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大型管理式医疗人群中每位有效治疗的类风湿关节炎患者的生物制剂成本:一项回顾性队列研究。

Biologic Cost per Effectively Treated Rheumatoid Arthritis Patient in a Large Managed Care Population: A Retrospective Cohort Study.

作者信息

Gu Tao, Shah Neel, Deshpande Gaurav, Tang Derek H, Eisenberg Debra F, Harrison David J

机构信息

HealthCore, Wilmington, DE.

Amgen Inc., Thousand Oaks, CA.

出版信息

J Health Econ Outcomes Res. 2015 Sep 17;3(2):122-131. doi: 10.36469/9830. eCollection 2016.

Abstract

Until recently, the lack of clinical outcomes information for rheumatoid arthritis (RA) in administrative claims databases limited their use in comparative effectiveness research. A validated claims-based algorithm has been developed to estimate the effectiveness of biologics for RA, allowing for estimation of cost and effectiveness in the same database. To implement a validated claims-based effectiveness algorithm in a US managed care claims database to compute the 1-year biologic cost per effectively treated patient among first-line biologics approved for moderate-to-severe RA (abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, and infliximab). This retrospective cohort study used administrative claims data for individuals in the HealthCore Integrated Research Database (HIRDSM). The first claim for a first-line biologic between July 1, 2009, and January 31, 2013, after 6 months of continuous enrollment, was defined as the index event and date. Patients were aged 18-63 years on the index date and had at least one claim for RA in the 6-month pre- index period. Biologic costs included plan and patient paid amounts on claims for the biologic drug and administration. The algorithm defined effectiveness during the 12-month post-index period as achieving all six of the following: high adherence (medication possession ratio ≥80% or infusions consistent with the product label); no increase in biologic dose or decrease in dosing interval; no new biologic; no new nonbiologic disease-modifying antirheumatic drug; no new or increased oral glucocorticoid use; and ≤1 glucocorticoid injection. Cost per effectively treated patient was calculated as the total biologic cost (drug and administration) divided by the number of patients categorized by the algorithm as effectively treated. The cohort comprised 4844 patients (mean age 48.6 years, 76.4% female). Average first-year biologic cost ranged from $14 795 (golimumab) to $19 520 (abatacept). Average first-year biologic cost per effectively treated patient was significantly lower for etanercept ($50 217) than for golimumab ($56 427, p<0.001) adalimumab ($56 879, p<0.001), abatacept ($68 062, p<0.001), certolizumab pegol ($76 427, p<0.001), and infliximab ($95 126, p<0.001). In this application of a validated claims-based algorithm to a large managed care population, etanercept had the lowest 1-year biologic cost per effectively treated patient among first-line biologics.

摘要

直到最近,行政索赔数据库中缺乏类风湿性关节炎(RA)的临床疗效信息,限制了它们在比较疗效研究中的应用。一种经过验证的基于索赔的算法已被开发出来,用于估计生物制剂对RA的疗效,从而能够在同一数据库中估计成本和疗效。在美国管理式医疗索赔数据库中实施一种经过验证的基于索赔的疗效算法,以计算在批准用于中重度RA的一线生物制剂(阿巴西普、阿达木单抗、聚乙二醇化赛妥珠单抗、依那西普、戈利木单抗和英夫利昔单抗)中,每例有效治疗患者的1年生物制剂成本。这项回顾性队列研究使用了HealthCore综合研究数据库(HIRDSM)中个体的行政索赔数据。2009年7月1日至2013年1月31日期间,在连续登记6个月后首次使用一线生物制剂的索赔被定义为索引事件和日期。索引日期时患者年龄在18 - 63岁之间,且在索引前6个月内至少有一次RA索赔。生物制剂成本包括保险计划和患者支付的生物制剂药物及给药费用。该算法将索引后12个月期间的疗效定义为实现以下所有六项:高依从性(药物持有率≥80%或输注符合产品标签);生物制剂剂量无增加或给药间隔无缩短;未使用新的生物制剂;未使用新的非生物改善病情抗风湿药;未使用新的或增加剂量的口服糖皮质激素;以及≤1次糖皮质激素注射。每例有效治疗患者的成本计算为生物制剂总成本(药物和给药)除以算法归类为有效治疗的患者数量。该队列包括4844例患者(平均年龄48.6岁,76.4%为女性)。第一年生物制剂平均成本从14795美元(戈利木单抗)到19520美元(阿巴西普)不等。依那西普每例有效治疗患者的第一年生物制剂平均成本(50217美元)显著低于戈利木单抗(56427美元,p<0.001)、阿达木单抗(56879美元,p<0.001)、阿巴西普(68062美元,p<0.001)、聚乙二醇化赛妥珠单抗(76427美元,p<0.001)和英夫利昔单抗(95126美元,p<0.001)。在将经过验证的基于索赔的算法应用于大量管理式医疗人群的研究中,依那西普在一线生物制剂中每例有效治疗患者的1年生物制剂成本最低。

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