HTA in the UK: 10 years experience of NICE Francoise Cluzeau NICE International

HTA in the UK: 10 years
experience of NICE
Francoise Cluzeau
NICE International
Some background: the NHS in the
United Kingdom
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UK NHS is free, largely, at the point of delivery and all citizens
are covered
Annual budget of £100 billion (about 160 Billion US$)
It is not perfect; universal coverage with fixed resources involves
compromises…But it provides a good level of cover
Private insurance in the UK approx. 10% and shrinking
The NHS in the late 90s…
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No quality standards
Lack of national guidance for
professionals
Unexplained/unpopular variation in care
Expensive new technologies
1997 - Government white paper
‘A new National Institute for Clinical Excellence will
be established to give new coherence and
prominence to information about clinical and
cost-effectiveness.’
So what is NICE?
The National Institute for Health & Clinical Excellence
(NICE) is the independent organisation responsible for
providing national guidance on the promotion of good
health and the prevention and treatment of ill health
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Special Health Authority – part of NHS
Budget of £61m pa, including £21m for NHS Evidence
Projected to be £87m in 2011-2012
~400 staff
Working with over 2,000 experts –physicians, nurses, health
economists, clinical epidemiologists, statisticians, lay peopleacross the UK
– Partner of EUnetHTA
Other HTA programmes in the UK
NICE is not the only organisation that conducts
HTA in the UK
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The NIHR Coordinating Centre for HTA (NCCHTA)
The Centre for Reviews & Dissemination (CRD)
Scotland (NHS Quality Improvement )
Wales (Medicines Strategy Group)
Principles of NICE guidance
• Robust
– underpinned by a comprehensive and sound evidence
base
• Inclusive
– Genuine consultation of stakeholders and expert
involvement/ contestability
• Transparent
– evidence and conclusions in the public domain
• Independent
– developed by external advisory committees
What technologies?
• Pharmaceuticals (e.g. beta-interferon for MS)
• Medical devices (e.g. hearing aids, inhalers;
insulin pumps)
• Diagnostics (e.g. liquid-based cytology)
• Procedures (e.g. surgery for morbid obesity,
repairing hernias)
• Health promotion tools (e.g. patient education
models for diabetes)
Two types of TAs
Multiple Technology Appraisal (MTA)
– run since 1999
– takes ~14 months
– Reviews, complex appraisals, classes of
technologies
Single Technology Appraisal (STA)
– run since 2006
– takes ~35 weeks
– Single technologies, single indications, close to
introduction to the NHS
All HTA recommendations to be implemented within 3
months of publication
Independent
assessment
Submissions
from consultees
4 weeks
Consultation
on evidence
13 weeks
1st Committee meeting
→preliminary
recommendations
14 weeks
Referral
MTA
4 weeks
Review
Consultation
on preliminary
recommendations
Publication
Appeal
(or not)
[14 months]
2st Committee meeting
→ final guidance
Evidence
review
Evidence
submission from
manufacturer
‘No’
‘restrictive’
8 weeks
Committee
meeting
Preliminary
recommendations
8 weeks
4 weeks
STA
Referral
‘Yes’
Consultation
Review
Final guidance
Publication
Appeal (or not)
[ 7-9 months]
Committee
meeting
Independent academic groups
• Commissioned through the NCCHTA (National
Coordinating Centre for Health Technology
Assessment, part of NHS R&D) – independent from
NICE
• Carry out systematic review and develop economic
model (MTA)
• Critique the evidence submitted by manufacturer
(STA)
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Presented in report to the Appraisal Committee
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Present at the Committee meeting to answer
questions
Independent academic centres
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Health Economics Research Unit and Health Services Research
Unit University of Aberdeen
Liverpool Reviews & Implementation Group, University of Liverpool
NHS
Centre for Reviews and Dissemination, University of York
Peninsula Technology Assessment Group (PenTAG), Peninsula
Medical School, Universities of Exeter and Plymouth
School of Health and Related Research (ScHARR), University of
Sheffield
Southampton Health Technology Assessment Centre (SHTAC),
University of Southampton
West Midlands HTA Collaboration, Department of Public Health
and Epidemiology, University of Birmingham
Appraisal Committees
• Four Standing Committees, working across the whole
spectrum of interventions and conditions
