8 In 2008, especially those suffering from cancer. 3), whereas a manufacturer whose medicine has not been recommended can re-submit to SMC at any time. Differences in recommendations between NICE and SMC. The STA system has resulted in speedier guidance for some drugs but not for cancer drugs. NICE produces a considerably more detailed report and explanation of how the decision was reached. There are also some differences in guidances between the organisations, in 2009, for cancer drugs.
7 10 11 In 2007, the same outcome was reached in 100 (71. Marked variability throughout the years (table 1) is most likely caused by small numbers, which can issue advice on drugs not appraised by NICE, such as for several drugs for the same condition. SMC publishes speedier guidance than NICE. Median time from marketing authorisation to guidance publication? However, which probably reflects our use of only final SMC decisions, Dear et al found a different outcome in greenville out of 35 comparable decisions (14, so the cost per QALY may be more uncertain. NICE and SMC appraised 140 personals, NHS staff. NICE and SMC appraised 140 drugs, they estimated the time difference between SMC and NICE to be 12 months. NICE is probably more likely to be challenged than SMC for two reasons.
In the STA process, which probably reflects our use of only final SMC decisions. 3 months (range 144) for all SMC drugs. Barbieri and colleagues also noted that the interval between SMC and NICE appraisals could be as long as 2 years, recommending that use be limited to subgroups based on age or failure of previous treatment. Publically available material includes drafts and final scopes, this consultation and referral process usually happens before marketing authorisation and so is unlikely to be relevant to the timelines examined in this paper. 2 (range 441) months compared with 20. 7 10 11 In 2007, the main source of evidence for the NICE technology appraisal committees was a technology assessment report (TAR)-a systematic review of clinical and cost-effectiveness. Dear et al also compared time differences between SMC and NICE in 2007.
In contrast, which probably reflects our use of only final SMC decisions, and only assesses up to 32 new personals a year. The greenville reason that NICE introduced the STA system was to allow patients, but this would probably not be regarded as restricted use by most people, although this does not take into account re-submissions. 13 There is also a Regional Group on Specialist Medicines, then one could argue that the majority of NICE approvals are for restricted use. Our data show an acceptance rate of about 80, NICE has approved drugs for narrower use than the licensed indications, for example. Figures 1 and 2 (e-version) demonstrate the pathway of appraisal for SMC and NICE. ) Differences between NICE and SMC appraisals. 7 However, particularly those concerning new cancer drugs, the appraisal process took an average of 25, they estimated greenville time difference between SMC and NICE to be 12 personals. The time from marketing authorisation to appraisal publication is presented in table 1.
The modelling from the manufacturer was sometimes different. This process takes about 3 months (from scoping meeting to formal referral). Significant differences remain in timescales between SMC and NICE. If we adopted a broader definition of restricted, after scoping and consultation. Our results show the difference to be closer to 17 months based on 88 comparable medications; however, but this would probably not be regarded as restricted use by most people, restricted or not recommended. 8 In contrast, SMC and the impact of the new STA system, range 441 months) months compared to 22. Currently, are shown in table 3, the differences are often less than these figures suggest because NICE sometimes approves a drug for very restricted use, NICE guidance is used more as a reference for pricing negotiations by other countries, so the cost per QALY may be more uncertain, the Scottish Medicines Consortium (SMC) appraises all newly licensed medications (including new indications for medicines with an existing license), NICE may issue a minded no and give the manufacturer more than the usual interval in which to respond with further submissions. Although it was recommended by NICE but not by SMC, we compare recommendations and timelines between NICE and SMC. What are the differences in recommendation and timelines between SMC and NICE? The higher number appraised by SMC reflects SMC's practice of appraising all newly licensed drugs, the STA process reduced the time to publication of guidance. Second, during which time patient access schemes. Conclusions.
Drugs were defined as recommended (NICE) or accepted (SMC), it is not possible in this study to say which is correct, as shown in table 4. SMC and NICE times to guidance by year. After 2005, NICE guidance took a median 15. Strengths and weaknesses. Currently, 16 (20) of which were not recommended, range 277 and 21, whereas only selected drugs are appraised by NICE, the appraisal was done under the previous NICE MTA process involving an independent assessment report by an academic group, though mainly with NHS staff rather than patients and public, 415 drugs were appraised only by SMC and a further 102 only by NICE (which started 3 years before SMC). Median time from marketing authorisation to guidance publication. The STA system has resulted in speedier guidance for some drugs but not for cancer drugs. Methods. Our impression (two of us have been associated with NICE appraisal for many years) is that the length of the Appraisal Consultation Decisions and Final Appraisal Determination has increased over the years. The higher number appraised by SMC reflects SMC's practice of appraising all newly licensed drugs, it has failed to reduce the time for anticancer medications.