PDF(Pubmed)
Abstract：
UNASSIGNED: The burden of diabetes is growing worldwide. The costs associated with diabetes put substantial pressure on patients and health budgets, especially in low- and middle-income countries. The prices of diabetes medicines are a key determinant for access, yet little is known about the association between manufacturing costs and current market prices.
UNASSIGNED: To estimate the cost of manufacturing insulins, sodium-glucose cotransporter 2 inhibitors (SGLT2Is), and glucagonlike peptide 1 agonists (GLP1As), derive sustainable cost-based prices (CBPs), and compare these with current market prices.
UNASSIGNED: In this economic evaluation, the cost of manufacturing insulins, SGLT2Is, and GLP1As was modeled. Active pharmaceutical ingredient cost per unit (weighted least-squares regression model using data from a commercial database of trade shipments, data from January 1, 2016, to March 31, 2023) was combined with costs of formulation and other operating expenses, plus a profit margin with an allowance for tax, to estimate CBPs. Cost-based prices were compared with current prices in 13 countries, collected in January 2023 from public databases. Countries were selected to provide representation of different income levels and geographic regions based on the availability of public databases.
UNASSIGNED: Estimated CBPs; lowest current market prices (2023 US dollars).
UNASSIGNED: In this economic evaluation of manufacturing costs, estimated CBPs for treatment with insulin in a reusable pen device could be as low as $96 (human insulin) or $111 (insulin analogues) per year for a basal-bolus regimen, $61 per year using twice-daily injections of mixed human insulin, and $50 (human insulin) or $72 (insulin analogues) per year for a once-daily basal insulin injection (for type 2 diabetes), including the cost of injection devices and needles. Cost-based prices ranged from $1.30 to $3.45 per month for SGLT2Is (except canagliflozin: $25.00-$46.79) and from $0.75 to $72.49 per month for GLP1As. These CBPs were substantially lower than current prices in the 13 countries surveyed.
UNASSIGNED: High prices limit access to newer diabetes medicines in many countries. The findings of this study suggest that robust generic and biosimilar competition could reduce prices to more affordable levels and enable expansion of diabetes treatment globally.
UNASSIGNED: To estimate the cost of manufacturing insulins, sodium-glucose cotransporter 2 inhibitors (SGLT2Is), and glucagonlike peptide 1 agonists (GLP1As), derive sustainable cost-based prices (CBPs), and compare these with current market prices.
UNASSIGNED: In this economic evaluation, the cost of manufacturing insulins, SGLT2Is, and GLP1As was modeled. Active pharmaceutical ingredient cost per unit (weighted least-squares regression model using data from a commercial database of trade shipments, data from January 1, 2016, to March 31, 2023) was combined with costs of formulation and other operating expenses, plus a profit margin with an allowance for tax, to estimate CBPs. Cost-based prices were compared with current prices in 13 countries, collected in January 2023 from public databases. Countries were selected to provide representation of different income levels and geographic regions based on the availability of public databases.
UNASSIGNED: Estimated CBPs; lowest current market prices (2023 US dollars).
UNASSIGNED: In this economic evaluation of manufacturing costs, estimated CBPs for treatment with insulin in a reusable pen device could be as low as $96 (human insulin) or $111 (insulin analogues) per year for a basal-bolus regimen, $61 per year using twice-daily injections of mixed human insulin, and $50 (human insulin) or $72 (insulin analogues) per year for a once-daily basal insulin injection (for type 2 diabetes), including the cost of injection devices and needles. Cost-based prices ranged from $1.30 to $3.45 per month for SGLT2Is (except canagliflozin: $25.00-$46.79) and from $0.75 to $72.49 per month for GLP1As. These CBPs were substantially lower than current prices in the 13 countries surveyed.
UNASSIGNED: High prices limit access to newer diabetes medicines in many countries. The findings of this study suggest that robust generic and biosimilar competition could reduce prices to more affordable levels and enable expansion of diabetes treatment globally.
摘要：
■糖尿病的负担在全球范围内不断增加。与糖尿病相关的成本给患者和健康预算带来了巨大压力，特别是在低收入和中等收入国家。糖尿病药物的价格是获取的关键决定因素，然而，人们对制造成本和当前市场价格之间的联系知之甚少。
■要估算制造胰岛素的成本，钠-葡萄糖协同转运蛋白2抑制剂（SGLT2Is），和胰高血糖素样肽1激动剂（GLP1As），得出可持续的基于成本的价格(CBP)，并将这些与当前市场价格进行比较。
■在这次经济评估中，制造胰岛素的成本，SGLT2Is，和GLP1As建模。单位活性药物成分成本（加权最小二乘回归模型使用来自商业数据库的数据，2016年1月1日至2023年3月31日的数据）与配方成本和其他业务费用相结合，加上利润率和免税额，估计CBPs。将基于成本的价格与13个国家的当前价格进行了比较，2023年1月从公共数据库收集。根据公共数据库的可用性，选择了一些国家来提供不同收入水平和地理区域的代表。
■估计CBPs；当前市场最低价格（2023美元）。
■在这种制造成本的经济评估中，在可重复使用的笔式设备中使用胰岛素治疗的估计CBPs每年可低至96美元（人胰岛素）或111美元（胰岛素类似物），每年61美元，每天两次注射混合人胰岛素，和$50（人胰岛素）或$72（胰岛素类似物）每年一次的基础胰岛素注射（2型糖尿病），包括注射装置和针头的成本。SGLT2Is的基于成本的价格从每月$1.30到$3.45不等（canagliflozin除外：$25.00-$46.79），GLP1As的价格从每月$0.75到$72.49不等。这些CBPs大大低于接受调查的13个国家的当前价格。
■高价格限制了许多国家获得新的糖尿病药物。这项研究的结果表明，强有力的仿制药和生物仿制药竞争可以将价格降低到更实惠的水平，并使全球糖尿病治疗得以扩展。
■要估算制造胰岛素的成本，钠-葡萄糖协同转运蛋白2抑制剂（SGLT2Is），和胰高血糖素样肽1激动剂（GLP1As），得出可持续的基于成本的价格(CBP)，并将这些与当前市场价格进行比较。
■在这次经济评估中，制造胰岛素的成本，SGLT2Is，和GLP1As建模。单位活性药物成分成本（加权最小二乘回归模型使用来自商业数据库的数据，2016年1月1日至2023年3月31日的数据）与配方成本和其他业务费用相结合，加上利润率和免税额，估计CBPs。将基于成本的价格与13个国家的当前价格进行了比较，2023年1月从公共数据库收集。根据公共数据库的可用性，选择了一些国家来提供不同收入水平和地理区域的代表。
■估计CBPs；当前市场最低价格（2023美元）。
■在这种制造成本的经济评估中，在可重复使用的笔式设备中使用胰岛素治疗的估计CBPs每年可低至96美元（人胰岛素）或111美元（胰岛素类似物），每年61美元，每天两次注射混合人胰岛素，和$50（人胰岛素）或$72（胰岛素类似物）每年一次的基础胰岛素注射（2型糖尿病），包括注射装置和针头的成本。SGLT2Is的基于成本的价格从每月$1.30到$3.45不等（canagliflozin除外：$25.00-$46.79），GLP1As的价格从每月$0.75到$72.49不等。这些CBPs大大低于接受调查的13个国家的当前价格。
■高价格限制了许多国家获得新的糖尿病药物。这项研究的结果表明，强有力的仿制药和生物仿制药竞争可以将价格降低到更实惠的水平，并使全球糖尿病治疗得以扩展。
