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NICE Decision Making
Dr Katherine Payne
North West Genetics Knowledge Park
The University of Manchester
[email protected]
National Institute for Health and
Clinical Excellence (NICE)
• Est. April 1999
• ‘Health’ added April 2005
• To provide guidance on the clinical and
cost-effectiveness of new and existing
health technologies in the NHS in England
and Wales
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medicines
medical devices
diagnostic techniques
surgical procedures
health promotion activities
Why do we need national guidance?
• NHS must be provided with a fixed
budget → choices
• Health technology assessment, medicines
evaluation and the NHS
• Local versus national decision-making
– Medicines Management Committees
– NICE
• Variation in decisions
• A centralised decision-making body
Medicines regulation in the UK
• MHRA
• EMEA
Use quality, safety, efficacy data but no economic evidence
COX-2 selective NSAIDs:
• RCTs agent compared with
placebo or traditional
NSAIDs
• Outcomes used:
endoscopic ulcers
• Patients with GI and CV risk
excluded
• No trial > 6 months
In practice:
• Used instead of PPIs,
misoprostol or H2RAs
• Outcomes needed:
symptomatic ulcers, GI bleeds,
QoL, costs
• Patients with GI and CV risk
• Used for many years
NICE guidance
• Technology appraisals
new and existing medicines and treatments (94)
• Clinical guidelines
specific diseases and conditions (42)
• Interventional procedures for diagnosis or
treatment (from Feb 02)
safety and efficacy of surgical procedures (145)
• Public health interventions and programmes
Also ……
Clinical Audit and Referral Advice for the NHS
Selecting technologies for appraisal
• Is the technology likely to result in a:
– significant health benefit
– relates to NHS clinical priority areas or
government health-related policies
– condition has significant disability, morbidity
or mortality
– significant impact on NHS resources
(financial or other)
– added value by issuing national guidance
Overview of the NICE appraisal process (1)
• Preparation of the ‘scope’
• Consultees (patient/carers groups, healthcare
professionals, manufacturers) input
• Commentators (manufacturers of comparator
technology, research groups) input
• Prepare ‘assessment report’
(academic centre)
• Comment on assessment report
(consultees/commentators)
• Produce evaluation report
Overview of the NICE appraisal process (2)
• Appraisal Committee meet 1:
Evaluation report plus verbal evidence
Appraisal Consultation Document (ACD)
• Appraisal Committee meet 2:
Comments submitted on ACD
Final Appraisal Determination (FAD)
• Consultees can appeal against FAD
• If no appeals:
FAD forms basis of NICE guidance
• Start to end of appeal period:
minimum 54 weeks
Timing of the NICE appraisal process
Coronary heart disease – statins
Scope
Scope
published
Invited
1st AC
submissions Meet
2nd AC
Meet
3rd AC
Meet
Expected
completion
Dec 03
Apr 04
Aug 04
May 05
Jul 05
Nov 05
Mar 05
Inhaled insulin for types 1 and 2 diabetes
Scope
Scope
published
Invited
1st AC
submissions Meet
2nd AC
Meet
Expected
completion
Apr 05
Jun 05
Sep 05
May 06
Oct 06
Mar 06
Timing of the NICE appraisal process (2)
Alzheimer’s disease (review) –
donepezil, rivastigimine, galantamine & memantine
Scope
Scope
published
Dec 03 Jan 04
Invited
submissions
1st AC
Meet
Jun 04
Oct 04
2nd AC
Meet
3rd AC
Meet
4th AC
Meet
Expected
completion
Jan 05
Jun 05
Dec 05
tbc
Evidence used at an Appraisal Committee
Transparency in decision-making
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Epidemiological: how many patients?
Clinical evaluations (RCTs, meta-analyses)
Economic evaluations
Expert clinician and patient views
Manufacturers submissions
(commercial in confidence data)
Quality of evidence
Strength of effect
Risk of adverse events
Evidence of patient value
Availability of alternative treatment
Economic evaluations
• Provide evidence about ‘efficiency’
• The comparative analysis of alternative courses
of action in terms of both their costs and
benefits.
INPUTS
Resources:
staff
drugs
training
etc
Process of
health care
OUTPUTS
Options:
Outcomes:
1) Drug A
effectiveness
2) Drug B
QALY/utility
WTP
The cost-effectiveness plane
Difference in cost = £A – £B
Difference in QALYs = QALYs A – QALYs B
ICER = difference in cost / difference in QALYs
Increased cost
NW
NE
Decreased QALYs
Most NICE appraisals
Increased QALYs
SW
SE
Decreased cost
Issues in NICE decision-making (1)
• Transparency in appraisal and evidence
base
• The scope: individual medicines or
class/groups?
• Evidence appropriate to the patient
population
• Generalisability from setting to setting
– Eg. glycoprotein 3b/2a inhibitors in heart disease
• Long-term follow-up data
Issues in NICE decision-making (2)
• Relevant end-points (QALYs)
– Eg. Parent training for conduct disorders
• Level of uncertainty in the decision
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Bias in data
Poor data
No data
Eg. risk-sharing and beta interferon
• NICE does not have a ‘cost per QALY’ threshold
• NICE and its value judgements
– Scientific
– Social