背景:肩袖撕裂(RCT)是一种痛苦的,由肩袖肌腱损伤引起的进行性疾病,是导致肩关节相关残疾的主要原因。肩袖的手术修复是既定的护理标准(SOC);然而,程序可能会失败。在这种情况下,使用基于胶原的生物诱导植入物REGENETEN显示临床评分的长期改善.该研究的目的是从国家医疗保健服务(NHS)和意大利的社会角度评估REGENETEN与SOC(SOCREGENETEN)结合使用的成本效益。
方法:开发了一个决策分析模型来估计两种治疗策略在1年内治愈的泪液数量和成本。从文献中检索临床数据,我们从意大利的4位主要意见领袖那里检索了RCT患者的临床路径.
结果:在1年的时间范围内,有和没有REGENETEN的RCT手术修复的愈合性病变分别为90.70%和72.90%,分别。考虑到NHS的观点,两种策略的每位患者平均费用为7828欧元和4650欧元,分别,导致每个愈合的泪液的成本效益比(ICER)增加17,857欧元。从社会的角度来看,每位患者的平均费用为SOC12,659欧元,REGENETEN为11,784欧元,因此,当使用生物诱导植入物时,每个愈合的眼泪节省4918欧元。敏感性分析证实了模型结果的稳健性。
结论:在缺乏成本效益研究的背景下,我们的研究结果为临床医师和支付者提供了更多的证据,证明新的治疗方案的价值,该方案支持针对RCT患者的量身定制管理方法.
肩袖是指一组四块肌肉,肌腱连接到上臂骨,它们共同作用以允许提升和旋转肩部。肩袖撕裂可影响单个肌腱或多个肌腱。典型的一线治疗包括保守治疗,旨在减轻疼痛和减少功能障碍,但往往是无效的。持续性疾病通常通过常规手术修复来管理。最近,REGENETEN,基于胶原蛋白的生物诱导植入物,源自纯化的牛跟腱,位于受损的肩袖部位,成功完成肩袖肌腱修复,与传统手术相比,1年时愈合的泪液增加17.80%.考虑到意大利国家医疗服务的观点,与传统手术相比,使用REGENETEN额外治愈泪液所需的费用为17,857欧元.从社会的角度来看,其中包括患者从入院到重返工作岗位的生产力损失,与传统手术相比,使用REGENETEN可以节省成本.我们的研究结果为临床医生和付款人提供了证据,以支持肩袖病变患者的新治疗选择的价值。
Rotator cuff tear (RCT) is a painful, progressive condition resulting from damage to the rotator cuff tendons and is the leading cause of shoulder-related disability. Surgical repair of rotator cuff is an established standard of care (SOC); however, failure of the procedure can occur. In this context, the use of collagen-based bioinductive implant REGENETEN showed long-term improvements in clinical scores. The aim of the study was to assess the cost-effectiveness of REGENETEN combined with SOC (SOC + REGENETEN) compared to SOC alone from both National Healthcare Service (NHS) and societal perspectives in Italy.
A decision analytic model was developed to estimate the number of tears healed and costs for the two considered treatment strategies over 1 year. Clinical data were retrieved from the literature, and the clinical pathways for the management of patients with RCTs were retrieved from four key opinion leaders in Italy.
Over a 1-year time horizon, healed lesions were 90.70% and 72.90% for surgical repair of RCTs with and without REGENETEN, respectively. Considering the NHS perspective, mean costs per patient were €7828 and €4650 for the two strategies, respectively, leading to an incremental cost-effectiveness ratio (ICER) of €17,857 per healed tear. From the societal perspective, the mean costs per patient were €12,659 for SOC and €11,784 for REGENETEN, thus showing savings of €4918 per healed tear when the bioinductive implant is used. The sensitivity analyses confirmed the robustness of the model results.
In the context of paucity of cost-effectiveness studies, our findings provide additional evidence for clinicians and payers regarding the value of a new treatment option that supports a tailored approach for the management of patients with RCTs.
The rotator cuff refers to a group of four muscles, with tendons connected to the upper arm bone, which act together to allow lifting and rotating the shoulder. A tear of the rotator cuff can affect either a single tendon or multiple tendons. Typical first-line treatment includes conservative therapies, which aim to alleviate pain and reduce functional impairment, but are often ineffective. Persisting disease is usually managed through conventional surgical repair. Recently, REGENETEN, a collagen-based bioinductive implant derived from purified bovine Achilles tendon, positioned over the site of the damaged rotator cuff, achieved successful rotator cuff tendon repair with an increase in healed tears of 17.80% at 1 year compared to conventional surgery. Considering the National Healthcare Service perspective in Italy, the cost needed to achieve one additional healed tear using REGENETEN compared to conventional surgery is €17,857. From the societal perspective, which includes patients’ productivity losses from hospital admission to return to work, the use of REGENETEN may be cost-saving compared to conventional surgery. The findings of our study provide evidence for clinicians and payers to support the value of a new treatment option for patients with rotator cuff lesions.