Background

For patients with type 2 diabetes in low-income and middle-income countries (LMICs), access to newer antidiabetic drugs (eg, sodium–glucose co-transporter-2 [SGLT2] inhibitors, glucagon-like peptide-1 [GLP-1] receptor agonists, and insulin analogues) could reduce the incidence of diabetes-related complications. We aimed to estimate price targets to pursue in negotiations for inclusion in national formularies given the addition of these novel agents to WHO's Essential Medicines List.

Methods

We incorporated individual-level, nationally representative survey data (2006–18) from 23 678 people with diabetes in 67 LMICs into a microsimulation of cardiovascular events, heart failure, end-stage renal disease, vision loss, pressure sensation loss, hypoglycaemia requiring medical attention, and drug-specific side-effects. We estimated price targets for incremental costs of switching to newer treatments to achieve cost-effectiveness (ie, <3-times gross domestic product per disability-adjusted life-year averted) or to achieve net cost-savings when including costs of averted complications. We compared switching to SGLT2 inhibitors or GLP-1 receptor agonists in place of sulfonylureas, or insulin analogues in place of human insulin, and also compared a glycaemia-agnostic pathways of adding SGLT2 inhibitors or GLP-1 receptor agonists to existing therapies for people with heart disease, heart failure, or kidney disease.

Findings

To achieve cost-effectiveness, SGLT2 inhibitors would need to have a median price of $224 per person per year (a 17·4% cost reduction; IQR $138–359, population-weighted across countries; mean price $257); GLP-1 receptor agonists $208 per person per year (98·3% reduction; $129–488; $240); and glargine insulin $20 per vial (31·0% reduction; $16–42; $28). To achieve net cost-savings, price targets would need to reduce by a further $9–10 to a median cost for SGLT2 inhibitors of $214 (21·4% reduction; $148–316; $245) and for GLP-1 receptor agonists to $199 per person per year (98·4% reduction; $138–294; $228); but insulin glargine remained around $20 per vial (32·4% reduction; $15–37; $26). Using SGLT2 inhibitors or GLP-1 receptor agonists in a glycaemia-agnostic pathway produced a 92% reduction (SGLT2 inhibitors) and 72% reduction (GLP-1 receptor agonists) in incremental cost-effectiveness ratios.

Interpretation

Among novel agents, SGLT2 inhibitors hold particular promise for reducing complications of diabetes and meeting common price targets, particularly when used among people with established cardiovascular or kidney disease. These findings are consistent with the choice to include SGLT2 inhibitors in the WHO Essential Medicines List.

Funding

Clinton Health Access Initiative.

中文翻译：

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扩大低收入和中等收入国家 2 型糖尿病患者获得更新药物的机会：成本效益和价格目标分析

背景

对于低收入和中等收入国家 (LMIC) 的 2 型糖尿病患者，获得更新的抗糖尿病药物（例如钠-葡萄糖协同转运蛋白 2 [SGLT2] 抑制剂、胰高血糖素样肽 1 [GLP-1 ] 受体激动剂和胰岛素类似物）可以降低糖尿病相关并发症的发生率。鉴于将这些新型药物添加到世卫组织的基本药物清单中，我们旨在估计在谈判中纳入国家处方集的价格目标。

方法

我们将来自 67 个 LMIC 的 23 678 名糖尿病患者的个人水平、具有全国代表性的调查数据（2006-18 年）纳入心血管事件、心力衰竭、终末期肾病、视力丧失、压力感觉丧失、需要医疗的低血糖的微观模拟。注意和药物特异性副作用。我们估计了转换到新疗法的增量成本的价格目标，以实现成本效益（即，<每避免残疾调整生命年国内生产总值的 3 倍）或在包括避免并发症的成本时实现净成本节约。我们比较了用 SGLT2 抑制剂或 GLP-1 受体激动剂代替磺脲类药物，或用胰岛素类似物代替人胰岛素，

发现

为了实现成本效益，SGLT2 抑制剂的中位价格需要为每人每年 224 美元（成本降低 17·4%；IQR 为 138-359 美元，各国人口加权；平均价格为 257 美元）；GLP-1 受体激动剂每人每年 208 美元（降低 98·3%；129-488 美元；240 美元）；和甘精胰岛素每瓶 20 美元（减少 31·0%；16-42 美元；28 美元）。为了实现净成本节约，价格目标需要进一步降低 9-10 美元，使 SGLT2 抑制剂的中位数成本为 214 美元（降低 21·4%；148-316 美元；245 美元）和 GLP-1 受体激动剂的中位数成本至 199 美元每人每年（减少 98·4%；$138–294；$228）；但甘精胰岛素仍保持在每瓶 20 美元左右（降低 32·4%；15-37 美元；26 美元）。

解释

在新型药物中，SGLT2 抑制剂在减少糖尿病并发症和达到共同价格目标方面特别有希望，特别是在患有心血管或肾脏疾病的人群中使用时。这些发现与将 SGLT2 抑制剂纳入 WHO 基本药物清单的选择是一致的。

资金

克林顿健康获取倡议。