Process and methods
8 Linking clinical guidelines to other NICE guidance
As the amount of NICE guidance increases, there will be more topics that span the different work programmes at NICE.
Clinical guidelines focus on the management of a particular disease or condition.
Technology appraisal guidance focuses on the clinical and cost effectiveness of one or more technologies, such as new drugs, surgical procedures and medical devices.
Interventional procedures (IP) guidance covers the safety and efficacy of interventional procedures used for diagnosis or treatment.
Public health guidance deals with promoting good health and preventing ill health.
Medical technologies guidance covers the efficacy and cost effectiveness of new or innovative medical technologies.
Diagnostics guidance covers the efficacy and cost effectiveness of new diagnostic technologies.
NICE has been asked to develop social care guidance, but at the time this manual was updated, the specific details of this programme were not known. Therefore details about links to social care guidance are not provided here.
The Centre for Health Technology Evaluation (CHTE) at NICE develops technology appraisal, interventional procedures, medical technologies and diagnostics guidance. Public health guidance is the responsibility of the Centre for Public Health Excellence (CPHE). Details of the development processes and methods for other programmes can be found on the NICE website.
The scoping stage of clinical guideline development should identify topics from other programmes that are relevant to the guideline being developed (see chapter 2).
This chapter deals with the approaches to be taken when:
guidance from another programme has already been published and requires incorporation into a clinical guideline
NICE asks a Guideline Development Group (GDG) to update an existing piece of guidance in a clinical guideline
a relevant piece of guidance from another programme is being developed concurrently.
NICE publishes two types of technology appraisals:
The single technology appraisal (STA) process is designed specifically for the rapid appraisal of a single technology with a single indication. Most of the relevant evidence for an STA is supplied by the manufacturer or sponsor of the technology. NICE commissions an independent academic centre to technically review the evidence submission and prepare an Evidence Review Group (ERG) report.
The multiple technology appraisal (MTA) process considers the clinical and cost effectiveness of one or more technologies. Evidence for an MTA is derived from a number of sources, including an assessment carried out by an independent academic or other research group (the Assessment Group), evidence provided by the consultees to the appraisal process (including manufacturers), and the participation of selected clinical specialists and patient experts.
Process guides for technology appraisals are available on the NICE website.
A first assessment of a significant new medicine or a significant licence extension for an existing medicine is usually carried out as a technology appraisal. It can be carried out in a clinical guideline only when this has been agreed by both the Department of Health and the manufacturer. If a significant new medicine is identified during the scoping of a guideline, the National Collaborating Centre (NCC) or NICE Internal Clinical Guidelines Programme should alert the Guidelines Commissioning Manager (GCM), who will liaise with the relevant work programmes within NICE.
When the topic of a newly commissioned clinical guideline covers an area for which there are one or more previously published technology appraisals, there are four possible approaches:
The technology appraisal guidance is incorporated verbatim into the clinical guideline.
The clinical guideline cross-refers to the technology appraisal guidance.
The technology appraisal guidance is updated through the relevant technology appraisal process.
The technology appraisal guidance is updated through the clinical guideline development process (see section 8.1.3).
When technology appraisal guidance is incorporated into a clinical guideline, the technology appraisal guidance remains in existence alongside the guideline. The funding direction (which states that the NHS provides funding and resources for drugs and treatments that have been recommended by NICE technology appraisals, normally within 3 months from the date that NICE publishes the guidance) remains in place for the recommendations in the technology appraisal guidance.
Before a decision to incorporate or update a technology appraisal is made, the appraisals team needs to prepare a technology appraisal review proposal. There are two reasons for this:
new evidence may indicate that the appraisal should be updated as a technology appraisal rather than within a clinical guideline (see also section 8.1.3) or
if technology appraisal guidance is incorporated into a clinical guideline, the technology appraisal will usually be placed on the static list (see the technology appraisal process guides).
