NICE process and methods

2 Selecting 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 NICE's Technology Appraisal 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 and figure 2.

2.1.3 NICE manages this process on behalf of the Department of Health and Social Care. 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 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 about 20 months before marketing authorisation and of new indications about 15 months before marketing authorisation. These time frames are to enable NICE to publish guidance as close as possible to product launch. They may vary depending on whether the topic is a cancer or non-cancer indication. 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.

2.2 Elimination, filtering and prioritisation

2.2.1 Topic selection decisions are based on considering 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:

  • a topic for which there is published NICE guidance

  • a topic for which NICE guidance 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 and Social Care, 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 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 and Social Care 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 – for technologies that are considered suitable for existing national procurement processes.

2.2.3 Topics are not considered unless:

  • 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 for which technology appraisal guidance would not add value without broader guidelines on the clinical pathway.

2.2.4 The importance of each topic is considered against prioritisation criteria that help the Secretary of State for Health and Social Care 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?

2.2.5 Elimination, filtering and prioritisation is done by the consultant clinical adviser in the topic selection team. It includes seeking expert opinion and engaging with the relevant commissioners, clinical reference group chairs or members and national clinical directors when appropriate. The filtering recommendations are considered by an internal group at NICE and by NHS England.

2.2.6 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.

2.2.7 The National Institute for Health Research Innovation Observatory at the University of Newcastle develops technology briefings for potential appraisal topics. The briefings, prioritisation recommendations and draft scopes are considered by a joint decision-making group made up of NICE, the Department of Health and Social Care and NHS England. This group meets (known as decision point 3 [DP3]) 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.

2.2.8 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, for an evidence summary to help inform local decision-making or for the Commissioning Support Programme.

2.2.9 As part of the arrangements for managing the Cancer Drugs Fund from 2016, all new cancer drugs and significant new licensed indications for cancer drugs will be referred automatically to NICE for appraisal. As a result, referral for all cancer drugs is sought early in the selection process and will be received before the draft scope consultation.

2.2.10 Technologies can be routed to the technology appraisal topic selection process from the Medical Technologies Evaluation Programme (MTEP) following consideration at the medical technologies topic oversight group. These technologies go straight to the pre-scoping stage, DP3. For further details on the MTEP programme and its routing options please see the process guide.

2.3 Process

Figure 1 Overview of the topic selection stages for non-cancer topics

Figure 1 Overview of the topic selection stages for non-cancer topics

Figure 2 Overview of the topic selection stages for cancer topics

Figure 2 Overview of the topic selection stages for cancer topics

2.4 Developing the remit and scope

Developing the draft scope

2.4.1 After identifying topics through the topic selection process, 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 3a and figure 3b.

2.4.2 The draft scope sets out what questions the potential appraisal will address. It will steer and focus the appraisal.

2.4.3 The first step in the scoping process is to identify information about the technology. NICE's information specialists work with the technical leads to carry out literature searches, check the availability of relevant evidence, and contact the company. NICE uses this information, along with the technology briefing prepared by the National Institute for Health Research Innovation Observatory, to prepare a draft scope.

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

  • the population, for 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.

2.4.5 For appraisals that are identified as potentially suitable for the fast track appraisal process, consultees and commentators are invited to comment during the scope consultation on whether the technology is suitable for this process.

2.4.6 Unless the Department of Health and Social Care 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

2.4.7 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.

2.4.8 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 the company and specialised commissioning groups; NHS England and 2 clinical commissioning groups. The 2 clinical commissioning groups are selected at random from the clinical commissioning groups operating in the NHS in England.

2.4.9 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.

2.4.10 During the scoping phase, NICE aims to identify the widest possible range 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 or learning disabilities.

2.4.11 Any organisation meeting the criteria in sections 2.4.8 and 2.4.9 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 (up to final appraisal document [FAD] stage).

Consultation on the draft stakeholder list and draft scope

2.4.12 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 the 'stakeholder list'), for comment. The aim of this consultation is to gather views on whether NICE should appraise the technology (non-cancer topics only), as well as ensuring all the relevant areas and issues are covered in the potential appraisal. NICE asks identified provisional consultees and commentators if there are other organisations that need to be included in the consultation. Consultees and commentators have 28 calendar days from the date of sending to submit comments.

2.4.13 NICE asks the company to confirm the expected timing and details of marketing authorisation or CE marking in the UK.

2.4.14 NICE publishes the draft remit, draft scope and list of consultees and commentators on its website, for information, 7 calendar days after it sends these documents to the provisional consultees and commentators.

