Transcript Drug appraisal organisations: A comparison of SMC and NICE
Drug appraisal organisations: A comparison of SMC and NICE John Ford, University of Aberdeen Norman Waugh, Warwick Evidence Pawana Sharma, University of Aberdeen Mark Sculpher, University of York Andrew Walker, University of Glasgow Scottish Medicine Consortium (SMC) • Established in 2001 • All newly licensed medications • Main submission from manufacturer National Institute of Health and Clinical Excellence (NICE) • Only medications referred from Department of Health • Pre-2005 – Technology Assessment Reports (TAR) • Post-2005 – Single technology appraisal (STA) – Multiple technology appraisal (MTA) • Various controversies Our study • What is the difference in recommendations and timelines between NICE and SMC? • Has the introduction of the STA system led to speedier guidance? Methods • Drug specific approach • All medications until Aug 2010 included • Time – from marketing authorisation (MA) to guidance publication • Appraisal outcomes – As defined by SMC or NICE Drug demographics • 140 drugs included – 57 cancer related • 415 by SMC alone – 45 cancer related • 102 by NICE – 27 cancer related Recommendations Drugs appraised by NICE and SMC 11% 18% Same Outcome Different restiction Different outcome 71% Recommendations NICE Decisions 10% Recommended SMC Decisions Recommended 20% 39% 19% Restricted Restricted 71% 41% Not recommended Not recommended Reason for differences in recommendation • Occasionally NICE allows cost per QALY >£30,000 • Timings of appraisals may differ • Manufacturers’ submission may not be the same • Longer appraisals Timelines (all drugs) Time from Marketing Authorisation MA to MTA MA to STA MA to Total NICE MA to SMC 0 5 10 15 Time (mths) 20 25 30 Reasons for differences in timelines • Consultation – Number of stakeholders – Size differences – Legal challenge? • Transparency – Final report Timelines (cancer drugs) Time from Marketing Authorisation for Cancer Drugs MA to MTA MA to STA MA to NICE MA to SMC 0 5 10 15 Time (mths) 20 25 30 Reasons for differences in cancer drugs • Evidence base may be uncertain • Cost per QALY likely to be borderline Discussion • Trade-off between transparency, consultation and timeliness • How many drug appraisal bodies does the UK need? Conclusion • Small difference in recommendations between SMC and NICE • SMC is considerable speedier than NICE • STA system has led to speedier decisions, but not for cancer drugs • Increased time is probably due to consultation and transparency Any questions?