IMS Consulting Group, Milan, Italy.
Appl Health Econ Health Policy. 2012 Mar 1;10(2):127-38. doi: 10.2165/11597980-000000000-00000.
A probabilistic patient-level Markov model was previously developed to simulate lifetime clinical and economic outcomes of cinacalcet treatment in secondary hyperparathyroidism (SHPT) patients using local data from Italy. The present study extends the application of the model to four other European countries - Spain, Portugal, Switzerland and the Czech Republic - in order to assess the consistency of results.
Cinacalcet influences the levels of parathyroid hormone, serum calcium and phosphorous. Our simulation was based on data from the OPTIMA (Open-Label, Randomized Study Using Cinacalcet to Improve Achievement of KDOQI Targets in Patients with End-Stage Renal Disease) randomized controlled trial and from published correlations between bone-metabolism parameters, mortality and morbidity (cardiovascular [CV] events, fractures and parathyroidectomy). Local epidemiological and cost data for dialysis, drugs and event management were incorporated into the model. The simulation horizon was patient lifetime; standard treatment for SHPT (vitamin D sterols and phosphate binders) and cinacalcet plus standard treatment were compared. Effectiveness was measured in terms of life expectancy (LE) and quality-adjusted life expectancy (QALE). Health utility indexes derived from published literature took into account dialysis, CV events and fractures.
The simulated mean LE extension in patients receiving cinacalcet was 1.20 life-years (LY) in Italy, 1.10 LY in Spain, 1.18 LY in Portugal, 1.10 LY in the Czech Republic and 1.40 LY in Switzerland. QALE increase was 0.89, 0.82, 0.89, 0.80 and 1.01 QALY in the same countries, respectively. The incremental cost-effectiveness ratio (ICER) result was €23,500/LY and €31,600/QALY in Italy, €21,800/LY and €29,300/QALY in Spain, €23,700/LY and €31,200/QALY in Portugal, €29,700/LY and €40,800/QALY in the Czech Republic and €24,700/LY and €34,200/QALY in Switzerland. Including dialysis costs as a part of the total costing doubled the ICER, from a minimum of €42,800/LY in Spain to a maximum of €82,800/LY in Switzerland and in the range from €57,500/QALY (Spain) to €114,700/QALY (Switzerland).
Taking into consideration the limited clinical, epidemiological and health economics data available, cinacalcet treatment showed a relatively good cost-effectiveness profile in all the countries analysed, despite the differences in their healthcare systems and economic wealth.
之前使用来自意大利的本地数据，开发了一个概率性患者水平马尔可夫模型，用于模拟继发性甲状旁腺功能亢进症 (SHPT) 患者使用西那卡塞治疗的终生临床和经济结局。本研究将模型应用扩展到其他四个欧洲国家 - 西班牙、葡萄牙、瑞士和捷克共和国，以评估结果的一致性。
西那卡塞影响甲状旁腺激素、血清钙和磷的水平。我们的模拟基于 OPTIMA（使用西那卡塞改善终末期肾脏病患者 KDOQI 目标的开放标签、随机研究）随机对照试验的数据，以及骨代谢参数、死亡率和发病率（心血管[CV]事件、骨折和甲状旁腺切除术）之间的已发表相关性。将本地透析、药物和事件管理的流行病学和成本数据纳入模型。模拟的时间范围是患者的终生；比较了 SHPT 的标准治疗（维生素 D 固醇和磷酸盐结合剂）和西那卡塞加标准治疗。使用生命预期（LE）和质量调整生命预期（QALE）来衡量有效性。从已发表文献中得出的健康效用指数考虑了透析、CV 事件和骨折。
在接受西那卡塞治疗的患者中，模拟的平均 LE 延长分别为意大利 1.20 生命年（LY）、西班牙 1.10 LY、葡萄牙 1.18 LY、捷克共和国 1.10 LY 和瑞士 1.40 LY。在相同的国家，QALE 增加分别为 0.89、0.82、0.89、0.80 和 1.01 QALY。意大利的增量成本效益比（ICER）结果为 23500 欧元/LY 和 31600 欧元/QALY，西班牙为 21800 欧元/LY 和 29300 欧元/QALY，葡萄牙为 23700 欧元/LY 和 31200 欧元/QALY，捷克共和国为 29700 欧元/LY 和 40800 欧元/QALY，瑞士为 24700 欧元/LY 和 34200 欧元/QALY。将透析费用作为总成本的一部分考虑在内，将 ICER 加倍，从西班牙的最低 42800 欧元/LY 增加到瑞士的最高 82800 欧元/LY，范围从西班牙的 57500 欧元/QALY（西班牙）到瑞士的 114700 欧元/QALY（瑞士）。
考虑到可用的有限临床、流行病学和健康经济学数据，西那卡塞治疗在所有分析的国家中都显示出相对较好的成本效益比，尽管它们的医疗保健系统和经济财富存在差异。
