Mulligan Karen, Baid Drishti, Manetas Maria-Alice, Lakdawalla Darius N
Sol Price School of Public Policy, University of Southern California, Los Angeles.
Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, California.
JAMA Health Forum. 2025 Sep 5;6(9):e253076. doi: 10.1001/jamahealthforum.2025.3076.
The US Inflation and Reduction Act (IRA) prohibits the Centers for Medicare & Medicaid Services (CMS) from using discriminatory methods such as cost-effectiveness analysis (CEA) that assign lower value to treating sicker and disabled persons. Generalized risk-adjusted cost- effectiveness (GRACE) provides a nondiscriminatory alternative, but the potential impact on health care budgets is unknown.
To compare value-based drug prices based on traditional CEA with those based on IRA-compliant GRACE and assess the implications for health care budgets.
In this economic evaluation, GRACE was implemented using the direct-utility method and estimated the resulting value-based prices and total budget impact. Model inputs were derived from CEAs published by the Institute for Clinical and Economic Review (ICER) between 2014 and 2024. Data from 302 CEA results for pharmaceuticals published across 72 studies were extracted. The final analysis sample consisted of 259 observations (219 treatment-comparator pairs) across 53 distinct diseases, some of which had subgroup results.
Value-based prices under GRACE and CEA were estimated. A 1-year budget impact was calculated, measured as total drug expenditures using value-based prices assuming a willingness-to-pay threshold of $150 000. The data were analyzed from October 2024 to May 2025.
The mean value-based prices were 7.5% higher under GRACE than under CEA (IQR, -3.9% to 9.1%). Furthermore, compared with traditional CEA, GRACE increased value-based prices for more severe diseases and decreased them for milder diseases. Twenty-four drugs (8 from the top population size quartile) cost less under GRACE; total spending was 3.3% lower under GRACE for these drugs. The remaining 45 drugs (13 from the bottom population size quartile) cost more under GRACE, resulting in 14.7% higher spending for these drugs. Taken together, GRACE increased the total budget by 2%..
This economic evaluation found that although GRACE does increase value-based prices on average, the net effect on total health care spent is minimal, in part because resources are redistributed toward more severe, less prevalent illnesses.
美国《降低通胀法案》（IRA）禁止医疗保险和医疗补助服务中心（CMS）使用诸如成本效益分析（CEA）等歧视性方法，这些方法会降低对病情较重和残疾患者治疗的价值评估。广义风险调整成本效益法（GRACE）提供了一种非歧视性替代方案，但对医疗保健预算的潜在影响尚不清楚。
比较基于传统成本效益分析的基于价值的药品价格与符合《降低通胀法案》的广义风险调整成本效益法的药品价格，并评估对医疗保健预算的影响。
在这项经济评估中，采用直接效用法实施广义风险调整成本效益法，并估计由此产生的基于价值的价格和总预算影响。模型输入数据来自临床与经济评论研究所（ICER）在2014年至2024年期间发表的成本效益分析。从72项研究中发表的302份药品成本效益分析结果中提取数据。最终分析样本包括53种不同疾病的259个观察值（219个治疗-对照对），其中一些有亚组结果。
估计广义风险调整成本效益法和成本效益分析下基于价值的价格。计算1年预算影响，以基于价值的价格计算的药品总支出衡量，假设支付意愿阈值为15万美元。数据于2024年10月至2025年5月进行分析。
广义风险调整成本效益法下基于价值的平均价格比成本效益分析下高7.5%（四分位间距为-3.9%至9.1%）。此外，与传统成本效益分析相比，广义风险调整成本效益法提高了病情较重疾病的基于价值的价格，降低了病情较轻疾病的价格。24种药物（来自人口规模四分位顶端的8种）在广义风险调整成本效益法下成本更低；这些药物在广义风险调整成本效益法下的总支出低3.3%。其余45种药物（来自人口规模四分位底端的13种）在广义风险调整成本效益法下成本更高，这些药物的支出高出14.7%。总体而言，广义风险调整成本效益法使总预算增加了2%。
这项经济评估发现，虽然广义风险调整成本效益法平均确实提高了基于价值的价格，但对医疗保健总支出的净影响很小，部分原因是资源重新分配到了病情更严重、发病率更低的疾病上。