Developing a review proposal involves consulting with the relevant stakeholders for the technology appraisal. It is essential that relevant technology appraisals that are considered suitable for incorporation into a clinical guideline are identified as early as possible in guideline development, preferably in the early stages of scoping (see chapter 2).
When recommendations from a published technology appraisal are incorporated into a clinical guideline, they should usually be reproduced unchanged. Under exceptional circumstances where suggested changes to recommendation wording are proposed (for example, if the appraisal recommendation covers both primary and secondary care, but the guideline recommendation is concerned with secondary care only), the proposed change to the wording must be discussed with the NICE appraisals team and agreed by NICE's Guidance Executive. This should be done on a case-by-case basis.
126.96.36.199 Guideline question covering a different population or drug indication compared with published technology appraisal guidance
Sometimes a clinical guideline may address a question that relates to a drug for which there is technology appraisal guidance, but covers different population groups or drug indications. In these cases the GDG should apply methodologies comparable with those used in the technology appraisal for assessing the evidence of clinical and cost effectiveness. The final recommendations in the guideline for these groups or indications may be different from the technology appraisal recommendations if there is evidence of differing safety, clinical effectiveness or cost effectiveness for those populations or drug indications.
Planning the update of a technology appraisal is described in the technology appraisal process guides. The NCC becomes a commentator for the appraisal review proposal, which allows it to have formal input into the process of updating the appraisal.
It is anticipated that technology appraisal guidance will only rarely be updated in a clinical guideline. A technology appraisal is likely to be suitable for updating in the context of a clinical guideline only if all of the following conditions are met (see NICE's policy on updating technology appraisals in clinical guidelines).
The technology falls within the scope of the guideline.
There is no proposed change to an existing patient access scheme or flexible pricing arrangement for the technology, or no new proposal(s) for such a scheme or arrangement.
There is no new evidence that is likely to lead to significant changes in the clinical or cost effectiveness of a technology.
The technology is well established and embedded in the NHS. Evidence that a technology is not well established or embedded may include the following:
spending on the technology for the indication that was the subject of the appraisal continues to rise
there is evidence of unjustified variation across the country in access to the technology
there is plausible and verifiable information to suggest that the availability of the technology is likely to be reduced if the funding direction were removed
the technology is excluded from the payment by results (PbR) tariff.
Stakeholder opinion, expressed in response to consultation on a review proposal for the technology appraisal, is broadly supportive of the proposal.
The final decision on whether an existing technology appraisal is to be updated in a clinical guideline will be taken by NICE's Guidance Executive, before the workplan for the guideline is signed off.
When technology appraisal guidance is updated and changed in a clinical guideline, the original appraisal will be withdrawn when the guideline is published. The funding direction associated with the technology appraisal will no longer apply. Similarly, any existing patient access scheme that was agreed as part of the technology appraisal for the particular indication will no longer apply (unless there is a commitment by the manufacturer to continue the scheme).
Early planning is essential to identify how the NCC will undertake any updates of technology appraisals within a clinical guideline. The steps that should be taken are described below.
When planning the clinical guideline, the NCC should consider whether any data exist that are not in the public domain but are likely to be of use in updating the technology appraisal. If so, the NCC should issue a call for evidence from stakeholders, using the procedures described in section 5.10.
If there is significant new clinical evidence or a change in costs since the original technology appraisal guidance was published, the NCC will need to conduct an economic evaluation to determine whether a change in the guidance is appropriate. In exceptional circumstances, it may not be apparent that an economic analysis is necessary until the clinical evidence has been reviewed and discussed by the GDG. Nevertheless, the NCC health economist should start planning for this work at an early stage. The intended approach to cost-effectiveness analysis for technology appraisal updates should be included in the economic plan and discussed with the GDG and NICE (see section 7.1).
