生物药物在美国医药支出中所占的份额越来越大。来自后续生物类似产品的竞争(后续版本与原始生物制品没有临床意义的差异)导致美国医疗保健支出的适度减少,但这些节省可能不会转化为降低患者的自付(OOP)成本.
■调查生物仿制药竞争是否与使用生物制剂的患者的OOP支出降低有关。
■这项队列研究使用了国家商业索赔数据库(OptumClinformaticsDataMart),以确定7种临床医生管理的生物制剂(filgrastim,英夫利昔单抗,pegfilgrastim,epoetinalfa,贝伐单抗,利妥昔单抗,和曲妥珠单抗)从2009年1月到2022年3月。包括65岁以下的商业保险患者的索赔。
■相对于首次生物仿制药的可用性和使用原始或生物仿制药版本的年份。
■确定了每个日历年的患者在生物制剂上的年度OOP支出,比较了参考生物版本和生物仿制药版本之间的每次索赔的OOP支出。两部分回归模型评估了OOP支出的差异,根据患者和临床特征进行调整(年龄,性别,美国人口普查地区,健康计划类型,诊断,和服务地点)和相对于初始生物类似品进入的年份。
■来自190,364人的170万份索赔(年龄中位数,53[42-59]岁;58.3%的女性)在2009年至2022年之间使用了7种生物制剂中的至少1种被纳入分析。超过251566患者年的观察,在生物仿制药可获得性前后,年度OOP成本增加。生物仿制药竞争开始两年后,非零年度OOP支出的校正比值比为1.08(95%CI,1.04-1.12;P<.001),非零年度平均支出比生物仿制药竞争前一年高出12%(95%CI,10%-14%;P<.001).在生物仿制药可用后,对生物仿制药的索赔比参考生物制品更有可能具有非零的OOP成本(调整后的赔率比,1.13[95%CI,1.11-1.16];P<.001),但平均非零OOP成本较低8%(调整后平均比率,0.92[95%CI,0.90-0.93;P<.001)。调查结果因药物而异。
■这项队列研究的结果表明,生物仿制药竞争并不总是与商业保险门诊患者的较低OOP成本相关,强调需要有针对性的政策干预措施,以确保生物仿制药竞争产生的节约转化为增加需要生物制剂的患者的负担能力。
UNASSIGNED: Biologic drugs account for a growing share of US pharmaceutical spending. Competition from follow-on biosimilar products (subsequent versions that have no clinically meaningful differences from the original biologic) has led to modest reductions in US health care spending, but these savings may not translate to lower out-of-pocket (OOP) costs for patients.
UNASSIGNED: To investigate whether biosimilar competition is associated with lower OOP spending for patients using biologics.
UNASSIGNED: This cohort study used a national commercial claims database (Optum Clinformatics Data Mart) to identify outpatient claims for 1 of 7 clinician-administered biologics (filgrastim, infliximab, pegfilgrastim, epoetin alfa, bevacizumab, rituximab, and trastuzumab) from January 2009 through March 2022. Claims by commercially insured patients younger than 65 years were included.
UNASSIGNED: Year relative to first biosimilar availability and use of original or biosimilar version.
UNASSIGNED: Patients\' annual OOP spending on biologics for each calendar year was determined, and OOP spending per claim between reference biologic and biosimilar versions was compared. Two-part regression models assessed for differences in OOP spending, adjusting for patient and clinical characteristics (age, sex, US Census region, health plan type, diagnosis, and place of service) and year relative to initial biosimilar entry.
UNASSIGNED: Over 1.7 million claims from 190 364 individuals (median [IQR] age, 53 [42-59] years; 58.3% females) who used at least 1 of the 7 biologics between 2009 and 2022 were included in the analysis. Over 251 566 patient-years of observation, annual OOP costs increased before and after biosimilar availability. Two years after the start of biosimilar competition, the adjusted odds ratio of nonzero annual OOP spending was 1.08 (95% CI, 1.04-1.12; P < .001) and average nonzero annual spending was 12% higher (95% CI, 10%-14%; P < .001) compared with the year before biosimilar competition. After biosimilars became available, claims for biosimilars were more likely than reference biologics to have nonzero OOP costs (adjusted odds ratio, 1.13 [95% CI, 1.11-1.16]; P < .001) but had 8% lower mean nonzero OOP costs (adjusted mean ratio, 0.92 [95% CI, 0.90-0.93; P < .001). Findings varied by drug.
UNASSIGNED: Findings of this cohort study suggest that biosimilar competition was not consistently associated with lower OOP costs for commercially insured outpatients, highlighting the need for targeted policy interventions to ensure that the savings generated from biosimilar competition translate into increased affordability for patients who need biologics.