICE welcomes and values all specialist input from patient groups, NHS commissioners and healthcare professionals provided at consultation and during the workshop discussions.

2.5.17 At the scoping workshop, NICE encourages the company to provide preliminary details of the evidence it would submit if NICE were asked to appraise the technology. This may include details of trials in progress, for example the inclusion and exclusion criteria used. At the end of the workshop, the company can discuss commercially sensitive information and technical issues about the proposed appraisal with NICE, in confidence.

Final scope

2.5.18 NICE updates the scope, taking into account comments received during the draft remit and draft scope consultation, and the discussions at the scoping workshop. This is in anticipation of receiving a formal referral to appraise the technology from the Secretary of State for Health.

2.5.19 NICE submits a report to the Department of Health summarising the results of the consultation and scoping workshop discussions (known as the block scoping report). This information helps ministers to decide whether or not the technology should be formally referred to NICE for appraisal and whether it should be referred as an MTA or an STA. If ministers decide to refer a technology, it is formally referred to NICE for appraisal along with the final remit.

2.5.20 NICE publishes the block scoping report (with any commercial in confidence information redacted) on its website after formal referral.

2.5.21 If there is a significant length of time between scoping and the start of the appraisal, NICE may need to update the scope to ensure it is still relevant. Depending on the extent of this update, NICE may carry out further consultation with consultees and commentators. An additional scoping workshop is not routinely held.

2.5.22 NICE may need to refine the remit and scope further at the request of ministers.

Figure 2 Steps in developing the scope

Figure 2 Steps in developing the scope

Planning the referred appraisals into the work programme

2.5.23 After formal referral, NICE plans the topic into the work programme, and normally publishes the detailed timelines on its website within 6 weeks. Occasionally, timelines have to change, either before or during the appraisal. NICE will inform consultees and commentators about these changes and, if possible, explain the reasons for the changes. NICE works with the company to release as much information as possible to interested parties.

2.5.24 An appraisal may begin before UK regulatory approval for the technology has been granted.

2.5.25 For an STA, NICE aims to hold the first Appraisal Committee meeting as soon as possible after the technology gains a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency, or equivalent from the Medicines and Healthcare Products Regulatory Agency. It is therefore essential that the company informs NICE of all developments in the regulatory approval process. This ensures that NICE publishes guidance on the use of the new technology as soon as possible after receipt of the marketing authorisation and/or its introduction into the UK.

2.5.26 During the referral process of an appraisal, NICE asks the National Institute for Health Research – Health Technology Assessment programme (NIHR HTA programme) to formally commission the ERG or AG to produce a report.