Assessments of cost effectiveness for updates of technology appraisals in clinical guidelines should follow the principles described in section 7.2. The approach should be similar to that used in the original technology appraisal (as described in the 'Evidence and interpretation' section of the appraisal guidance document for MTAs or the 'Manufacturer's submission' section for STAs). Any differences in approach must be justified on the basis of changes in the evidence base or the decision context (such as a broader range of comparators in the guideline).
The NCC may sometimes consider that an assessment of cost effectiveness can best be done by updating an existing model (for example, the model provided by the Assessment Group for the original technology appraisal or a model submitted by a manufacturer or sponsor). If so, this should be discussed with the Centre for Clinical Practice (CCP) at NICE during development of the economic plan.
When a technology appraisal is being developed at the same time as a related clinical guideline, there are three important aspects to consider, in order to ensure that the final recommendations in the guideline and the appraisal are complementary and consistent:
exchange of information
publication of recommendations.
The development of related clinical guidelines and technology appraisals will normally be coordinated so that the published appraisal recommendations can be incorporated into the consultation draft of the guideline. Details of the timelines should be agreed between the NCC and the guidelines and appraisals teams at NICE.
Information exchange is mutually beneficial to the Appraisal Committee (which is responsible for formulating technology appraisal guidance) and the GDG, and the GDG needs to be aware of progress in related appraisal topics. The following mechanisms have therefore been put in place.
A member of the NICE appraisals team will be invited to an early GDG meeting to outline the relevant technology appraisal process (MTA or STA). Differences between the appraisal and clinical guideline development processes, the opportunities for input from the GDG to the appraisal process and the status of the ongoing relevant appraisals will be discussed.
A member of the NICE appraisals team will advise the GDG on the integration of the appraisal into the guideline, and will be invited to attend GDG meetings as appropriate.
The GDG will act as a commentator for the relevant appraisal (see technology appraisal process guides).
The GDG Chair (or a delegate) and the NCC Director (or a delegate) will act as links with the technical lead for the appraisal. They will attend the Appraisal Committee meetings when relevant. GDG members attending NICE Appraisal Committee meetings should update their declaration of interests before each meeting. NICE will conduct a review of declarations of interests before selecting GDG representatives to attend Appraisal Committee meetings. Guidance for GDG members on attendance at NICE Appraisal Committee meetings is provided in appendix A4.
For MTAs, the NCC health economist for the clinical guideline and the Assessment Group for the technology appraisal should work together to ensure that the economic models for the guideline and the appraisal are consistent.
For STAs, the health economist for the clinical guideline should familiarise themselves with the manufacturer's model and the critique of the model in the Evidence Review Group report.
The GDG must not publish its own recommendations in a clinical guideline in areas already covered in the scope of any relevant ongoing technology appraisal. This also applies to areas covered in existing published technology appraisals unless NICE has agreed that the technology appraisal guidance will be updated in the clinical guideline (see section 8.1.3).
If technology appraisal recommendations have not been finalised at the time of guideline consultation, the guideline should cross-refer to the appraisal consultation document.
IP guidance differs from other NICE guidance in that it addresses the safety and efficacy of interventions, not their clinical and cost effectiveness. (For more details see the Interventional procedures programme process guide.)
Any published IP guidance that is relevant to the guideline should be identified during the scoping phase of a clinical guideline. There are two approaches, depending on whether the recommendation in the IP guidance is for 'normal' or 'special' arrangements for clinical governance, consent and audit or research. As clinical guidelines focus on placing established treatments in the care pathway, they will generally only include IP guidance that recommends 'normal' arrangements.
There are two possible scenarios, depending on whether the IP guidance merits a review question.
Review question not justified
If the scoping group for a guideline decides that IP guidance for which 'normal' arrangements are recommended is relevant to its clinical guideline but will not justify a review question, the IP guidance will simply be referred to in the 'Related NICE guidance' section of the guideline. The NCC will not search for new evidence on procedures that are not incorporated into a review question. However, if in the course of their search for evidence the NCC finds new relevant evidence on that procedure, they will inform the IP Programme at NICE.
