Palmer James L, Gibbs Meaghan, Scheijbeler Huib W K F H, Kotchie Robert W, Nielsen Steffen, White Jeremy, Valentine William J
IMS Health, Basel, Switzerland.
Adv Ther. 2008 Aug;25(8):752-74. doi: 10.1007/s12325-008-0080-4.
Type 2 diabetes is an increasing problem in China, yet there is a paucity of data regarding the cost-effectiveness of pharmacological interventions in the Chinese setting.
Previous data were obtained from PRESENT (Physicians' Routine Evaluation of Safety and Efficacy of NovoMix 30 Therapy), a multi-country, single-arm, observational study where type 2 diabetes patients poorly controlled with biphasic human insulin (BHI) were converted to biphasic insulin aspart 30 (BIAsp30); the Chinese subgroup experienced an improvement in HbA(1c) and a reduction in hypoglycaemic events. A published and validated computer simulation model of diabetes (the CORE Diabetes Model) was used to estimate the long-term clinical and cost consequences of switching to BIAsp30 from BHI in the Chinese setting. Treatment effects and patient characteristics were derived from PRESENT and country-specific published sources. Primary research was performed to ascertain patient management practices and diabetes-related complication costs. Risks of modelled complications were derived from landmark clinical trials and epidemiological studies. Costs and clinical projections were made over patient lifetimes from a third-party payer perspective and discounted at 3% annually. Extensive sensitivity analyses were performed.
Conversion to BIAsp30 from BHI was projected to improve discounted life expectancy by 0.38 years per patient (9.91 vs 9.53 years) and quality-adjusted life expectancy by 0.91 quality-adjusted life years (QALYs) per patient (6.32 vs 5.41 QALYs). Conversion to BIAsp30 was associated with increased direct medical costs of Chinese Yuan (CNY) 1751 per patient, due to higher pharmacy and management costs (CNY +19,007), offset by reduced diabetes-related complication costs (CNY -17,254) over patient lifetimes. BIAsp30 was associated with an incremental cost-effectiveness ratio of CNY 1926 per QALY gained.
BIAsp30 was projected to substantially improve clinical outcomes but was associated with increased lifetime medical costs. BIAsp30 would be considered cost-effective in China given a willingness-to-pay threshold of CNY 100,000 per QALY gained in type 2 diabetes patients poorly controlled on BHI.
2型糖尿病在中国是一个日益严重的问题，但在中国背景下，关于药物干预成本效益的数据却很匮乏。
先前的数据来自PRESENT（诺和锐30治疗安全性和有效性的医师常规评估），这是一项多国、单臂观察性研究，其中使用双相人胰岛素（BHI）控制不佳的2型糖尿病患者被转换为门冬胰岛素30（BIAsp30）；中国亚组患者的糖化血红蛋白（HbA1c）有所改善，低血糖事件减少。使用已发表并经验证的糖尿病计算机模拟模型（CORE糖尿病模型）来估计在中国背景下从BHI转换为BIAsp30的长期临床和成本后果。治疗效果和患者特征来自PRESENT及特定国家的已发表资料。开展了初步研究以确定患者管理实践和糖尿病相关并发症成本。模型化并发症的风险来自标志性临床试验和流行病学研究。从第三方支付者的角度对患者一生的成本和临床预测进行了计算，并按每年3%的贴现率进行贴现。进行了广泛的敏感性分析。
预计从BHI转换为BIAsp30可使每位患者的贴现预期寿命提高0.38年（9.91年对9.53年），质量调整预期寿命提高0.91个质量调整生命年（QALYs）（6.32个QALYs对5.41个QALYs）。转换为BIAsp30与每位患者直接医疗成本增加1751元人民币相关，这是由于药房和管理成本较高（增加19,007元人民币），但在患者一生中被糖尿病相关并发症成本的降低（减少17,254元人民币）所抵消。BIAsp30每获得一个QALY的增量成本效益比为1926元人民币。
预计BIAsp30可显著改善临床结局，但与一生医疗成本增加相关。鉴于对于使用BHI控制不佳的2型糖尿病患者，每获得一个QALY的支付意愿阈值为100,000元人民币，在中国BIAsp30将被认为具有成本效益。
