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.
Comparative study of drug appraisals published by NICE and SMC.
NICE and SMC.
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.
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).
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.
Has the STA process resulted in speedier guidance for NICE?
What are the differences in recommendation and timelines between SMC and NICE?
The STA system has resulted in speedier guidance for some drugs but not for cancer drugs.
SMC publishes speedier guidance than NICE.
SMC and NICE recommend a similar proportion of drugs.
Strength and limitations of this study
Although some differences by SMC and NICE are shown, it is not possible in this study to say which is correct.
Accuracy of outcome data taken from NICE website and SMC annual reports is unclear.