Review question justified
If the scoping group for a guideline considers that a procedure published under 'normal' arrangements for IP guidance is likely to justify a review question, this will be highlighted in the draft scope for the guideline. During consultation on the scope, the IP programme will consult its specialist advisers for the procedure to ascertain whether it is emerging as standard NHS practice. CCP and the IP programme will then draft a joint paper for NICE Guidance Executive describing the intention to address the clinical and cost effectiveness of the intervention in the guideline, the justification for this decision and what is currently known about the availability of new evidence. At this stage any indications within the IP guidance that are outside the scope of the guideline will also be highlighted to Guidance Executive.
Assuming that the intervention is included in the final scope, the NCC will consider the clinical and cost effectiveness of the procedure using the usual methods for clinical guidelines (see chapters 6 and 7).
When the GDG has had the opportunity to review the evidence and consider its recommendation(s), CCP and the IP programme will inform Guidance Executive of the implications of the draft guideline recommendations for the IP guidance.
Normally the IP guidance will remain active. This is because the IP guidance relates to the efficacy and safety of the procedure, and so the clinical guideline and the IP guidance address different questions. Thus IP guidance remains current even if recommendations on efficacy and safety are supplemented by a clinical guideline recommendation on the clinical and cost effectiveness of a procedure for one or some indications. IP guidance may also contain more detailed information about the procedure that may be of value to patients and clinicians. Importantly, the IP guidance may also specify conditions for use of the procedure; for example that the surgeon should have training, or that the procedure should be carried out within the context of a multidisciplinary team. The clinical guideline will include a cross-reference to the IP guidance, and a note referring to the clinical guideline will be inserted on the NICE webpage for the IP guidance.
In circumstances when there is considerable uncertainty about the clinical or cost effectiveness of a procedure, the GDG may decide to make an 'only in research' recommendation relating to the generation of additional evidence on relative clinical or cost effectiveness of the procedure (see section 9.2). The decision to make this type of recommendation for a procedure where IP guidance has been published under 'normal' arrangements will be taken by the GDG in consultation with NICE. This decision will be made on a case-by-case basis, and will require the CCP and IP teams to present an agreed paper to NICE Guidance Executive.
If, in the opinion of the GDG, a procedure with recommendations for 'special' arrangements has become part of mainstream practice and falls into the subject area of a review question, the GDG will formally notify the procedure to the IP Programme to allow for potential review of the IP guidance. If on re-assessment the procedure's status is changed to 'normal' arrangements, the NCC will consider its clinical and cost effectiveness (see section 188.8.131.52). If the procedure retains its 'special' arrangements status (because of concerns about its safety, or because the long-term efficacy is unknown and important), the IP guidance should be listed in the 'Related NICE guidance' section of the clinical guideline.
Sometimes IP guidance will recommend that a procedure should only be carried out in research, or that it should not be used. These recommendations are made if the IP Advisory Committee considers the evidence to be either insufficient or indicative that the intervention is unsafe and/or not effective, and so it is unable to recommend even conditional use. A recommendation not to use a procedure will be made if there is no evidence of efficacy and/or safety, or evidence of a lack of efficacy and/or safety. A 'research only' recommendation will be made if the evidence on the procedure shows that there are important uncertainties. The evidence base for such procedures usually reflects the fact that they are not established procedures. As such, they would not normally form part of a review question in a clinical guideline.
The NCC will check the IP guidance publication list for both published and 'in development' guidance during the guideline development phase. If a clinical guideline is already in development when a relevant notification is received, the IP Programme will pass the finalised scope(s) for the relevant procedure(s) to the CCP at NICE. This will allow appropriate planning and cross-referencing between the two programmes.
If IP guidance in development has not been finalised at the time of the guideline consultation, the IP consultation document is listed in the 'Related NICE guidance' section of the guideline.
