Neubauer A S, Holz F G, Schrader W, Back E I, Kühn T, Hirneiss C, Kampik A
Augenklinik der Ludwig-Maximilians-Universität, München.
Klin Monbl Augenheilkd. 2007 Sep;224(9):727-32. doi: 10.1055/s-2007-963470.
Ranibizumab (Lucentis) stabilizes or improves visual acuity in a high percentage of patients with age-related macular degeneration (AMD). As this therapy is associated with significant costs, the aim of this study was to provide a cost-utility analysis, which considers both costs and utility of a therapy with ranibizumab in an economic model.
The incremental utility for the patient was modelled based on visual acuity data of the MARINA and ANCHOR study. The utility data used assume that the better seeing eye is affected. The study groups used for comparison consisted of patients who only received best supportive care, e. g., low-vision aids. The baseline scenario of the model assumes 6 treatments per year over a 2 year time period - based on the assessment of an expert panel. Treatment costs were based on German pharmacy prices and recommendations for reimbursement of the intravitreal injections. In a univariate sensitivity analysis all important parameters were varied to assess the stability of the results.
The baseline scenario yields for predominantly classic lesions 16,882 euro/QALY (quality adjusted life year), for minimally classic CNV 24,766 euro/QALY and for occult CNV 26,170 euro/QALY. If a distribution of the CNV types with 18 - 25 - 57 % is assumed, the mean cost of therapy with ranibizumab amounts to 24,147 euro/QALY. Sensitivity analysis showed that all reasonable variations yielded results which are considered cost-effective (<or= 50.000 US $/QALY). This is especially true for high and low patient age, for groups with low (0.05 - 0.1) and high ( > 0.4) visual acuity, for a variation of costs per treatment of +/- 20 %, and a prolonged treatment duration of 3 years.
In the investigated szenario a therapy of neovascular AMD with ranibizumab is cost-effective for all angiographic subtypes as well as in the sensitivity analysis.
雷珠单抗(Lucentis)可使高比例的年龄相关性黄斑变性(AMD)患者的视力稳定或提高。由于该疗法成本高昂,本研究旨在进行成本效用分析,在经济模型中综合考虑雷珠单抗治疗的成本和效用。
基于MARINA和ANCHOR研究的视力数据对患者的增量效用进行建模。所使用的效用数据假设受影响的是视力较好的眼睛。用于比较的研究组包括仅接受最佳支持性护理(如低视力辅助器具)的患者。模型的基线情景假设基于专家小组的评估,在2年时间内每年进行6次治疗。治疗成本基于德国药房价格和玻璃体内注射的报销建议。在单因素敏感性分析中,对所有重要参数进行变化以评估结果的稳定性。
对于主要为典型病变,基线情景产生的成本效益为16,882欧元/质量调整生命年(QALY);对于最小典型性脉络膜新生血管(CNV)为24,766欧元/QALY,对于隐匿性CNV为26,170欧元/QALY。如果假设CNV类型的分布为18 - 25 - 57%,则雷珠单抗治疗的平均成本为24,147欧元/QALY。敏感性分析表明,所有合理的变化产生的结果都被认为具有成本效益(<或=50,000美元/QALY)。对于高年龄和低年龄患者、视力低(0.05 - 0.1)和高(>0.4)的组、每次治疗成本变化+/-20%以及治疗持续时间延长至3年的情况尤其如此。
在所研究的情景中,雷珠单抗治疗新生血管性AMD对于所有血管造影亚型以及在敏感性分析中都是具有成本效益的。