1. NICE, medtech and evidence Mrs Mirella Marlow MA MBA Programme Director MediWales 11 December 2012

2. 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

3. 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

4. BRAND MAP HERE 2012 NICE products & services

5. How can innovative medtech products help? (1) System benefits One-off device implant Reduce length of stay Different staff grade or type Reduce hospital- isation Speed up recovery

6. How can innovative medtech products help? (2) Patient benefits Decision or care nearer home Enable self care Enhance dignity Reduce unnecessary interventions Improve comp- liance

7. 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

8. How does NICE identify medical technologies for evaluation? Companies notify topics to NICE Test Device Medical Technologies Advisory Committee Medical technology guidance (MTEP) Diagnostics guidance (DAP) Tech Appraisals guidance (TAP)

9. NICE value proposition options Clinical performance BetterNon-inferior Cost HigherLess 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

10. Medical technologies guidance: ‘relevant’ evidence Sponsor submission ‒ Published and in-press trials ‒ Unpublished data ‒ Regulatory data ‒ Post-market register data, audits and ‘real-life’ experience ‒ Forthcoming trial results ‒ Planned trials in a reasonable timeframe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

11. 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)

12. 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 evidenceNot for current use

13. 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

14. 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)

15. 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