Newcastle upon Tyne Hospitals National Health Service Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
Regional Medical Physics Department, NICE External Assessment Centre, Freeman Hospital, High Heaton, NE7 7DN, UK.
Appl Health Econ Health Policy. 2017 Aug;15(4):455-468. doi: 10.1007/s40258-016-0302-x.
The Spectra Optia automated apheresis system, indicated for red blood cell exchange in people with sickle cell disease, underwent evaluation by the National Institute for Health and Care Excellence, which uses its Medical Technologies Advisory Committee to make recommendations. The company (Terumo Medical Corporation) produced a submission making a case for adoption of its technology, which was critiqued by the Newcastle and York external assessment centre. Thirty retrospective observational studies were identified in their clinical submission. The external assessment centre considered these were of low methodological and reporting quality. Most were single-armed studies, with only six studies providing comparative data. The available data showed that, compared with manual red blood cell exchange, Spectra Optia reduces the frequency of exchange procedures as well as their duration, but increases the requirement for donor blood. However, other clinical and patient benefits were equivocal because of an absence of robust clinical evidence. The company provided a de novo model to support the economic proposition of the technology, and reported that in most scenarios Spectra Optia was cost saving, primarily through reduced requirement of chelation therapy to manage iron overload. The external assessment centre considered that although the cost-saving potential of Spectra Optia was plausible, the model and its clinical inputs were not sufficiently robust to demonstrate this. However, taking the evidence together with expert and patient advice, the Medical Technologies Advisory Committee considered Spectra Optia was likely to save costs, provide important patient benefits, and reduce inequality, and gave the technology a positive recommendation in Medical Technology Guidance 28.
Spectra Optia 自动化血浆分离系统被指示用于镰状细胞病患者的红细胞置换，接受了国家卫生与保健卓越研究所的评估，该研究所利用其医疗技术咨询委员会提出建议。该公司（泰尔茂医疗株式会社）提交了一份采用其技术的申请，纽卡斯尔和约克外部评估中心对该申请进行了批评。在其临床申请中确定了 30 项回顾性观察性研究。外部评估中心认为这些研究在方法学和报告质量方面都较低。大多数是单臂研究，只有 6 项研究提供了比较数据。可用数据表明，与手动红细胞置换相比，Spectra Optia 减少了交换程序的频率及其持续时间，但增加了对供体血液的需求。然而，由于缺乏可靠的临床证据，其他临床和患者益处仍存在争议。该公司提供了一个新模型来支持该技术的经济主张，并报告说，在大多数情况下，Spectra Optia 具有成本效益，主要是通过减少铁超负荷管理所需的螯合疗法。外部评估中心认为，尽管 Spectra Optia 的成本节约潜力是合理的，但该模型及其临床投入不够稳健，无法证明这一点。然而，综合考虑证据以及专家和患者的建议，医疗技术咨询委员会认为 Spectra Optia 可能会节省成本，提供重要的患者益处，并减少不平等，并在医疗技术指南 28 中对该技术给予了积极建议。
