Hernandez-Pastor Luis Javier, Ortega Ana, Garcia-Layana Alfredo, Giraldez Joaquin
Department of Pharmacy, Clínica Universitaria, Universidad de Navarra, Pamplona, Spain.
Clin Ther. 2008 Dec;30(12):2436-51. doi: 10.1016/j.clinthera.2008.12.025.
This study compared the cost-effectiveness of ranibizumab with that of photodynamic therapy (PDT) in the treatment of predominantly classic choroidal neovascularization secondary to age-related macular degeneration (AMD) from the perspective of a third-party payer in a Spanish setting.
We constructed a Markov model with 5 states defined by visual acuity (VA) in the better-seeing eye (Snellen scale), as follows: VA >20/40, <or=20/40 to >20/80, </or20/80 to >20/200, <or=20/200 to >20/400, and <or=20/400. A death state was also included. We took transition probabilities, number of ranibizumab injections, and number of PDT treatments from the ANCHOR (Anti-Vascular Endothelial Growth Factor Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration) trial. Utilities were taken from a published study of patients' preferences. We used unit costs from our hospital and drug costs from a national database. Resource utilization was determined by an ophthalmologist according to current clinical practice. We performed univariate, threshold, and probabilistic sensitivity analyses. Incremental costs (2007 euro) and quality-adjusted life-years (QALYs), both discounted at a 3% annual rate, and incremental cost-effectiveness ratios (ICERs; euro/QALY) were determined for the 2-year and life-expectancy time horizons.
Treating patients with varying degrees of visual impairment with ranibizumab instead of PDT, with a 2-year time horizon, was found to be euro18,328 more costly and to confer 0.140 additional QALY (euro131,275/QALY). This ICER was reduced to euro39,398/ QALY for the longer life-expectancy time horizon. According to the probabilistic sensitivity analysis, PDT is the therapy of choice in all cases below the threshold of euro30,000/QALY for the 2-year time horizon. Ranibizumab was the optimal intervention in 26% of cases in the longer lifetime horizon. When the initial VA was <or=20/400, the ICER increased to euro255,477 over 2 years. When ranibizumab was administered on an as-needed basis, as in the PrONTO (Prospective Optical coherence tomography imaging of patients with Neovascular AMD Treated with intra-Ocular ranibizumab) trial, the ICERs were reduced to euro29,566/QALY and euro11,469/QALY in the 2-year and life-expectancy horizons, respectively.
Based on these results, ranibizumab was not cost-effective when administered on a monthly basis. When administered as needed, ranibizumab was cost-effective compared with PDT for the treatment of AMD.
本研究从西班牙第三方支付方的角度，比较了雷珠单抗与光动力疗法（PDT）治疗年龄相关性黄斑变性（AMD）继发的主要为典型脉络膜新生血管的成本效益。
我们构建了一个马尔可夫模型，根据较好眼的视力（Snellen视力表）将其分为5种状态，如下：视力>20/40、≤20/40至>20/80、≤20/80至>20/200、≤20/200至>20/400以及≤20/400。还纳入了死亡状态。我们从ANCHOR（抗血管内皮生长因子抗体治疗年龄相关性黄斑变性继发的主要为典型脉络膜新生血管）试验中获取转移概率、雷珠单抗注射次数和PDT治疗次数。效用值取自一项已发表的关于患者偏好的研究。我们使用了本院的单位成本和国家数据库中的药品成本。资源利用情况由眼科医生根据当前临床实践确定。我们进行了单因素、阈值和概率敏感性分析。确定了2年和预期寿命时间范围内的增量成本（2007欧元）和质量调整生命年（QALY），两者均按每年3%的贴现率贴现，并计算了增量成本效益比（ICER；欧元/QALY）。
以2年为时间范围，用雷珠单抗而非PDT治疗不同程度视力损害的患者，发现成本高出18328欧元，且多获得0.140个QALY（131275欧元/QALY）。对于更长的预期寿命时间范围，该ICER降至39398欧元/QALY。根据概率敏感性分析，在2年时间范围内，ICER低于30000欧元/QALY的所有情况下，PDT是首选治疗方法。在更长的寿命时间范围内，雷珠单抗在26%的病例中是最佳干预措施。当初始视力≤20/400时，2年内ICER增至255477欧元。如在PrONTO（眼内注射雷珠单抗治疗新生血管性AMD患者的前瞻性光学相干断层扫描成像）试验中那样按需使用雷珠单抗时，2年和预期寿命时间范围内的ICER分别降至29566欧元/QALY和11469欧元/QALY。
基于这些结果，每月给药时雷珠单抗不具有成本效益。按需给药时，雷珠单抗治疗AMD与PDT相比具有成本效益。