• 32 members drawn from Primary Care, Secondary Care,
Royal Colleges, Patient Groups, Health Economists, NHS
Management, Public Health, Healthcare Industries,
Biostatisticians
• Receive all evidence, expert statements and comments
• Members with a conflict of interest for a particular drug
cannot participate in an appraisal including that drug
Consultees and Commentators
(stakeholders)
• Consultees
– manufacturer/ sponsor; national professional and
patient organisations; NHS - Primary Care Trusts, DH
• Commentators
– e.g. Comparator manufacturers; relevant research
groups
• All provide comments on draft scope, the evidence, draft
guidance
• Consultees also submit evidence and have the right to
appeal
The need for economic assessment
• Recognises the reality of fixed NHS resources – and
brings this to the attention of the public
• Exposes the opportunity cost of new interventions
• Enables consistency in investment – and disinvestment
– decisions
• Helps to direct innovation into those areas regarded as
priorities by the health system
• Brings together all available data on the effectiveness,
resource use, costs, and outcomes
• Allows extrapolation to the long term if necessary
• Allows the consideration of uncertainty
Measuring quality of life - Utilities
Quality of life questionnaires included in clinical trials
– eg EQ 5D
- mobility
- self care
- pain and discomfort
- usual activities
- depression and anxiety
• Single index utility values established by asking people
to “value” a description of a particular health state
• A utility value of 0.2 = people would give up 20% of
their length of life to avoid the particular health state
Why NICE doesn’t have a fixed cost
effectiveness threshold?
Costeffectiveness
Extent of
uncertainty
NICE
Making
Judgements
DECISIONS
Potential benefits
of Innovation
Equality & Diversity
legislation
Social Value Judgements
Technology Appraisals - breakdown by
disease areas
Cancer
Cardiov ascular
Central nerv ous sy stem
Digestiv e sy stem
Endocrine, nutritional and metabolic
Ey e
Gy necology , pregnancy and birth
Infection
Infectious diseases
Injuries
Mental health and behav ioural conditions
Metabolic and Endocrine
Mouth and dental
Musculoskeletal
Respiratory
Skin
Surgical procedures
Urogenital
Breakdown of recommendations
Comparison of all vs cancer technologies
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40
all %
cancer %
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20
10
0
yes
partical yes
OIR
not recommended
Technology appraisals: outputs
Technology appraisal decisions
Decision
Number
Percent
Unrestricted
98
29%
‘Yes’ with restrictions’
188
55%
Only in Research
21
6%
Not recommended
31
9%
Non-submission
4
1%
Total
342
100%
84% of our
advice
recommends
use…
342 individual recommendations in 160 technology appraisals
Statin uptake
In the press
Not everybody is happy with our decisions
Alzheimer's Society, London 2006
Vol 372, Aug 23, 2008
End of life drugs: New development
• Concern that life-extending treatments (e.g. cancer) are
undervalued by the appraisal process
• And… Almost 1 in 3 drugs trough STA process are
cancer drugs
• In January 2009 NICE issued supplementary advice to
Appraisal Committees
• Sets out criteria for appraisal of end of life treatment
with an incremental cost effectiveness ratio (ICER)
above the upper end of the range normally approved by
the Appraisal Committees
Ongoing issue: the threshold
• Should the QALY threshold be raised?
ØYes - NICE should base its decisions on the
public’s willingness to pay.
ØNo - The threshold should be based on
opportunity costs in terms of displaced
interventions
• NICE should develop a disinvestment programme
based on identifying treatments with poor cost
effectiveness
• Ongoing work: the ‘threshold-searcher’
Recent developments in technology
appraisal: pricing and access
• The UK’s voluntary Pharmaceutical Price Regulation
Scheme (PPRS) has been revised in 2009 with two
new elements to better reflect value in the price of
drugs:
• Flexible pricing: will allow a company to increase or
decrease its original list price when new evidence
emerges concerning the drug’s efficacy or risks, or a
different indication is developed;
• Patient access schemes: can facilitate patient access
for medicines that were not initially found to be cost- or
clinically effective by NICE.
“NICE has been widely debated and often critized since its
inception in 1999. However it can claim several major
achievements and still represents one of the more
sophisticated attempts to integrate HTA into the
decision making process”
Michael Drummond & Corinna Serenson,
Value in Health, 2009