When a newly notified procedure has been scoped and it has been agreed that it will be assessed by the IP Programme, and a clinical guideline is already being developed in this area, the IP Programme team will inform the NCC and the NICE GCM that the notified procedure is relevant to the guideline, but the procedure will not form part of the clinical guideline.
NICE public health guidance aims to reduce the risk of developing a disease or condition, and to promote a healthy lifestyle.
Where NICE has published a clinical guideline or public health guidance and a new piece of work is commissioned in a related area, careful thought needs to be given to avoiding unnecessary duplication. The detailed processes for doing this are covered in the update to The NICE public health guidance development process (third edition September 2012).
The Department of Health or the NHS Commissioning Board may ask NICE to develop new combined guidance on both the prevention and clinical management of a condition. A referral for combined guidance is managed jointly by the CCP and the Centre for Public Health Excellence (CPHE). Examples include the prevention and management of obesity, and the prevention, early identification and management of alcohol use disorders in adults and adolescents.
Two separate groups or committees at NICE are involved in developing the guidance:
The Public Health Advisory Committee (PHAC) for the prevention and/or early identification of a condition – the CPHE manages the Committee.
The GDG for clinical management – the NCC manages the GDG and reports to the GCM in the CCP.
On occasion it may be appropriate to form one joint development group, for example for updating combined guidance.
A joint steering group is established from the outset to coordinate the work and to monitor progress. The group is likely to include the following people:
CPHE Associate Director, lead analyst and project manager
NCC Director and project manager
a representative of the Patient and Public Involvement Programme (PPIP) at NICE.
The steering group meets at the beginning of the process and may meet every 6 months during guidance development to review progress. One of the key tasks is to decide whether the prevention and management aspects will be published as an integrated piece of guidance or as two separate pieces of guidance (public health guidance and a clinical guideline).
When the remit is received from the Department of Health or the NHS Commissioning Board, the steering group identifies key areas that will be covered in the scopes, and outlines areas of responsibility. Some issues may need to be discussed jointly by the two development groups (see section 8.3.3).
It is desirable to appoint a joint Chair for the two development groups. The Chair should have a good understanding of both public health and clinical issues. If it is not possible to appoint a joint Chair, the steering group is responsible for communication between the two groups.
Two scopes are developed: one on prevention and/or early identification, and one on clinical management. The draft scopes are consulted on at the same time and, if possible, a joint stakeholder scoping workshop is arranged. The list of stakeholders should normally be merged. The final scopes are agreed by the steering group, and should clearly define the issues that will be addressed under prevention and those that will be addressed under clinical management. All prioritised topics must be covered in either the prevention scope or the clinical management scope. Stakeholder comments are responded to separately by the CPHE and the NCC scoping groups, but the steering group meets to agree consistency between responses.
Early in the process (preferably during scoping), the steering group ratifies the decisions made about membership of the GDG (the PHACs are standing advisory committees) and makes a final decision on whether there should be overlapping membership. The development groups work to a joint timetable, but follow the processes and methods set out by the CCP and CPHE respectively. Although the PHAC and GDG meetings are held separately, it is helpful if there is at least one joint meeting during development to ensure consistency and to avoid overlaps or gaps.
The draft clinical guideline and public health guidance are normally consulted on at the same time, using the usual consultation processes of the CCP and CPHE respectively. Stakeholder comments are categorised as relating to prevention or clinical management, or as joint comments. Responses are drafted by each project management team in the CPHE and the NCC, and discussed by the joint steering group before being finalised by the two groups.
It is important that there is early discussion with the steering group and with the editorial and communications teams at NICE about how the final guidance is presented. The editorial team should agree the proposed format with the two development groups early in the process, and should also agree the proposed recommendations after editing at a joint meeting with the two groups if possible. The two parts of the guidance are published at the same time as a pair.
Two further programmes have been developed at NICE, within the CHTE. These are the Medical Technologies Evaluation Programme and the Diagnostics Assessment Programme. These programmes develop guidance on innovative medical devices and diagnostics, normally at an early stage in their use in the NHS.
