Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Via Sarfatti 10, 20136, Milan, Italy.
Smith & Nephew, Fort Worth, TX, USA.
Adv Ther. 2023 Dec;40(12):5271-5284. doi: 10.1007/s12325-023-02686-9. Epub 2023 Sep 28.
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.
肩袖撕裂（RCT）是一种由肩袖肌腱损伤引起的疼痛性、进行性疾病，是导致与肩部相关残疾的主要原因。肩袖撕裂的手术修复是一种既定的标准治疗方法（SOC）；然而，手术可能会失败。在这种情况下，使用基于胶原蛋白的生物诱导植入物 REGENETEN 显示出临床评分的长期改善。本研究旨在从意大利国家医疗保健服务（NHS）和社会两个角度评估 REGENETEN 联合 SOC（SOC+REGENETEN）与单独 SOC 相比的成本效益。
开发了一个决策分析模型，以估算两种考虑的治疗策略在 1 年内愈合的撕裂数量和成本。临床数据从文献中检索，患者管理的临床途径从意大利的四位主要意见领袖中检索。
在 1 年的时间内，使用和不使用 REGENETEN 修复 RCT 的愈合病变分别为 90.70%和 72.90%。从 NHS 的角度来看，两种策略的每位患者平均成本分别为 7828 欧元和 4650 欧元，导致每愈合一个撕裂的增量成本效益比（ICER）为 17857 欧元。从社会角度来看，SOC 的每位患者平均成本为 12659 欧元，REGENETEN 的每位患者平均成本为 11784 欧元，因此当使用生物诱导植入物时，每愈合一个撕裂可节省 4918 欧元。敏感性分析证实了模型结果的稳健性。
在缺乏成本效益研究的情况下，我们的研究结果为临床医生和支付者提供了关于新治疗选择的额外证据，该选择支持针对 RCT 患者的个体化治疗方法。
