Department of Pharmacy, University of Groningen, Antonius Deusinglaan 1, Groningen,The Netherlands.
Clin Ther. 2012 Jul;34(7):1531-43. doi: 10.1016/j.clinthera.2012.06.006. Epub 2012 Jun 27.
Hyperphosphatemia is a common and potentially harmful condition in patients with end-stage kidney disease. In Canada, first-line treatment of hyperphosphatemia consists primarily of calcium carbonate (CC). Lanthanum carbonate (LC) and sevelamer hydrochloride (SH) are non-calcium phosphate binders that have been used as second-line therapy in patients intolerant of or not responsive to CC.
The primary objective of the present study was to assess the costs and clinical benefits of second-line use of LC after therapy failure with CC in patients receiving dialysis, from a Canadian payer perspective. The secondary objective was to perform an economic comparison between second-line LC therapy and second-line SH therapy, from a Canadian payer perspective. Short-term outcomes were treatment response and cost per additional responder, and long-term outcomes were survival, number of all-cause hospitalizations, and quality of life.
A cost-effectiveness Markov model was populated with simulated cohorts of 1000 patients receiving incident dialysis, followed life-long. Patients not responsive to CC with a serum phosphate concentration >1.78 mmol/L (>5.5 mg/dL) received a trial regimen with LC. Patients not responsive to LC returned to CC therapy. Patient data from a randomized controlled trial of 800 patients receiving dialysis were used. Extensive (probabilistic) sensitivity analyses were performed. When available, model parameters were based on Canadian data or from a Canadian perspective. All costs are in 2010 Canadian dollars (C$).
Results of the model estimated that in patients responsive to second-line LC therapy, survival increased, on average, 0.44 years (95% confidence interval [CI], 0.35-0.54) per patient when compared with continued CC therapy. The mean (range) costs per patient in the first year of treatment with LC was C$2600 (C$2400-C$2800). Over patients' lifetimes, the second-line LC strategy resulted in a gain of 48.8 (37.1-61.3) life-years and 29.3 (21.4-38.1) quality-adjusted life-years (QALYs). The cost-effectiveness of the second-line LC strategy was C$7900 (C$1800-C$14,600) per life-year and C$13,200 (C$3000-C$25,100) per QALY gained. Most sensitivity analyses did not change the cost-effectiveness outcomes; however, including unrelated future costs raised the incremental cost-effectiveness ratio to C$159,500 (95% confidence interval, C$133,300-C$191,600) per QALY gained. Compared with second-line SH therapy, second-line LC therapy had similar effectiveness and was 23% less expensive.
Second-line treatment with LC is cost-effective in the treatment of end-stage kidney disease in patients with hyperphosphatemia, from a Canadian payer perspective. Second-line treatment with LC is less expensive, with similar effectiveness as second-line treatment with SH. The primary limitation of health economic evaluations of phosphate binders is the relative scarcity of clinical data on the association between phosphate concentration and long-term outcome.
高磷血症是终末期肾病患者的一种常见且潜在有害的病症。在加拿大,高磷血症的一线治疗主要包括碳酸钙(CC)。碳酸镧(LC)和盐酸司维拉姆(SH)是非钙磷酸盐结合剂,在不能耐受或对 CC 无反应的患者中,它们被用作二线治疗。
本研究的主要目的是从加拿大支付者的角度评估在接受透析治疗的患者中,在 CC 治疗失败后使用 LC 作为二线治疗的成本和临床获益。次要目的是从加拿大支付者的角度,对 LC 二线治疗与 SH 二线治疗进行经济比较。短期结局是治疗反应和每增加一个反应者的成本,长期结局是生存率、全因住院次数和生活质量。
使用模拟队列模型,对 1000 名接受透析治疗的新发病例患者进行了终生随访。血清磷浓度>1.78mmol/L(>5.5mg/dL)且对 CC 无反应的患者接受 LC 试验方案。对 LC 无反应的患者则恢复 CC 治疗。该模型使用了一项 800 名接受透析治疗患者的随机对照试验的数据。进行了广泛的(概率)敏感性分析。当可用时,模型参数基于加拿大数据或从加拿大的角度得出。所有成本均以 2010 年加拿大元(C$)表示。
模型结果估计,与继续使用 CC 治疗相比,在对二线 LC 治疗有反应的患者中,平均每位患者的生存率提高了 0.44 年(95%置信区间,0.35-0.54)。第一年使用 LC 治疗的每位患者的平均(范围)成本为 2600C$(2400C$-2800C$)。在患者的一生中,二线 LC 策略可获得 48.8(37.1-61.3)个生命年和 29.3(21.4-38.1)个质量调整生命年(QALY)。二线 LC 策略的成本效益为每获得 1 个生命年为 7900C$(1800C$-14600C$),每获得 1 个 QALY 为 13200C$(3000C$-25100C$)。大多数敏感性分析并未改变成本效益结果;然而,包括不相关的未来成本将增量成本效益比提高到每获得 1 个 QALY 为 159500C$(95%置信区间,133300C$-191600C$)。与二线 SH 治疗相比,二线 LC 治疗具有相似的疗效,且成本降低了 23%。
从加拿大支付者的角度来看,LC 二线治疗对高磷血症终末期肾病患者是具有成本效益的。LC 二线治疗的成本更低,与 SH 二线治疗的疗效相当。磷酸盐结合剂的健康经济评估的主要局限性在于磷浓度与长期结局之间关联的临床数据相对较少。