The interactions between these new guidance programmes and other NICE guidance programmes are at a relatively early stage. NICE has implemented systems for liaison across programmes to support the efficient development of consistent, implementable guidance.
Medical technologies guidance considers a single medical device or diagnostic technology that provides at least equivalent clinical outcomes for equivalent or reduced cost, compared with technologies in current use.
The Medical Technologies Evaluation Programme (MTEP) process and methods guides are available on the NICE website.
If the guideline scoping group identifies a key clinical issue for the guideline where there is published medical technologies guidance, the CCP will discuss with the MTEP team how this will be approached within the guideline during consultation on the guideline scope. The CCP and the MTEP will write a joint paper for NICE Guidance Executive describing the proposed approach.
Assuming that the topic remains in the final scope, the CCP will brief the MTEP of the GDG's views as soon as the draft recommendations are available. The CCP and the MTEP will then decide on the relationship between the recommendations for the different programmes, consulting Guidance Executive if appropriate.
The NCC will check the medical technologies guidance publication list for both published and 'in development' guidance during the guideline development phase. If a clinical guideline is already in development when a relevant notification is received, the MTEP will pass the finalised scope(s) for the relevant procedure(s) to the CCP at NICE. This will allow appropriate planning and cross-referencing between the two programmes.
If medical technologies guidance in development has not been finalised at the time of the guideline consultation, the medical technologies consultation document should be listed in the 'Related NICE guidance' section of the guideline.
When a newly notified technology has been scoped and it has been agreed that it will be assessed by the MTEP, and a clinical guideline is already being developed in this area, the MTEP team will inform the NCC and the NICE GCM that the notified procedure is relevant to the guideline, but the technology will not form part of the clinical guideline.
Diagnostics guidance helps to ensure that the NHS is able to adopt clinically and cost-effective diagnostic technologies rapidly and consistently.
The programme assesses all types of measurements and tests that are used to evaluate a patient's condition, such as physiological measurements, laboratory tests, pathology tests, imaging tests and endoscopy. Diagnostic technologies may be used for various purposes, such as diagnosis, clinical monitoring, screening, treatment triage, assessing stages of disease progression and risk stratification.
Diagnostics guidance considers one or more diagnostic technologies that are claimed to provide improved clinical outcomes at additional cost, compared with diagnostics in current use. The aim of the evaluation is to consider whether the products under consideration are cost-effective.
The NICE Diagnostic Assessment Programme manual is available on the NICE website.
If the guideline scoping group identifies a key clinical issue for the guideline where there is published diagnostics guidance, the CCP will discuss with the Diagnostic Assessment Programme (DAP) team how this will be approached within the guideline during consultation on the guideline scope. The CCP and the DAP will write a joint paper for NICE Guidance Executive describing the proposed approach.
Assuming that the topic remains in the final scope, the CCP will brief the DAP of the GDG's views as soon as the draft recommendations are available. The CCP and the DAP will then decide on the relationship between the recommendations for the different programmes, consulting Guidance Executive if appropriate.
The NCC will check the diagnostics guidance publication list for both published and 'in development' guidance during the guideline development phase. If a clinical guideline is already in development when a relevant notification is received, the DAP will pass the finalised scope(s) for the relevant diagnostics to the CCP at NICE. This will allow appropriate planning and cross-referencing between the two programmes.
If diagnostics guidance in development has not been finalised at the time of the guideline consultation, the diagnostics consultation document should be listed in the 'Related NICE guidance' section of the guideline.
When a newly notified diagnostic has been scoped and it has been agreed that it will be assessed by the DAP, and a clinical guideline is already being developed in this area, the DAP team will inform the NCC and the NICE GCM that the notified diagnostic is relevant to the guideline, but it will not form part of the clinical guideline.
 Information throughout this manual relating to the role of the National Collaborating Centres in guideline development also applies to the Internal Clinical Guidelines Programme at NICE.