Center for the Evaluation of Value and Risk in Health, Tufts Medical Center, 35 Kneeland St., Boston, MA, 02111, USA.
Appl Health Econ Health Policy. 2022 Mar;20(2):235-241. doi: 10.1007/s40258-021-00698-6. Epub 2021 Nov 25.
Medical devices can offer important therapeutic advances but, as for any medical interventions, there are questions about their costs and benefits. We examined health benefits and costs for pre-market approved (PMA) devices approved by the US Food and Drug Administration (FDA) (1999-2015), grouping them by generic category (e.g., drug-eluting stents) and indication.
We searched PubMed for incremental health gain estimates [measured in quality-adjusted life-years (QALYs)] and incremental costs for each device category compared to previously available treatments. We calculated incremental cost-effectiveness ratios by dividing the average incremental costs by the average incremental QALY gains. In sensitivity analysis, we repeated the analysis when excluding industry-funded studies.
We identified at least one relevant cost-utility or comparative-effectiveness study for 88 devices (15.9% of non-cosmetic devices approved from 1999 to 2015), and at least one device across 53 (26.2%) generic categories. The median (mean) incremental cost across generic device categories was $1701 ($13,320). The median (mean) incremental health gain across generic device categories was 0.13 (0.46) QALYs. We found that cost-effectiveness ratios for 36 of 53 (68%) and 43 of 53 (81%) device categories fell below (were more favorable than) $50,000 and $150,000 per QALY, respectively. Results were roughly similar when we excluded industry-funded studies.
We found that roughly one-quarter of the major PMA medical device categories have published cost-effectiveness evidence accessible through a large, publicly available database. Available evidence suggests that devices generally offer good value, as judged relative to established cost-effectiveness benchmarks.
医疗器械可以提供重要的治疗进展，但与任何医疗干预一样，人们对其成本和效益存在疑问。我们研究了美国食品和药物管理局（FDA）批准的上市前批准（PMA）设备（1999-2015 年）的健康效益和成本，按通用类别（例如，药物洗脱支架）和适应症对其进行分组。
我们在 PubMed 上搜索了每个设备类别与先前可用治疗方法相比的增量健康收益估计值（以质量调整生命年（QALY）衡量）和增量成本。我们通过将平均增量成本除以平均增量 QALY 收益来计算增量成本效益比。在敏感性分析中，我们在排除行业资助研究的情况下重复了分析。
我们确定了 88 种设备（1999 年至 2015 年批准的非整容设备的 15.9%）至少有一种相关的成本效益或比较效益研究，以及至少有一种设备跨越了 53 种（26.2%）通用类别。通用设备类别中增量成本的中位数（平均值）为 1701 美元（13320 美元）。通用设备类别中增量健康收益的中位数（平均值）为 0.13（0.46）QALY。我们发现，53 个设备类别中的 36 个（68%）和 53 个设备类别中的 43 个（81%）的成本效益比低于（优于）分别为 50000 美元和 150000 美元/QALY。当我们排除行业资助的研究时，结果大致相似。
我们发现，大约四分之一的主要 PMA 医疗器械类别具有通过大型公共可用数据库可获得的已发表的成本效益证据。现有证据表明，相对于既定的成本效益基准，设备通常具有良好的价值。
