HEXOR (Pty) Ltd, Block J, Central Park, 400 16th Road, Midrand, Gauteng, South Africa.
S Afr Med J. 2013 Feb 15;103(4):241-5. doi: 10.7196/samj.6471.
Dabigatran is an oral anticoagulant direct thrombin inhibitor recently registered in South Africa (SA) to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation (AF). Owing to the price disparity between warfarin (the current gold standard for treatment of patients with AF) and dabigatran, we conducted an economic appraisal of the use of dabigatran compared with warfarin from a payer perspective in the South African private healthcare setting.
To estimate the cost-effectiveness (CE) and budget impact of dabigatran compared with warfarin for the prevention of stroke in AF patients. Methods. A previously published Markov model was populated with SA cost and mortality data to estimate the CE and budget impact analysis of dabigatran over a lifetime horizon. The model population consisted of a cohort of patients of whom those aged younger than 80 years used dabigatran 150 mg twice daily and those older than 80 years 110 mg twice daily. Modelled outcomes included total cost, quality-adjusted life years (QALYs) and incremental CE ratio (ICER), with the effectiveness measured by QALYs gained.
Dabigatran compared with warfarin as first-line treatment was estimated to have an ICER of R93 290 and an average incremental cost per beneficiary per month of R0.39 over a 5-year period. Conservative assumptions were made regarding the number of international normalised ratio monitoring tests for patients on warfarin, and the ICER is estimated to decrease by as much as 15.7% under less stringent assumptions. A robust sensitivity analysis was also performed.
Dabigatran as first-line treatment compared with warfarin for the use of stroke prevention in patients with AF is deemed cost-effective when used in accordance with its registered indication in the SA private sector.
达比加群酯是一种新型的口服抗凝药物，直接作用于凝血酶，最近在南非（SA）注册，用于降低房颤（AF）患者中风和全身性栓塞的风险。由于华法林（目前 AF 患者治疗的金标准）和达比加群酯之间的价格差异，我们从支付者的角度对达比加群酯在南非私立医疗保健环境中的使用进行了经济评估，与华法林进行比较。
从支付者的角度评估达比加群酯与华法林预防 AF 患者中风的成本效益（CE）和预算影响。方法。使用先前发表的 Markov 模型，结合南非的成本和死亡率数据，估计达比加群酯在终生范围内与华法林相比的 CE 和预算影响分析。模型人群由一组患者组成，其中年龄小于 80 岁的患者使用达比加群酯 150mg，每日两次，年龄大于 80 岁的患者使用 110mg，每日两次。模型结果包括总费用、质量调整生命年（QALYs）和增量 CE 比（ICER），以 QALYs 作为有效性的衡量标准。
与华法林作为一线治疗相比，达比加群酯的 ICER 为 93290 兰特，5 年内每个受益人的每月平均增量成本为 39 兰特。对接受华法林治疗的患者进行国际标准化比值监测试验的次数做出了保守的假设，在假设更宽松的情况下，ICER 估计会降低 15.7%。还进行了稳健的敏感性分析。
达比加群酯作为一线治疗，与华法林相比，用于 AF 患者的中风预防，在符合南非私立部门注册适应症的情况下，被认为是具有成本效益的。
