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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 - PowerPoint PPT Presentation
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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
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?
Medical technology guidance (MTEP)
Diagnostics guidance (DAP)
Tech Appraisals guidance (TAP)
NICE value proposition options
Clinical performance Better Non-inferior
Cost Higher Less overall
Evaluation method Cost effectiveness (QALY)
Costs consequences
(QIPP)
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‒ Unpublished data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 supportedAdoption optimised
ORResearch 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:
[email protected]• Apply to attend a NICE medtech seminar: