Title: NICE Decision Making Dr Katherine Payne North West Genetics Knowledge Park The University of Manchester katherine.payne@manchester.ac.uk
1NICE Decision MakingDr Katherine PayneNorth
West Genetics Knowledge ParkThe University of
Manchester katherine.payne_at_manchester.ac.uk
2National 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 - medicines
- medical devices
- diagnostic techniques
- surgical procedures
- health promotion activities
3Why 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
4Medicines regulation in the UK
- MHRA
- EMEA
- Use quality, safety, efficacy data but no
economic evidence
- 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
- 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 gt 6 months
5NICE 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
6Selecting 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
7Overview 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/commentat
ors) - Produce evaluation report
8Overview 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
9Timing of the NICE appraisal process
Coronary heart disease statins
Scope Scope published Invited submissions 1st AC Meet 2nd AC Meet 3rd AC Meet Expected completion
Dec 03 Apr 04 Aug 04 Mar 05 May 05 Jul 05 Nov 05
Inhaled insulin for types 1 and 2 diabetes
Scope Scope published Invited submissions 1st AC Meet 2nd AC Meet Expected completion
Apr 05 Jun 05 Sep 05 Mar 06 May 06 Oct 06
10Timing of the NICE appraisal process (2)
Alzheimers disease (review) donepezil,
rivastigimine, galantamine memantine
Scope Scope published Invited submissions 1st AC Meet
Dec 03 Jan 04 Jun 04 Oct 04
2nd AC Meet 3rd AC Meet 4th AC Meet Expected completion
Jan 05 Jun 05 Dec 05 tbc
11Evidence used at an Appraisal Committee
- Transparency in decision-making
- 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
12Economic evaluations
- Provide evidence about efficiency
- The comparative analysis of alternative courses
of action in terms of both their costs and
benefits.
Process of health care
INPUTS
OUTPUTS
Resources staff drugs training etc
Outcomes effectiveness QALY/utility WTP
Options 1) Drug A 2) Drug B
13The cost-effectiveness plane
Difference in cost A B Difference in QALYs
QALYs A QALYs B ICER difference in cost /
difference in QALYs
Increased cost
Most NICE appraisals
NE
NW
Increased QALYs
Decreased QALYs
SW
SE
Decreased cost
14Issues 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
15Issues in NICE decision-making (2)
- Relevant end-points (QALYs)
- Eg. Parent training for conduct disorders
- Level of uncertainty in the decision
- 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