Assessing the value proposition and promoting the adoption of new and novel medical technologies

1. Assessing the value proposition and promoting the adoption of new and novel medical technologies Mark Campbell Associate Director Medical Technologies Evaluation Programme (MTEP) CE 2012: EU Medical Device Regulatory Revision Conference Birmingham, 20 September 2012

2. Content • General update on NICE • Development and operation of the NICE medtech programmes • Assessing value • Published and in-development guidance

3. http://review2011-2012.nice.org.uk/

4. A short history of NICE Diagnostics Publications Medical devices NHS Evidence accreditation decisions Interventional Procedures Quality standards QOF Clinical guidelines Public health

5. NHS Chief Executive Report on Innovation - December 2011

6. Innovation, health and wealth:promoting uptake of NICE guidance • Support for adoption of NICE guidance • Compliance regime and uptake metrics • End to local duplication of NICE evaluation • Support for the NICE scientific advice programme • Targeted effort to implement dementia and oesophageal Doppler monitoring guidance • Immediate transfer of DH Innovative Technology Adoption and Procurement Programme(iTAPP) to NICE

7. “...Through its medtech progammes, which use world-leading methodologies, NICE is at the forefront of helping decision-makers derive maximum value for the NHS;and we look forward to continuing to develop these with clinicians, policy-makers and industry..”Professor Sir Michael RawlinsChairman, NICE http://jrsm.rsmjournals.com/content/105/suppl_1.toc

8. Regulation or evaluation ?

9. Medical Technologies Evaluation Programme (MTEP) bespoke design (1) Appl Health Econ Health Policy 2012; 10 (5): 295-297

10. Medical Technologies Evaluation Programme (MTEP) bespoke design (2)

11. NICE medtech programmes (MTEP, DAP) at-a-glance

12. Scope – products to be evaluated • Medical devices as defined in EU directives: • 93/42/EEC (concerning medical devices) • 98/79/EC (concerning in vitro diagnostic medical devices) • 90/385/EEC (concerning active implantable medical devices), as amended • …..including medical devices used for the purpose of diagnosis…and medical software • Genetic tests within the scope of 98/79/EC provided they have a medical purpose • Other products (eg tissue engineered products), on advice from DH

13. The case for adoption (compared with standard care) • Replace ongoing therapy costs with one-off intervention or device • Deliver treatment decision or care nearer to home • Reduce unnecessary surgical interventions • Enable self-care • Reduce length of stay • Enable treatment by a lower grade or less scarce type of staff • Improve patient dignity and treatment compliance • Reduce future hospitalisation • Speed up recovery • Etc

14. Eligibility and selection criteria Plausible promise Ineligible or not-selected topics are returned to the sponsor with a summary of the Committee’s considerations

15. Routing selected topics:what’s the value proposition ?

16. Which programme at NICE?

17. Cost modelling – cost consequences analysis

18. MTG recommendations • Usually: • Case supported (wholly, partly or not) • Consider using in <case for adoption> <research> • Resource consequences • NICE medical technology guidance addresses specific technologies notified to NICE by manufacturers. The ‘case for adoption’ is based on the claimed advantages of introducing the specific technology compared with current management of the condition. This ‘case’ is reviewed against the evidence submitted and expert advice. If the case for adopting the technology is supported, then the technology has been found to offer advantages to patients and the NHS. The specific recommendations on individual technologies are not intended to limit use of other relevant technologies which may offer similar advantages.

19. Development of further evidence • MTEP has a research workstream as an integral part of programme • Designed to facilitate research to address gaps in evidence which led to research recommendations in MTG or DG • Flexible approach to research products but must be able to be completed within ~ two years • Subject to findings and evaluation – updated guidance

20. Assessing value

21. What do decision makers need to know about new technologies? Product value

22. What you need to do – constructing claims and driving value A point-of-care diagnostic test which allows 'test and treat' A test which confirms or excludes serious illness more quickly and/or more accurately allowing faster targeted treatment/faster discharge A device which enables people to be more independent A device which allows more accurate and/or more convenient monitoring (and therefore shorter or no time in hospital or fewer hospital visits) An imaging technology which allows a reduced radiation dose and/or more accurate imaging and/or better treatment planning or monitoring

23. Common pitfalls and....some solutions

24. Getting help Evidence generation - NIHR NOCRI www.nocri.nihr.ac.uk Relevant evidence for health technology assessment - NICE Scientific Advice www.nice.org.uk General support for innovation - Technology Strategy Board/ Knowledge Transfer Networks www.innovateuk.org

25. December 2011

26. Published and in-development guidance11 MTG published, 9 in development5 DG published, 7 in development

27. Patient and system benefits of published guidance

28. BBC News at 10: 29 March 2011

30. Latest news on MTG5 - August 2012

33. Thanks for listeningwww.nice.org.uk/mtNotify a technology:medtech@nice.org.uk