Bruyère Olivier, Reginster Jean-Yves
Research Unit in Public Health, Epidemiology and Health Economics, University of Liège, CHU of Liege, Bât B23, 4000, Liège, Belgium.
Department of Physical Activity and Rehabilitation Sciences, University of Liège, Liège, Belgium.
Adv Ther. 2025 Jan;42(1):165-173. doi: 10.1007/s12325-024-03007-4. Epub 2024 Oct 30.
In a previously published randomised, placebo-controlled trial, 800 mg/day of pharmaceutical-grade chondroitin sulfate (CS) was shown to be superior to placebo in reducing pain and improving function over 6 months in patients with symptomatic knee osteoarthritis (OA). The aim of the current post hoc analyses was to evaluate the cost-effectiveness of CS compared with placebo in a European perspective using individual patient data from this clinical trial.
Patients with knee OA randomised to CS or placebo were followed up at 1, 3 and 6 months. The algo-functional Lequesne index was used to derive the EuroQol Five-Dimension Five-Level (EQ-5D-5L) score based on a validated formula. The EQ-5D-5L scores at each time point were used to calculate the changes in quality-adjusted life years (QALYs) with the area under the curve method. Costs were assessed using the average price of CS in the countries where the original study took place and where CS is currently marketed. The costs of CS in three countries were then used (i.e. the Czech Republic, Italy and Switzerland). The incremental cost-effectiveness ratio (ICER) threshold for CS to be considered cost-effective was set at 91,870 EUR per QALY (equivalent to the usually recommended threshold of US $100,000). The study used an intention-to-treat population, i.e. patients who received one dose of the study drug, and imputed missing values using the basal observation carried forward method.
No significant differences in baseline characteristics were observed between the CS group (N = 199) and the placebo group (N = 205). The mean cost of CS for 6 months of treatment was 194.74 EUR. After 6 months of treatment, CS showed a mean ICER of 33,462 (95% CI 5130-61,794) EUR per QALY gained, indicating cost-effectiveness compared with placebo. The acceptability curve for cost-effectiveness shows that the CS treatment is likely to be cost-effective compared with placebo, with a 93% probability when the ceiling ratio is set at 91,870 EUR per QALY gained.
These results highlight the role of CS as a cost-effective therapeutic option in the management of OA. However, further studies taking into account the use of other healthcare resources are warranted for a more complete understanding.
在之前发表的一项随机、安慰剂对照试验中，对于有症状的膝关节骨关节炎（OA）患者，每天800毫克药用级硫酸软骨素（CS）在6个月内减轻疼痛和改善功能方面优于安慰剂。当前这项事后分析的目的是，利用该临床试验的个体患者数据，从欧洲视角评估CS与安慰剂相比的成本效益。
将随机分配至CS组或安慰剂组的膝关节OA患者在1、3和6个月时进行随访。使用算法功能Lequesne指数，根据一个经过验证的公式得出欧洲五维度五水平健康量表（EQ-5D-5L）评分。每个时间点的EQ-5D-5L评分用于通过曲线下面积法计算质量调整生命年（QALY）的变化。使用原研究开展国家以及CS目前销售国家中CS的平均价格评估成本。然后采用三个国家（即捷克共和国、意大利和瑞士）CS的成本。将CS被认为具有成本效益的增量成本效益比（ICER）阈值设定为每QALY 91,870欧元（相当于通常推荐的100,000美元阈值）。该研究采用意向性治疗人群，即接受一剂研究药物的患者，并使用基线观察值结转法估算缺失值。
CS组（N = 199）和安慰剂组（N = 205）之间在基线特征方面未观察到显著差异。6个月治疗期CS的平均成本为194.74欧元。治疗6个月后，CS每获得一个QALY的平均ICER为33,462（95%CI 5130 - 61,794）欧元，表明与安慰剂相比具有成本效益。成本效益的可接受性曲线显示，与安慰剂相比，CS治疗可能具有成本效益，当每获得一个QALY的上限比设定为91,870欧元时，概率为93%。
这些结果突出了CS作为OA管理中具有成本效益的治疗选择的作用。然而，为了更全面地理解，有必要开展进一步研究，考虑使用其他医疗资源的情况。
