Feng Kimberly, Kesselheim Aaron S, Russo Massimiliano, Rome Benjamin N
Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Massachusetts, Boston, USA.
Harvard Medical School, Boston, Massachusetts, USA.
Clin Pharmacol Ther. 2023 Jan;113(1):90-97. doi: 10.1002/cpt.2763. Epub 2022 Nov 1.
After market exclusivity ends for biologic drugs, biosimilars-follow-on versions made by other manufacturers-can compete with lower prices. Biosimilars have modestly reduced prescription drug spending for US payers, but it is unclear whether patients have directly experienced any savings. In this study we assessed whether availability of biosimilar infliximab was associated with lower out-of-pocket (OOP) costs, using claims from a national data set of commercially insured patients from 2014 to 2018. We used two-part models, adjusting for patient demographics, clinical characteristics, insurance plan type, and calendar month. Compared with the reference biologic, there was no difference in the percentage of biosimilar claims with OOP costs (30.1% vs. 30.8%; adjusted odds ratio (aOR) 0.98, 95% confidence interval (CI), 0.84-1.15, P = 0.84) or the average nonzero OOP cost (median $378 vs. $538, adjusted mean ratio (aMR) 0.97, 95% CI, 0.80-1.18, P = 0.77). The percentage of claims with OOP costs was lower after biosimilar competition (30.7% vs. 35.0%, aOR 0.96, 95% CI, 0.94-0.99, P = 0.003), but average nonzero costs increased (median $534 vs. $520, aMR 1.04, 95% CI, 1.01-1.07, P = 0.004). Thus, early biosimilar infliximab competition did not improve affordability for patients. Policymakers need to better assure that competition in the biosimilar market translates to lower costs for patients using these medications.
生物制剂的市场独占期结束后,由其他制造商生产的生物类似药(后续版本)能够以更低的价格参与竞争。生物类似药已适度降低了美国医保支付方的处方药支出,但尚不清楚患者是否直接从中节省了费用。在本研究中,我们利用2014年至2018年全国商业保险患者数据集的理赔数据,评估了生物类似药英夫利昔单抗的可及性是否与更低的自付费用相关。我们使用了两部分模型,并对患者人口统计学特征、临床特征、保险计划类型和日历月份进行了调整。与参比生物制剂相比,产生自付费用的生物类似药理赔百分比(30.1%对30.8%;调整优势比(aOR)0.98,95%置信区间(CI),0.84 - 1.15,P = 0.84)或平均非零自付费用(中位数378美元对538美元,调整均值比(aMR)0.97,95% CI,0.80 - 1.18,P = 0.77)并无差异。生物类似药竞争后产生自付费用的理赔百分比更低(30.7%对35.0%,aOR 0.96,95% CI,0.94 - 0.99,P = 0.003),但平均非零费用有所增加(中位数534美元对520美元,aMR 1.04,95% CI,1.01 - 1.07,P = 0.004)。因此,早期生物类似药英夫利昔单抗的竞争并未提高患者的可承受性。政策制定者需要更好地确保生物类似药市场的竞争能够转化为使用这些药物的患者更低的费用。
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