NICE, medtech and evidence
Mrs Mirella Marlow MA MBA
Programme Director
MediWales
11 December 2012
Contents
• General information about NICE
• What do medtech products need to “prove”?
• How NICE works with medtech companies
• clarifying value propositions
• supporting development of evidence
• enhancing Health Technology Assessment (HTA)
skills
About NICE
• National Institute for Health and
Clinical Excellence
• Established in 1999 to reduce
variation in the availability and
quality of NHS treatments and
care
• Guidance and evidence to
support the health service and
local authorities
• Independent of government
• New responsibilities from April
2013 – social care
2012 NICE products & services
BRAND MAP HERE
How can innovative medtech products
help? (1)
One-off
device
implant
Speed
up
recovery
Reduce
length of
stay
System
benefits
Reduce
hospitalisation
Different
staff
grade or
type
How can innovative medtech products
help? (2)
Decision
or care
nearer
home
Enable
self
care
Improve
compliance
Patient
benefits
Reduce
unnecessary
interventions
Enhance
dignity
NICE works with companies
Pre-evaluation
• Engagement team works with companies incl. SMEs
• Changing the view of the value proposition
• Encouraging development of evidence
• Exploring pipeline, focusing on clinical utility
How does NICE identify medical
technologies for evaluation?
Device
Test
Companies
notify
topics to
NICE
Medical Technologies Advisory Committee
Medical technology
guidance (MTEP)
Diagnostics guidance
(DAP)
Tech Appraisals
guidance (TAP)
NICE value proposition options
Clinical
performance
Better
Non-inferior
Cost
Higher
Less overall
Cost effectiveness (QALY)
Costs
consequences
(QIPP)
Evaluation
method
NICE guidance
programme
Technology
Appraisals
Programme
(TAP)
Diagnostics
Assessment
Programme
(DAP)
Medical Technologies
Evaluation
Programme (MTEP)
Technologies
 Devices
 Diagnostics  Devices
 Diagnostics
Medical technologies guidance:
‘relevant’ evidence
• Sponsor submission
‒ Published and in-press trials
‒
‒
‒
‒
‒
Unpublished data
Regulatory data
Post-market register data, audits and ‘real-life’ experience
Forthcoming trial results
Planned trials in a reasonable timeframe
• Cost model
• Expert advice – clinical/patient
………Must support sponsor’s claim
NICE’s assessment of value
• Standard clinical evidence and health economic
techniques
‒ Clinical evidence – systematic reviewing and
meta-analysis, linked evidence approaches etc
‒ Health economics – modelling, sensitivity analysis
etc
• World class academic assessment groups and
external assessment centres
• Regular review of technical methods with
stakeholders
• Further development of technical methods (e.g. MRC
funded activities)
NICE medtech recommendations
Evidence shows
sufficient certainty of
benefit
Product has potential to
provide substantial
benefits, but uncertainty
about whether these are
realisable in normal
clinical settings
Significant
uncertainty, or
certainty of no
benefit
Case supported
Adoption optimised
OR
Research recommended
Case not supported
Use (with standard
NICE implementation
or “deeper” adoption
support - NTAC)
Use in subgroup
OR
NICE/EAC supports
development of
evidence
Not for current use
Collaborating for better evidence
Pre-evaluation:
Advise companies to
work with NOCRI on
pipeline products
Post-evaluation:
Access to research
facilitation for products
with a research-only
recommendation
Pragmatic randomised controlled
trial of MIST ultrasound therapy
compared to UK standard care for
the treatment of non-healing
venous leg ulcers
Scientific advice seminars - medtech
• For developers and investors
• What is meant by value from the perspective of NICE?
• Know how your value proposition links to the need for
specific evidence
• What is meant by cost effectiveness?
• Types of evidence considered by NICE
• General principles of health technology assessment
(HTA)
Further information
• NICE website: www.nice.org.uk
• Contact the NICE medtech team:
medtech@nice.org.uk
• Apply to attend a NICE medtech seminar:
adviceseminars@nice.org.uk