NICE, medtech and evidenceMrs Mirella Marlow MA MBAProgramme Director

MediWales11 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

BRAND MAP HERE

2012 NICE products & services

How can innovative medtech products help? (1)

How can innovative medtech products help? (2)

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‒ Unpublished data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:

medtech@nice.org.uk• Apply to attend a NICE medtech seminar:

adviceseminars@nice.org.uk