Barham Leela
Independent Consultant, London, UK.
Pharmacoeconomics. 2008;26(12):1037-43. doi: 10.2165/0019053-200826120-00006.
In 2005, a new technology appraisal process (the Single Technology Appraisal [STA]) was implemented by the National Institute for Health and Clinical Excellence (NICE), an independent agency that provides guidance to the UK NHS on the use of technology. The objective of STAs was to provide faster guidance to the NHS in order to help overcome the problems of 'NICE blight'.
Publicly available data from the NICE website and date of first marketing authorization (MA) from the Electronic Medicines Compendium were used to determine if STAs for cancer technologies have in fact been able to provide faster guidance than multiple technology appraisals (MTAs) for cancer interventions.
STAs in cancer have, on average, taken 12.8 months from the date that NICE lists in the project history to guidance date. This compares with 20.7 months for MTAs in cancer. However, the time between the date of first MA and guidance is longer for cancer-related STAs than MTAs (95.1 months vs 74.6 months). The reasons for this are not clear; however, the STA programme includes examples of using an older product to treat a new cancer site, which may account for some of the differential. It may also reflect the timing that products are referred to NICE.
The overall results suggest that STAs may be faster once NICE looks at the specific product, but that there is a greater delay in the referral of STA products to NICE than for MTA products. However, the time taken for STAs is still short of the target of 9.75 months (or 39 weeks) [assuming no appeals].
2005年,英国国家卫生与临床优化研究所(NICE)实施了一项新技术评估程序(单一技术评估[STA]),该研究所是一家为英国国民健康服务体系(NHS)提供技术使用指导的独立机构。STA的目标是为NHS提供更快的指导,以帮助克服“NICE困境”问题。
使用NICE网站上公开的数据以及电子药品手册中的首次上市许可(MA)日期,来确定癌症技术的STA是否实际上能够比癌症干预措施的多项技术评估(MTA)提供更快的指导。
癌症相关的STA从NICE在项目历史中列出之日到发布指导意见的平均时间为12.8个月。相比之下,癌症相关的MTA平均时间为20.7个月。然而,与癌症相关的STA从首次MA日期到发布指导意见的时间比MTA更长(95.1个月对74.6个月)。原因尚不清楚;不过,STA项目包括使用旧产品治疗新癌症部位的例子,这可能是造成部分差异的原因。这也可能反映了产品提交给NICE的时间。
总体结果表明,一旦NICE关注特定产品,STA可能会更快,但STA产品提交给NICE的时间比MTA产品有更大延迟。然而,STA所花费的时间仍未达到9.75个月(或39周)的目标[假设无上诉情况]。