Jacobson Vann Julie, Feaganes John, Wegner Steven
School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7460, USA.
Pharmacoeconomics. 2007;25(9):793-800. doi: 10.2165/00019053-200725090-00007.
Palivizumab is one of the most costly paediatric medications for Medicaid and other health plans. It is uncertain whether the costs of palivizumab administration are justified in specific risk groups. Ongoing investigations of palivizumab require identification of reliable data sources.
To estimate the reliability between Medicaid paid claims data and medical records documentation in a cost analysis of palivizumab.
A cross-sectional study of data reliability was performed within a cost analysis study of palivizumab in a cohort of at-risk patients during the US 2002/3 respiratory syncytial virus season. Exposure classification (to palivizumab prophylaxis) was compared using Medicaid claims and medical records data.
The study was performed in 28 widely dispersed paediatric medical practices serving North Carolina, USA Medicaid patients within the AccessCare/Community Care of North Carolina (CCNC) Program, an enhanced primary care case management programme. Patients were eligible if they were born between 1 March 2002 and 28 February 2003 at 32-35 weeks estimated gestational age, were enrolled in the North Carolina primary care case management Medicaid programme during the study period and were patients of the participating practices. Medicaid healthcare claims were obtained in December 2003 for services provided between October 2002 and May 2003. Medical records were abstracted by community-based case managers. Primary variables included frequency, dates and dose of palivizumab injections. The main outcomes measures were agreement in the number of palivizumab injections, dates of administration and doses of palivizumab between Medicaid paid claims and medical record data.
Injection frequencies matched between medical record and Medicaid claims data for only 46.2% of study participants. Congruence in injection service dates occurred between data sources for only 1% of injections. Doses were similar between data sources for 81.9% of injections.
In Medicaid recipients receiving palivizumab injection, Medicaid claims data were inconsistent with medical records data. Use of multiple data sources and validation are recommended to identify temporal relationships between drug administration and endpoints of interest.
帕利珠单抗是医疗补助计划(Medicaid)和其他医保计划中最昂贵的儿科药物之一。对于特定风险群体,帕利珠单抗的给药成本是否合理尚不确定。正在进行的帕利珠单抗研究需要确定可靠的数据来源。
在帕利珠单抗成本分析中评估医疗补助计划付费索赔数据与病历记录之间的可靠性。
在美国2002/3呼吸道合胞病毒流行季节,对一组高危患者进行帕利珠单抗成本分析研究期间,开展了一项数据可靠性的横断面研究。使用医疗补助计划索赔数据和病历数据比较暴露分类(帕利珠单抗预防)情况。
该研究在28个分布广泛的儿科医疗诊所进行,这些诊所为美国北卡罗来纳州医疗补助计划患者提供服务,属于北卡罗来纳州增强初级保健病例管理计划(AccessCare/Community Care of North Carolina,CCNC)。符合条件的患者为2002年3月1日至2003年2月28日出生、估计孕周为32 - 35周、在研究期间参加北卡罗来纳州初级保健病例管理医疗补助计划且是参与诊所患者。2003年12月获取了2002年10月至2003年5月期间提供服务的医疗补助计划医疗索赔数据。由社区病例管理人员提取病历。主要变量包括帕利珠单抗注射频率、日期和剂量。主要结局指标是医疗补助计划付费索赔数据与病历数据之间帕利珠单抗注射次数、给药日期和剂量的一致性。
仅46.2%的研究参与者病历记录与医疗补助计划索赔数据中的注射频率相符。数据来源之间注射服务日期的一致性仅为1%的注射情况。81.9%的注射情况数据来源之间剂量相似。
在接受帕利珠单抗注射的医疗补助计划受助者中,医疗补助计划索赔数据与病历数据不一致。建议使用多个数据来源并进行验证,以确定药物给药与感兴趣的终点之间的时间关系。