Objectives To compare the timelines and recommendations of the Scottish Medicines Consortium (SMC) and National Institute of Health and Clinical Excellence (NICE), in particular since the single technology assessment (STA) process was introduced in 2005.
Design Comparative study of drug appraisals published by NICE and SMC.
Setting NICE and SMC.
Participants All drugs appraised by SMC and NICE, from establishment of each organisation until August 2010, were included. Data were gathered from published reports on the NICE website, SMC annual reports and European Medicines Agency website.
Primary and secondary outcome measures Primary outcome was time from marketing authorisation until publication of first guidance. The final outcome for each drug was documented. Drug appraisals by NICE (before and after the introduction of the STA process) and SMC were compared.
Results NICE and SMC appraised 140 drugs, 415 were appraised by SMC alone and 102 by NICE alone. NICE recommended, with or without restriction, 90% of drugs and SMC 80%. SMC published guidance more quickly than NICE (median 7.4 compared with 21.4 months). Overall, the STA process reduced the average time to publication compared with multiple technology assessments (median 16.1 compared with 22.8 months). However, for cancer medications, the STA process took longer than multiple technology assessment (25.2 compared with 20.0 months).
Conclusions Proportions of drugs recommended for NHS use by SMC and NICE are similar. SMC publishes guidance more quickly than NICE. The STA process has improved the time to publication but not for cancer drugs. The lengthier time for NICE guidance is partly due to measures to provide transparency and the widespread consultation during the NICE process.
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To cite: Ford J, Waugh N, Sharma P, et al. NICE guidance: a comparative study of the introduction of the single technology appraisal process and comparison with guidance from Scottish Medicines Consortium. BMJ Open 2012;2:e000671. doi:10.1136/bmjopen-2011-000671
Funding No external funding.
Competing interests None.
Contributors JF carried out most of the data extraction and analysis, produced the first draft and is the guarantor. PS carried out some initial analysis and contributed to design of the analysis. NW analysed reasons for the different recommendations in table 3, using published guidances. AW and MS, with considerable experience of SMC and NICE processes, respectively, commented on drafts. MS is a former member of the NICE Technology Appraisal Committee and is also a member of one of the academic groups, which provide assessment reports (for MTAs) or evidence reviews (for STAs). NW was a member of the NICE AC for 5 years and has been a member of three assessment/evidence review groups. All authors commented on the final draft.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No data are available.
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