2004-2017 年法国用“附加获益”来确定新抗癌药物的价格。
The use of 'added benefit' to determine the price of new anti-cancer drugs in France, 2004-2017.
机构信息
Law School, Suffolk University, Boston, MA, 02140, USA.
Aix-Marseille Univ, APHM, INSERM, IRD, SESSTIM, Hop Timone, BioSTIC, Marseille, France.
出版信息
Eur J Cancer. 2021 Mar;145:11-18. doi: 10.1016/j.ejca.2020.11.031. Epub 2021 Jan 4.
BACKGROUND
Increasing drug prices strains budgets. Assessing the relation between added benefit and prices can help clinical decision-making and resource allocation.
METHODS
We assessed, over a period of 13 years, the relation between added therapeutic benefit and prices for drugs to treat solid tumours in France using the French High Authority of Health Scale (ASMR) and the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (MCBS).
RESULTS
In total, 36 medications were approved for 68 indications. There was a weak correlation between ASMR and MCBS scales (Spearman's |ρ| = 0.28). Drugs had low added benefit on both ASMR (71%) and MCBS (49%). Mean monthly price for new drugs was €4616 (S.D., €3096), ranging from €1795 to €19,675 and increased by 47% comparing 2004-2012 with 2013-2017. The mean monthly price difference of new drugs over their comparator was €3700 (S.D., €3934) ranging between a €13,853 decrease and a €19,675 increase. There was a weak but statistically significant correlation between ASMR and price (|ρ| = 0.35, p = 0.004) and between MCBS and price (|ρ| = 0.33, p = 0.005). Correlations between added benefit and prices were similar or higher for first indications (ASMR, |ρ| = 0.37, p = 0.030; MCBS, |ρ| = 0.48, p = 0.004). In first indications, mean monthly prices increased €3954 for drugs without ASMR added benefit. The mean annual price and price increase for first indications offering no ASMR benefit was €57,312 and €47,448, respectively.
CONCLUSION
Prices and benefit are weakly correlated. However, prices increased substantially even for drugs with no added benefit.
背景
不断上涨的药品价格给预算带来了压力。评估附加效益与价格之间的关系有助于临床决策和资源配置。
方法
我们使用法国卫生署高评议会（ASMR）和欧洲肿瘤内科学会-临床获益量表（MCBS）评估了 13 年来法国用于治疗实体瘤的药物附加治疗效益与价格之间的关系。
结果
共有 36 种药物获批用于 68 种适应证。ASMR 和 MCBS 量表之间的相关性较弱（Spearman's |ρ|=0.28）。药物在 ASMR（71%）和 MCBS（49%）方面的附加效益均较低。新药物的月平均价格为 4616 欧元（标准差，3096 欧元），范围为 1795 至 19675 欧元，并于 2004-2012 年与 2013-2017 年相比增长了 47%。新药物与其对照药物之间的月平均价格差异为 3700 欧元（标准差，3934 欧元），范围从下降 13853 欧元到增加 19675 欧元不等。ASMR 与价格之间存在微弱但具有统计学意义的相关性（|ρ|=0.35，p=0.004），MCBS 与价格之间也存在相关性（|ρ|=0.33，p=0.005）。附加效益与价格之间的相关性在首次适应证中相似或更高（ASMR，|ρ|=0.37，p=0.030；MCBS，|ρ|=0.48，p=0.004）。在首次适应证中，对于没有 ASMR 附加效益的药物，月平均价格增加了 3954 欧元。对于没有 ASMR 效益的首次适应证药物，平均年价格和价格增长率分别为 57312 欧元和 47448 欧元。
结论
价格和效益之间相关性较弱。然而，即使是没有附加效益的药物，价格也大幅上涨。
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