Health Economics Research Group, Brunel University, Uxbridge, Middlesex, UB8 3PH, UK.
Pharmacoeconomics. 2013 Feb;31(2):137-49. doi: 10.1007/s40273-012-0013-6.
There is growing interest internationally in linking reimbursement decisions with recommendations for further research. In the UK, the National Institute for Health and Clinical Excellence (NICE) can issue guidance to approve the routine use of a health intervention, reject routine use or recommend use within a research programme. These latter recommendations have restricted use to 'only in research' (OIR) or have recommended further research alongside routine use ('approval with research' or AWR). However, it is not currently clear when such recommendations are likely to be made.
This study aims to identify NICE technology appraisals where OIR or AWR recommendations were made and to examine the key considerations that led to those decisions.
Draft and final guidance including OIR/AWR recommendations were identified. The documents were reviewed to establish the characteristics of the technology appraisal, the cost effectiveness of the technologies, the key considerations that led to the recommendations and the types of research required.
In total, 29 final and 31 draft guidance documents included OIR/AWR recommendations up to January 2010. Overall, 86 % of final guidance included OIR recommendations. Of these, the majority were for technologies considered to be cost ineffective (83 %) and the majority of final guidance (66 %) specified the need for further evidence on relative effectiveness. The use of OIR/AWR recommendations is decreasing over time and they have rarely been used in appraisals conducted through the single technology appraisal process.
NICE has used its ability to recommend technologies within research programmes, although predominantly within the multiple technology appraisal process. OIR recommendations have been most frequently issued for technologies considered cost ineffective and the most frequently cited consideration is uncertainty related to relative effectiveness. Key considerations cited for most AWR recommendations and some OIR recommendations included a need for further evidence on long-term outcomes and adverse effects of treatment.
国际上越来越关注将报销决策与进一步研究的建议联系起来。在英国，国家卫生与临床优化研究所（NICE）可以发布指导意见，批准将健康干预措施常规使用、拒绝常规使用或建议在研究计划中使用。后一类建议将使用限制为“仅在研究中”（OIR），或建议在常规使用的同时进行进一步研究（“批准与研究”或 AWR）。然而，目前尚不清楚何时可能会做出这些建议。
本研究旨在确定 NICE 技术评估中提出 OIR 或 AWR 建议的情况，并检查导致这些决定的关键考虑因素。
确定了草案和最终指导意见，包括 OIR/AWR 建议。审查文件以确定技术评估的特征、技术的成本效益、导致建议的关键考虑因素以及所需的研究类型。
截至 2010 年 1 月，共有 29 份最终指导意见和 31 份草案指导意见中包含 OIR/AWR 建议。总体而言，86%的最终指导意见包含 OIR 建议。其中，大多数是针对被认为成本效益不佳的技术（83%），大多数最终指导意见（66%）都规定需要进一步提供相对有效性的证据。随着时间的推移，OIR/AWR 建议的使用呈下降趋势，并且在通过单一技术评估程序进行的评估中很少使用。
NICE 已经利用其在研究计划中推荐技术的能力，尽管主要是在多技术评估过程中。OIR 建议最常针对被认为成本效益不佳的技术提出，最常引用的考虑因素是与相对有效性相关的不确定性。大多数 AWR 建议和一些 OIR 建议引用的关键考虑因素包括需要进一步提供关于长期结果和治疗副作用的证据。
