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目的:利用经济学模型,评价应用基础胰岛素治疗的中国2型糖尿病(T2DM)患者转换为双时相门冬胰岛素30(BIAsp30)联用二甲双胍治疗的长期经济与健康产出,证明BIAsp30的成本效果价值,旨在为临床医生和患者合理用药提供参考依据。方法:应用糖尿病CORE模型,计算患者长期(30年)的糖尿病治疗总成本、期望寿命和质量调整生命年。CORE模型是一项已发表的、经过验证和专家评审的、计算机模拟的糖尿病模型。293例中国T2DM患者的临床基线和治疗数据来自于一项16周、多中心和非随机无对照的用于评价基础胰岛素转用BIAsp30联合二甲双胍(MET)治疗的安全性与有效性的临床试验(NCT00614120)。其中基础胰岛素分为2个亚组,甘精胰岛素(IGla)联合MET组和中性鱼精蛋白锌胰岛素(NPH)联合MET组。药物和血糖检测的成本以市场价格计算,并发症及其管理成本是基于2008年已发表文献中的中国三级医院的糖尿病及其并发症成本数据进行CPI调整至2009年。本研究中的成本以直接医疗成本计算,包括降糖药物、血糖检测和糖尿病并发症的成本。直接医疗成本和质量调整生命年的年贴现率根据2006年中国药物经济学指南设定为3%。应用单因素敏感度分析评估研究结果的稳定性。结果:根据患者从使用IGla组转用BIAsp30联用MET治疗16周后的数据推算终身(30年)结果,治疗成本减少46 540元,期望寿命增加(0.347±0.245)年,质量调整生命年增加了(0.327±0.174)QALY。从使用NPH组转用BIAsp30治疗后,治疗成本增加19 525元,期望寿命增加(0.452±0.242)年,质量调整生命年增加了(0.393±0.169)QALY,计算得出增量成本效果比值(ICER)为49 730元/QALY。敏感性分析进一步验证了结果的稳健性。结论:从基础胰岛素转用BIAsp30联用MET治疗后,期望寿命与质量调整生命年均得到了增加。IGlar转用BIAsp30治疗后,减少治疗总成本。NPH转用BIAsp30治疗后,治疗总成本有所增加,但计算出的ICER值低于WHO建议的阈值(中国2009年人均GDP的3倍),处于可接受范围。因此,BIAsp30相对于IGla治疗是成本节约方案,相对于NPH治疗是成本效果方案。
OBJECTIVE: To evaluate the long-term economic and health outcomes of BIAsp30 combined with metformin in Chinese patients with type 2 diabetes mellitus (T2DM) treated with basal insulin using an economic model to demonstrate the cost-effectiveness of BIAsp30 Value, designed for clinicians and patients to provide a reasonable basis for the use of drugs. METHODS: CORE model of diabetes was used to calculate the long-term (30 years) total cost of diabetes treatment, life expectancy and quality adjusted life span. The CORE model is a published, validated and expertly reviewed, computer-generated model of diabetes. Clinical baseline and treatment data for 293 Chinese patients with T2DM were derived from a 16-week, multicenter, non-randomized, controlled clinical trial evaluating the safety and efficacy of basal insulin switching to BIAsp30 plus metformin (MET) NCT00614120). Basal insulin was divided into two subgroups: IGla combined with MET group and neutral protamine zinc insulin (NPH) with MET group. Costs for drug and blood glucose testing are based on market prices. Complications and management costs are adjusted based on CPI from 2009 to 2009 based on data on the costs of diabetes and its complications in tertiary hospitals in China published in 2008. The costs in this study were calculated on direct medical costs, including the costs of hypoglycemic drugs, glycemic test, and diabetic complications. The annual discount rate for direct medical costs and quality adjusted life years is set at 3% based on the 2006 China Pharmacoeconomics Guidelines. The single factor sensitivity analysis was used to assess the stability of the study results. RESULTS: Based on data from 16 weeks after switching to IGAs with BIAsp30 in combination with MET, life-long (30-year) predictions showed a reduction in treatment costs of 46 540 yuan, an expected life expectancy of 0.347 ± 0.245 years and an increase in mass adjusted life years (0.327 ± 0.174) QALY. After switching from using NPH to BIAsp30, the cost of treatment increased by 19 525 yuan, the expected life expectancy increased (0.452 ± 0.242) years, and the mass adjusted life year increased by (0.393 ± 0.169) QALY. The cost-effective ratio (ICER ) For 49 730 yuan / QALY. Sensitivity analysis further verifies the robustness of the results. CONCLUSIONS: Life expectancy and quality adjusted life years have been increased from basal insulin to BIAsp30 in combination with MET. IGlar switch to BIAsp30 treatment, reducing the total cost of treatment. After the conversion of NPH to BIAsp30, the total cost of treatment increased, but the calculated ICER value was below the WHO recommended threshold (China’s 2009 GDP per capita of 3 times), in an acceptable range. Therefore, BIAsp30 relative to IGla treatment is a cost-saving program, compared with NPH treatment is a cost-effective program.