The cost effectiveness of Apligraf® treatment of diabetic foot ulcers
The cost effectiveness of Apligraf® treatment of diabetic foot ulcers
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DOI：
10.2165/00019053-200321160-00003
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发表时间：
2003-01-01
影响因子：
4.4
通讯作者：
Kalo, Z
中科院分区：
文献类型：
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作者：
Redekop, WK;McDonnell, J;Kalo, Z
背景资料：糖尿病足溃疡（DFU）提出了治疗挑战，并导致巨大的经济负担，需要仔细评估新治疗方式的临床疗效和成本效益。生物工程皮肤替代物Aplidine（R）（Novartis Pharma AG，巴塞尔，瑞士）的DFU临床试验已经证明与单独的良好伤口护理（GWC）相比改善的临床功效。目的：确定Aplidine（R）加GWC与单独的GWC相比在治疗DFU中的经济影响和成本效益。研究视角：Societal.Methods:建立了一个基于马尔可夫的模拟模型，在12个月的时间内比较Aplibrium（R）加GWC与单独GWC的成本和效果。主要健康状态为“未感染溃疡”、“感染溃疡”、“坏疽”和“愈合溃疡”。转移概率基于临床试验结果，而成本估计基于荷兰的资源利用估计。的成本效益的结果措施是每溃疡的增量成本每月获得和每截肢avoided.Results的增量成本：在治疗的第一年的成本E4656 Aplialine（R）加GWC和E5310 GWC单独（1999年的值）。用Aplibrium（R）治疗导致成本降低，因为其更高的有效性抵消了产品的额外成本。这一效益在5个月后实现，这是两条成本曲线的交叉点。使用阿必利汀（R）使无溃疡时间增加了1.53个月（7.78 vs 6.25），并降低了截肢风险（6.3% vs 17.1%）。敏感性分析表明，成本参数（如单位的Apliferase（R）所需的，治疗实践的成本）和健康状态之间的转换概率影响的成本results.Conclusions：治疗Apliferase（R）加GWC导致在第一年的治疗费用比GWC单独减少了12%。无溃疡时间的增加加上截肢风险的降低在很大程度上抵消了产品的初始成本。
Background: Diabetic foot ulcers (DFUs) present a treatment challenge and result in a large economic burden, requiring careful evaluation of the clinical efficacy and cost effectiveness of new treatment modalities. DFU clinical trials of the bio-engineered skin substitute Apligraf(R) (Novartis Pharma AG, Basel, Switzerland) have demonstrated improved clinical efficacy compared with good wound care (GWC) alone.Objective: To determine the economic impact and cost effectiveness of Apligraf(R) plus GWC compared with GWC alone in the treatment of DFUs. Study perspective: Societal.Methods: A Markov-based simulation model was created to compare the costs and effects of Apligraf(R) plus GWC to those of GWC alone over a 12-month period. The primary health states were 'uninfected ulcer', 'infected ulcer', 'gangrene', and 'healed ulcer'. Transition probabilities were based on clinical trial results, while cost estimates were based on estimates of resource utilisation in the Netherlands. The cost-effectiveness outcome measures were the incremental cost per ulcer-free month gained and the incremental cost per amputation avoided.Results: Costs in the first year of treatment were E4656 for Apligraf(R) plus GWC and E5310 for GWC alone (1999 values). Treatment with Apligraf(R) led to lower costs since its greater effectiveness offset the added cost of the product. This benefit was realised after 5 months, the crossover point of the two cost curves. Apiligraf(R) use increased the amount of ulcer-free time by by 1.53 months (7.78 vs 6.25) and reduced the risk of amputation (6.3% vs 17.1%). Sensitivity analyses showed that cost parameters (e.g. units of Apligraf(R) required, cost of treatment practice) and transition probabilities between health states affected the cost results.Conclusions: Treatment with Apligraf(R) plus GWC resulted in a 12% reduction in costs over the first year of treatment compared with GWC alone. The increased ulcer-free time coupled with a reduced risk of amputation to a large extent offset the initial costs of the product.