1. How will we know whether this technology is appropriate? OR New procedures, NICE and Specialist Societies Bruce Campbell Chairman NICE Interventional Procedures Advisory Committee BCIS 30 th January 2009

2. Advanced Cardiovascular Intervention 30 th January, 2009 No conflicts to declare

3. I have been asked to cover NICE perspective on introducing new technologies Processes leading up to IPGs and TAs Tracking effectiveness (e.g. TAVI) Specialist Societies – Training/audit

4. NICE Guidance Technology Appraisals –Clinical and cost effectiveness –Mandate for funding Clinical Guidelines Interventional Procedures –Safety and efficacy –Not cost No mandate to fund Public Health

5. NICE guidance and new procedures - an ideal 1.Research – provides initial data>>> 2.IP guidance - safety and efficacy (perhaps more data collection)>>> 3.Technology Appraisal – clinical and cost effectiveness>>> 4.Clinical guideline - place in management strategy

6. Source of topics/procedures TECHNOLOGY APPRAISALS Topic Selection Panel >>> debate Formal referral from DH – list available INTERVENTIONAL PROCEDURES Via NICE website From clinicians, industry, patients, others Does procedure fit the Programme’s remit?

7. Remit of the NICE IP Programme Procedures used for diagnosis or treatment that involve: –incision, puncture or entry into body cavity –ionising, electromagnetic, acoustic energy First use in the NHS (or private sector) New concerns about efficacy or safety Procedures not specific devices

8. Evidence used by IPAC Published studies (not normally abstracts) Specialist Adviser information/views Patient comments Committee Members’ knowledge Some differences for TAs Submissions from stakeholders Clinical Specialists & Patient Experts attend ………public attend both

9. What to recommend when evidence for IP is inadequate? “Special Arrangements” for: Governance – tell your hospital Consent - tell your patients Audit/research – review your outcomes

10. Possible “1.1” recommendations “Normal arrangements” “Special arrangements” Research only Do not use

11. Other recommendations Teams/units – very careful Training – need specialist collaboration Data collection - but practical difficulties Research needed - specify outcomes

12. Public consultation Seldom disagreement with recommendations Common responses: –Technical details –Indications –Selected centres only –More detail on consent All considered: often stimulate changes

13. Registers – our aspirations Data collection for procedures with uncertain evidence & “cautious” guidance Existing databases if appropriate, or Limited datasets focussed on data needed for NICE IP review Funding linked to data submission

14. NICE IP guidance and CCAD Guidance recommends submission (18) BUT - CCAD may not have specific field AND – we need relevant data for review AND – CCAD data may be incomplete

15. CCAD vs HES data on Percutaneous Closure of PFO 2007-8: CCAD - 332 procedures from 23 hospitals HES - 632 procedures from 35 hospitals (manufacturer data support HES)

16. Data collection on TAVI “Cautious”guidance because: Efficacy: small numbers and short term Safety: potential for serious complications SUBMISSION TO CCAD RECOMMENDED NICE collaboration with CCAD Need some PROMs as well as objective data Funding: perennial problem/precedent

17. Thanks to all involved with CCAD NICE committed to collaboration

19. Training workshop consensus NICE + SOs should identify procedures and NICE should make training recommendations SOs should define skills, standards, strategy Supporting framework necessary Manufacturers make valuable contributions Audit data inform review and “benchmark” NICE should request more detail from SAs SOs – Specialist Organisations SAs – Specialist Advisers