1. SMC Evaluation Programme

2. Overview Context Evaluation Programme –Stakeholders –SMC advice Conclusions

3. Context SMC established October 2001 SMC first advice April 2002 Remit To provide advice to NHS boards and their ADTCs across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines and new indications for established products

4. Assessment process Proforma Pharmacy assessment Team Health Economics group NDCSMC Submitted by company Critical Appraisal of submission Scientific Advisory Committee Company response Patient group Advice in context of NHS Scotland

5. Evaluation Programme 1.Stakeholders 2.SMC advice

6. Programme Delivery Structure –Project Team –Management Group –Reference Group –SMC Executive Team Timescale –2 year programme (April 06 - March 08)

7. Stakeholders

8. Stakeholders – methods 1 Impact on ADTCs role and function 2000 2002 2003/4 + + 2006/7 Review of Public information Workshop June 2007 ADTCs n~ 60

9. Stakeholders – methods 2 Engagement with stakeholders Pharmaceutical Industry Workshop (n~100) Public Partners* Postal questionnaires and interviews (n=154) ++ ADTCs Workshop (n~60 ) * ScotCen – Scottish Centre for Social Research

10. Stakeholders - Key Findings Impact on ADTCs’ role and function Theme Medicines Reviewed Structures and processes Implementation / Communication Evaluation and monitoring Evidence of consistency 2000 Variable: 3-91 per annum Move from Trust to ADTCs Variation in discipline membership and skill set Variable from clinician feedback to formulary inclusion Challenging due to resources available Variation in decisions made by NHS Boards 2006/7 All SMC advice Continual evolving structures Variable discipline membership Formulary management well established (move from lists to pathways). More use of IT Using available local and national data were possible. Little evaluation of impact of changing processes Clarity of handling of SMC ‘not recommended’ advice Local decision systems for handling accepted /restricted SMC advice

11. Key Findings Engagement with Stakeholders ADTCsPublic PartnersPharmaceutical Industry Successes of engagement with SMC  Single source of timely advice  Reduction in ADTC evaluation of primary evidence  Quite successful where understood by groups  Robust, transparent processes  Industry recognised as partner Challenges of engagement with SMC  Non submission to SMC  Clarity for media and patients of the role of local formularies  Limited awareness at time of survey of SMC (41%), its website and processes (33%)  Variation in how NHS boards implement advice  Lack of awareness of how companies contact industry reps on SMC Improving engagement with SMC  Succession planning for SMC members  Evaluation of selected medicines licensed before SMC  E-mail to inform groups of relevant medicines  Inviting groups to attend SMC  Earlier access to economic checklist  Collaboration with other HTA organisations to reduce duplication

12. SMC Advice

13. Sampling Frame

14. SMC Advice – method 1 Medicine Profiles ( n=74) Not Recommended - 20/57 (35%) Accepted / Restricted – 54/149 (36%)

26. SMC Advice – method 2 Case study – Etanercept –Medicine use in psoriatic arthritis –Implementation of SMC Etanercept Protocol (Aug 2006) Budget Impact – Compare estimate and actual spend (n=28) – Focus group to understand how NHS boards use this information

27. SMC Advice – Key Findings Not Recommended advice (n=20) 65% of advice issued within 6months of medicine launch date Use before SMC advice (n=20) –£1.4m ( context - £3.7billion) Use after SMC advice 2005/6 (n=10) –£1m ( 0.1% of drugs bill )

28. SMC Advice - Key Findings SMC not recommended advice (n=20)

29. Limited use relative to alternative treatments

30. Variation in advice issued by national bodies to NHS boards and clinicians

31. Lack of engagement of relevant clinical experts in early stages of SMC

32. SMC Advice - Key Findings SMC accepted/restricted advice (n=54) 81% of advice issued within 6 months Use before SMC advice ( n=41) –£1m (context £3.7billion) Insufficient robust data for hospital medicines

33. updateSMC Advice - Key Findings SMC accepted/restricted advice (n=54)

34. Comparison of hospital and industry data

35. SMC Advice – Case Study

36. SMC Advice - Key Findings Etanercept Table 1: SMC etanercept protocol – Adherence of NHS boards in Scotland at August 2006

37. SMC advice - Key Findings Budget Impact Reliability of budget impact estimates –Unable to meaningfully compare data due to series of factors Experience of NHS Boards’ use of information –Budget information valued by NHS Boards for local planning –Further clarity and definition required to improve quality

38. Conclusions - Successes ADTCs have adapted and evolved in response to SMC SMC has good engagement with ADTCs and Pharmaceutical Industry Budget impact information is valued by NHS boards

39. Conclusions – Challenges Effective engagement with public partners remains a challenge Monitoring use of medicines is limited by availability of robust hospital medicines data and lack of patient level data

40. Conclusion – Future Direction Actions based on the factors identified which help to explain medicine use Development of a more consistent approach to budget impact estimates Actions based on findings from public partners Continued development of effective methodologies to assess the contribution of HTA organisations to patient care

41. Acknowledgements The project team Marion Bennie Laura McIver Sharon Hems Bill Ramsay Samuel Oduro Vicky Cairns Corri Black Joy Nicholson Rupert Payne

42. Acknowledgements SMC Evaluation Reference and Management Groups SMC (User Group / PAPIG) SMC (Economic / Admin / Exec Team) ADTCs and clinical networks ABPI Information Services Division staff, NSS ScotCen / Scott Hill Sue Hewitt NHS QIS Comms team