Drug appraisal organisations: A comparison of SMC and NICE

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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?