How NICE works
163. Topics are selected for technology appraisals
and clinical guidelines by Ministers and the Welsh Assembly.
Topic selection is a three-stage process, of which the first stage
is the identification of a pool of potential topics NICE might
consider. According to the Department of Health, the 'pool' of
topics for technology appraisals is influenced by: new technologies
identified by the National Horizon Scanning Centre, a unit of
the University of Birmingham, which is funded by the NHS R&D
programme; topics suggested by professional and patient groups
and by the wider NHS; proposals from the National Clinical Directors
and other Department of Health (DH) or National Assembly for Wales
(NAW) policy branches; and completed research carried out under
the auspices of the National Health Technology Assessment programme.
Topics for clinical guidelines are informed largely by the needs
of the National Service Frameworks.
164. Suggestions for technology appraisals are considered
by the Technologies Advisory Group. The membership of this group
is not published, but is "mainly staffed by officials in
the Department of Health and National Assembly for Wales",
with representatives from NICE.
Topics for clinical guidelines are considered by the Clinical
165. The topic lists proposed by the Technologies
Advisory Group and the Clinical Priorities Group are then put
forward to the Joint Planning Group, a smaller group jointly chaired
by the Chair of NICE and by a senior Department of Health official,
which considers logistical and capacity issues for NICE's work
programme, and 'signs off' a final recommendation to the Minister
and National Assembly for Wales.
The technology appraisals process
166. Once a technology is referred to NICE, staff
begin the appraisal process by identifying formal consultees.
These will include the Department of Health and National Assembly
for Wales, the manufacturers or sponsors of the technology, relevant
national, professional organisations, and national patient organisations.
Consultees will also include the Health Technology Board for Scotland
and two health authorities, although these organisations do not
have a right of appeal.
167. NICE then conducts a literature search and prepares
a draft scope, aiming to identify all the relevant questions and
issues the appraisal should address. Prior to publication, a draft
version of this is sent to all consultees for comment.
168. On behalf of NICE, the NHS Co-ordinating Centre
for Health Technology Assessment (NCCHTA), which is run by the
NHS Research and Development Programme, commissions an assessment
report based on the final scope, usually from one of a number
of academic centres known as Health Technology Assessment Units,
which are part of the NHS R&D programme. Once completed, this
is sent to all consultees who are given ten working days to comment
on it. In tandem with this, all consultees have 16 weeks in which
to make submissions to NICE setting out their views on and experiences
of the technology under appraisal. NICE staff then compile the
evidence, including the assessment report and consultee submissions,
into what is known as the 'evaluation report', which is submitted
for consideration by the Appraisal Committee.
169. Four patient representatives and two clinical
experts, nominated by the formal consultees and selected by the
Chairman of the Appraisal Committee, are invited to attend a Committee
meeting at which they are 'given the opportunity to make observations
about the technology and its use in the NHS'. This is usually
followed by questions from the Committee, and if the patient representatives
and clinical experts wish they may support their oral contribution
with a 'written perspective' on the technology under appraisal.
The Appraisal Committee then discusses the evaluation report and
the drafting of the Appraisal Consultation Document (ACD) in private.
170. The ACD is then sent together with the assessment
report to all consultees for a four week consultation period.
Following this period, the Appraisal Committee meets a second
time to consider the original evidence and the ACD in the light
of any comments made by consultees, and to agree the Final Appraisal
171. Following the circulation of the FAD, all consultees
except the Health Technology Board for Scotland and the NHS health
authorities have a 15 day period in which to lodge an appeal.
Appeals may only be made on one or more of the following grounds:
- The Institute has failed to act fairly and in
accordance with its published procedures
- The Final Appraisal Determination is perverse
in the light of the evidence submitted
- The Institute has exceeded its powers.
172. The decision about whether or not an appeal
should be heard is taken by the Chair of NICE. An Appeal Panel
constituted of five members is then appointed from NICE's Appeals
Committee, all of whom will have had no involvement in the appraisal.
The Panel is chaired either by the Chair of NICE or another member
of the NICE board.
173. Following the appeal period, guidance on the
use of the technology is then issued to the NHS.
The Clinical Guidelines development process
174. When a topic is selected, NICE publicises this
and asks potential stakeholders to register their interest via
the NICE website. Those that register will be consulted during
the guidelines development process.
NICE's National Guidelines and Audit Patient Involvement Unit
supports the involvement of patients and carers who register.
175. Scoping is then carried out by the relevant
National Collaborating Centre (NCC), who propose the patient groups
that will be considered, the healthcare setting, the range of
treatments to be assessed and how the Centre will assess the clinical
and cost effectiveness. The scoping assessment is then circulated
for comment to stakeholders and to the
Guidelines Advisory Committee Panel. The NCC then
submits a workplan for developing the guideline which, together
with the final scope and timetable, is posted on the website.
176. The development of the guideline is the responsibility
of the relevant NCC. The NCC will establish a Guideline Development
Group which carries out the developmental work, identifying and
assessing different types of evidence, and then formulating recommendations
for practice on the basis of its evaluation of the evidence.
177. Once the Guideline Development Group has made
its recommendations, the National Collaborating Centre prepares
draft versions of the full guideline, short form guideline and
patient information leaflet. There are two rounds of formal consultation
with documents sent for comment to the Guidelines Advisory Committee
and to stakeholders. Redrafted versions are posted on NICE's website
during the second period of consultation. The final set of documents
is signed off by the Guideline Development Group, the Guideline
Advisory Committee and finally by NICE itself. There is no procedure
for appealing against the recommendations of a Clinical Guideline.
NICE and the wider quality agenda
178. NICE does not operate in isolation, but forms
one part of the Government's wider 'quality' agenda. Set out in
A First Class Service, this also included the establishment
of national clinical standards through National Service Frameworks.
The delivery of these standards is effected through the clinical
governance programme, and their monitoring is carried out by the
Commission for Health Improvement. National Service Frameworks
(NSFs) provide a wider framework of standards for service delivery
in key clinical areas, sometimes including maximum waiting times,
and have so far been issued in the areas of mental health, coronary
heart disease, services for older people, and diabetes. NSFs are
currently being developed for children's services, renal services
and long term conditions.
179. The Commission for Health Improvement was established
in April 2000, and has embarked on a programme of reviews of clinical
governance in NHS Trusts and Health Authorities, with the aim
of having reviewed all NHS organisations by 2004. CHI reviews
currently examine the arrangements NHS organisations have in place
for implementation and monitoring of NICE guidance, although they
do not conduct detailed audit of their implementation.