Katherine A. Clifford, Tufts Medical Center, Boston, Massachusetts.
A. Alex Levine, Tufts Medical Center.
Health Aff (Millwood). 2024 Nov;43(11):1546-1552. doi: 10.1377/hlthaff.2024.00363.
The Inflation Reduction Act of 2022 requires that Medicare negotiate a Maximum Fair Price for selected small-molecule drugs nine years after their Food and Drug Administration (FDA) approval and thirteen years postapproval for selected biologics. The discrepancy between these time frames raises questions about the relative value of small-molecule drugs versus biologics. We compared the incremental quality-adjusted life-year (QALY) gains, incremental costs, and incremental cost-effectiveness ratios (ICERs) of small-molecule drugs and biologics approved by the FDA during the period 1999-2018. We used the Mann-Whitney U test (to compare medians) and Kolmogorov-Smirnov test (to compare the distributions). We found that small-molecule drugs and biologics offer similar magnitudes of incremental QALY gains (0.08 versus 0.10). Small-molecule drugs tend to be associated with lower additional costs ($4,738 versus $16,020) and more favorable cost-effectiveness ($108,314 per QALY versus $228,286 per QALY). Creating parity regarding time to Medicare price negotiation may be appropriate.
2022 年《降低通胀法案》要求，在获得食品和药物管理局 (FDA) 批准后 9 年，以及获得 FDA 批准后 13 年，对选定的小分子药物和生物制剂进行医保谈判，以确定最高公平价格。这些时间框架之间的差异引发了关于小分子药物与生物制剂相对价值的问题。我们比较了 1999 年至 2018 年期间 FDA 批准的小分子药物和生物制剂的增量质量调整生命年 (QALY) 获益、增量成本和增量成本效益比 (ICER)。我们使用了 Mann-Whitney U 检验（用于比较中位数）和 Kolmogorov-Smirnov 检验（用于比较分布）。我们发现小分子药物和生物制剂提供的增量 QALY 获益幅度相似（0.08 与 0.10）。小分子药物往往与较低的额外成本（4738 美元与 16020 美元）和更有利的成本效益相关（每 QALY 为 108314 美元与每 QALY 为 228286 美元）。关于医保价格谈判时间的均等化可能是合适的。