The scoping workshop

2.4.15 After the provisional consultees and commentators have submitted their comments on the draft remit, draft scope and list of consultees and commentators, NICE may hold a scoping workshop meeting. A scoping workshop may be held if the topic covers a new disease area that the Technology Appraisal Programme has not appraised before, or a workshop for the disease area in question has not been held for a while, or there are uncertainties with the topic that a workshop could address. The workshop can be a face-to-face or a teleconference meeting. NICE invites all provisional consultees and commentators to send up to 2 representatives to this meeting.

2.4.16 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.

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

2.4.18 At the scoping workshop, NICE encourages the company to provide preliminary details of the evidence it would submit if NICE were 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

2.4.19 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 and Social Care.

2.4.20 For non-cancer topics only, NICE submits a report to the Department of Health and Social Care summarising the results of the consultation and scoping workshop discussions (known as the block scoping report). This information helps the Minister to decide whether or not the technology should be formally referred to NICE for appraisal. If the Minister decides to refer a technology, it is formally referred to NICE for appraisal along with the final remit.

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

2.4.22 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.

2.4.23 NICE may need to refine the remit and scope further at the request of the Minister.

Figure 3a Steps in developing the scope (non-cancer topics)

Figure 3a Steps in developing the scope (non-cancer topics)

Figure 3b Steps in developing the scope (cancer topics)

Figure 3b Steps in developing the scope (cancer topics)

Planning the referred appraisals into the work programme

2.4.24 After formal referral, NICE plans the topic into the work programme, and normally publishes the detailed timelines on its website within 6 weeks. NICE will also liaise with the company to confirm the timing of the appraisal. If the company requests a delay, NICE will consider this on a case-by-case basis. If a delay is agreed, NICE works with the company to release as much information as possible to interested parties. Information will also be published on the topic webpage on the NICE website.

2.4.25 Occasionally, timelines may have to change, either before or during the appraisal. NICE will inform consultees and commentators about these changes and, if possible (subject to any confidentiality restrictions), explain the reasons for the changes.

2.4.26 An appraisal is expected to begin before UK regulatory approval for the technology has been granted.

2.4.27 If the timelines of the appraisal are following the anticipated time frame for regulatory approval, the company must notify NICE when it sends a letter of intent to the regulator for the technology being appraised. The notification should also specify when an opinion is expected from the Committee for Medicinal Products for Human Use (or equivalent), when it expects to receive regulatory approval, and the expected wording of the marketing authorisation. The company should also state whether it expects the launch date for its technology in the UK to differ from the regulatory approval date. Companies must inform NICE immediately if there are changes in the regulatory approval process that will affect the time frame or have implications for the wording of the marketing authorisation or CE mark.

2.4.28 For medicinal products, 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 the company receives the marketing authorisation and introduces the technology in the UK. For medical devices and diagnostics, the committee meeting will be planned early enough to allow timely access, subject to NICE guidance.

2.4.29 During the referral process, NICE asks the National Institute for Health Research's Health Technology Assessment Programme to formally commission the evidence review group (ERG) to produce a report.

2.4.30 The process timings described in this guide are in calendar days. Process timings will be extended when they are affected by public holidays.

Selecting technologies for the fast track appraisal process

2.4.31 A technology can be considered for the fast track appraisal process if:

  • The company's base-case incremental cost-effectiveness ratio (ICER) is less than £10,000 per quality-adjusted life year (QALY) gained.

  • It is likely that the most plausible ICER is less than £20,000 per QALY gained, and it is highly unlikely that it is greater than £30,000 per QALY gained.

2.4.32 Judgements about the technology's suitability for the fast track appraisal process, considering the criteria outlined in section 2.4.31, will be based on:

  • the robustness of the clinical-effectiveness evidence and its generalisability to the population under consideration

  • the consistency of the submission with the scope of the appraisal

  • the consistency of approach to modelling with models accepted in previous appraisals in the same, or similar indications

  • the size of the population

  • the budget impact of implementing the technology

  • the uncertainties in the evidence and

  • the consequences of decision error.

2.4.33 Topics will not be appraised through the fast track appraisal process if NICE considers that the uncertainty is too great for a recommendation to be made without the appropriate level of scrutiny required by the committee. For example, if there is a very high degree of uncertainty in the cost-effectiveness estimates then the topic will be appraised through the standard process.

2.4.34 Companies who want their technology to be appraised through the fast track appraisal process are encouraged to get in touch with NICE as early as possible, for example during the scoping stage.

2.4.35 The scheduling of any fast track appraisal will initially follow the timing of a standard appraisal until NICE confirms that the technology is suitable for fast tracking.

2.4.36 The final decision about using the fast track appraisal process is the responsibility of NICE, informed by stakeholder input during scoping. It is based on NICE's review of the evidence supported by an ERG, and is normally made 6 to 8 weeks after the company submission is received.