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估算长效注射药物的依从性和持久性的方法学考虑。

Methodological considerations in estimating adherence and persistence for a long-acting injectable medication.

机构信息

University of Colorado Anschutz Medical Campus, 13199 E. Montview Blvd., Ste. 300, MS F443, Aurora, CO 80045.

出版信息

J Manag Care Spec Pharm. 2014 Jul;20(7):756-66. doi: 10.18553/jmcp.2014.20.7.756.

Abstract

BACKGROUND

Measures of medication adherence and persistence are important for researchers and policymakers to assess quality of care. Lack of adherence has been associated with adverse outcomes and higher costs of care. Long-acting medication formulations, including injectable forms, have been proposed as interventions to increase adherence and in turn improve health outcomes and costs. Standard measures of adherence/persistence were developed for orally administered medications. Methods for assessing adherence/persistence of long-acting injectable dose forms are understudied.

OBJECTIVE

To compare the consistency between standard measures of adherence/persistence versus proposed variations that consider the data quality and injectable administration method for a long-acting injectable second-generation antipsychotic (SGA) using an orally administered SGA as the reference.

METHODS

Standard adherence/persistence measures were designed for oral tablet formulations, in particular accounting for accumulation of pills caused by early refills. To address this limitation and the accuracy of the days supply field for long-acting injectable SGAs in pharmacy claims, 2 alternatives are proposed. The first approach calculates days supply using the labeled dosing schedule for the given injectable. The second approach builds on the first and sets days supply to the minimum of the time between injections and the time frame according to the labeled dosing schedule. Administrative health care claims data from the Missouri Medicaid system were analyzed to compare adherence/persistence measures between formulations. Common adherence/persistence measures, including medication possession ratio (MPR) and proportion of days covered (PDC), were evaluated in this study. The analysis cohorts comprised 195 adult patients with schizophrenia who initiated a long-acting injectable SGA (LA-SGA) and 369 patients initiating an oral SGA (O-SGA) from August 1, 2009, through April 30, 2010. Chi-squared tests, the Kruskal-Wallis test, and Kaplan-Meier curves were used to compare adherence/persistence measures between cohorts.

RESULTS

Days supply was most frequently recorded as 30 days for O-SGA and 28 days for LA-SGA. Time between claim fills was most commonly 28 days for both cohorts. Using the LA-SGA pharmacy claims data, MPR was 0.91 and did not vary significantly from MPR of O-SGA (0.90; test statistic = 0.29, P = 0.590). When applying the labeled dosing schedule to compute days supply, the LA-SGA MPR rose to 0.97 and varied significantly from MPR of O-SGA (test statistic = 9.60, P = 0.002). Additionally controlling for the inability for excess medication accumulation, MPR for LA-SGA dropped to 0.86, which varied significantly from MPR of O-SGA (test statistic = 4.01, P = 0.045). PDC varied from 0.55 to 0.61 for LA-SGA but was consistently significantly different from the 0.37 PDC value of O-SGA (P  less than  0.05 for each comparison).

CONCLUSIONS

Standard medication adherence/persistence measures yielded different conclusions when comparing a LA-SGA and an O-SGA, depending on the measure and underlying assumption for days supply. Adherence/persistence measures that address pharmacological differences in terms of formulation and duration of therapeutic drug levels between medications may be necessary and are particularly important as more injectable antipsychotic medications are approved in the United States. Therefore, payers and investigators should consider sensitivity analysis using different adherence/persistence definitions when making product comparisons to ensure confidence in conclusions.

摘要

背景

衡量药物依从性和持久性对于研究人员和政策制定者评估医疗质量非常重要。缺乏依从性与不良后果和更高的医疗成本有关。长效药物制剂,包括注射形式,已被提议作为增加依从性的干预措施,从而改善健康结果和成本。口服药物的依从性/持久性标准已经制定。长效注射剂型的依从性/持久性评估方法研究不足。

目的

比较标准的依从性/持久性测量方法与提出的变化,这些变化考虑了第二代长效抗精神病药(SGA)的长效注射剂型的药物质量和注射管理方法,以口服 SGA 作为参考。

方法

为口服片剂制剂设计了标准的依从性/持久性测量方法,特别是考虑了早期补充导致的药丸积累。为了解决这个限制和长效注射 SGA 在药房索赔中天数供应字段的准确性,提出了 2 种替代方案。第一种方法使用给定注射剂的标签剂量方案计算天数供应。第二种方法基于第一种方法,并将天数供应设置为注射间隔和标签剂量方案规定的时间框架之间的最小值。分析使用密苏里州医疗补助系统的行政医疗保健索赔数据,比较不同制剂的依从性/持久性测量方法。本研究评估了常见的依从性/持久性测量方法,包括药物持有率(MPR)和覆盖率(PDC)。分析队列包括 195 名成年精神分裂症患者,他们开始使用长效注射 SGA(LA-SGA)和 369 名开始使用口服 SGA(O-SGA)的患者,起始日期为 2009 年 8 月 1 日至 2010 年 4 月 30 日。使用卡方检验、克鲁斯卡尔-沃利斯检验和 Kaplan-Meier 曲线比较队列之间的依从性/持久性测量方法。

结果

O-SGA 的天数供应最常记录为 30 天,LA-SGA 的天数供应最常记录为 28 天。两次索赔之间的时间间隔最常见的是 28 天,两个队列都是如此。使用 LA-SGA 药房索赔数据,MPR 为 0.91,与 O-SGA 的 MPR(0.90)没有显著差异(检验统计量=0.29,P=0.590)。当应用标签剂量方案计算天数供应时,LA-SGA 的 MPR 上升至 0.97,与 O-SGA 的 MPR 有显著差异(检验统计量=9.60,P=0.002)。此外,考虑到过量药物积累的能力不足,LA-SGA 的 MPR 下降至 0.86,与 O-SGA 的 MPR 有显著差异(检验统计量=4.01,P=0.045)。LA-SGA 的 PDC 从 0.55 到 0.61 不等,但始终与 O-SGA 的 0.37 PDC 值显著不同(每次比较的 P 值均小于 0.05)。

结论

当比较长效 SGA 和口服 SGA 时,基于药物的天数供应,标准的药物依从性/持久性测量方法得出了不同的结论。在考虑药物制剂和治疗药物水平持续时间方面的药理学差异的情况下,可能需要采用药物依从性/持久性测量方法,并且随着更多的长效抗精神病药物在美国获得批准,这些方法尤其重要。因此,在进行产品比较以确保结论的可信度时,支付方和研究人员应考虑使用不同的依从性/持久性定义进行敏感性分析。

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