Giorgio Calori Maria, Capanna Rodolfo, Colombo Massimiliano, De Biase Pietro, O'Sullivan Carol, Cartareggia Valentina, Conti Costanza
Orthopaedic Reparative Surgery Department, G. Pini Institute, University of Milan, Milan, Italy.
Injury. 2013 Dec;44(12):1871-9. doi: 10.1016/j.injury.2013.08.012. Epub 2013 Aug 30.
Current evidences show that recombinant human bone morphogenetic protein 7 (rhBMP-7, eptotermin alfa) can be considered an effective alternative to autologous bone graft (ABG) in the treatment of tibial nonunions. Few studies, so far, have analysed the costs of treating tibial nonunions with either rhBMP-7 or ABG and none of them has specifically considered the Italian situation. The aim of the present study was to capture, through observational retrospective methods, the direct medical costs associated with the treatment of tibial nonunions with rhBMP-7 or ABG in Italy and to compare the cost effectiveness of the two interventions. The secondary objective was to perform a cost-reimbursement analysis for hospitalisations associated with the two treatments. Data of 54 patients with indication for tibial nonunion were collected from existing data sources. Of these patients, 26 were treated with ABG and 28 with rhBMP-7. The study captured the direct medical costs for treating each tibial nonunion, considering both inpatient and outpatient care. The hospital reimbursement was calculated from discharge registries, based on diagnosis-related group (DRG) values. A subgroup of patients (n=30) was also interviewed to capture perceived health during the follow-up, and the quality-adjusted life years (QALYs) were subsequently computed. The two groups were similar for what concerns baseline characteristics. While the medical costs incurred during the hospitalisation associated with treatment were on average €3091.21 higher (P<0.001) in patients treated with rhBMP-7 (reflecting the product procurement costs), the costs incurred during the follow-up were on average €2344.45 higher (P=0.02) in patients treated with ABG. Considering all costs incurred from the treatment, there was a borderline statistical evidence (P=0.04) for a mean increase of €795.42, in the rhBMP-7 group. Furthermore, the study demonstrated that, without appropriate reimbursement, the hospital undergoes significant losses (P=0.003) when using rhBMP-7 instead of ABG. In contrast to these losses, in Italy, the average cost to achieve a successful outcome was €488.96 lower in patients treated with rhBMP-7 and, additionally, the cost per QALY gained was below the cost-utility threshold of $50,000.
目前的证据表明，重组人骨形态发生蛋白7（rhBMP - 7，依普黄酮）在治疗胫骨骨不连方面可被视为自体骨移植（ABG）的有效替代方法。到目前为止，很少有研究分析用rhBMP - 7或ABG治疗胫骨骨不连的成本，而且没有一项研究专门考虑意大利的情况。本研究的目的是通过观察性回顾性方法，获取意大利用rhBMP - 7或ABG治疗胫骨骨不连的直接医疗成本，并比较这两种干预措施的成本效益。次要目标是对与这两种治疗相关的住院费用进行成本报销分析。从现有数据源收集了54例有胫骨骨不连指征患者的数据。其中，26例接受了ABG治疗，28例接受了rhBMP - 7治疗。该研究考虑了住院和门诊护理，获取了治疗每例胫骨骨不连的直接医疗成本。医院报销是根据出院登记，基于诊断相关分组（DRG）值计算的。还对一组患者（n = 30）进行了访谈，以了解随访期间的感知健康状况，随后计算了质量调整生命年（QALY）。两组在基线特征方面相似。虽然接受rhBMP - 7治疗的患者与治疗相关的住院期间产生的医疗成本平均高出3091.21欧元（P < 0.001）（反映了产品采购成本），但接受ABG治疗的患者随访期间产生的成本平均高出2344.45欧元（P = 0.02）。考虑到治疗产生的所有成本，rhBMP - 7组平均增加795.42欧元有临界统计学证据（P = 0.04）。此外，研究表明，在没有适当报销的情况下，医院使用rhBMP - 7而非ABG时会遭受重大损失（P = 0.003）。与这些损失形成对比的是，在意大利，接受rhBMP - 7治疗的患者实现成功结果的平均成本低488.96欧元，此外，每获得一个QALY的成本低于50,000美元的成本效用阈值。
