Outcomes Scribe, LLC, Leawood, KS 66224, USA.
J Med Econ. 2013;16(3):397-406. doi: 10.3111/13696998.2013.764309. Epub 2013 Jan 22.
Treatment patterns for the MS disease-modifying therapies (DMT) have changed over time. The objective of this study was to examine and describe treatment patterns in MS over a 10-year period.
MS patients who filled a DMT prescription between January 1, 2001 and December 31, 2010 were identified from Clinformatics for DataMart affiliated with OptumInsight. Two cohorts were identified: those with a DMT prescription in 2003 and those with a DMT prescription in 2008. Treatment patterns were examined 2 years before and after the anchor prescriptions for each cohort.
Comparing treatment patterns prior to the two anchor prescriptions, interferon-beta (IFNβ)-1a IM (Avonex) and IFNβ-1b (Betaseron) gained the most users in 2001-2003, while IFNβ-1a IM and IFNβ-1a SC (Rebif) gained the most users from 2006-2008. In the 2 years following the two anchor prescriptions, treatment patterns changed. From 2003-2005, 21.2% of IFNβ-1a SC users and more than 15.0% of IFNβ-1a IM and IFNβ-1b users changed to another interferon or glatiramer acetate (GA; Copaxone), while 12.5% of GA users changed to an interferon, most often IFNβ-1a SC. From 2008-2010 the largest proportion of changes from each of the interferons and natalizumab (NZ; Tysabri) were to GA, while those switching from GA were most often changed to IFNβ-1a SC. Those with a 2008 anchor prescription for NZ were most often changed (57%) to GA.
In retrospective database analyses the presence of a claim for a filled prescription does not indicate that the drug was consumed, and reasons for changes in therapy are not available. The study design looking forward and backward from the anchor prescriptions may have contributed to differences in the proportion of patients seen with no observable change in DMT. Claims-based data are also constrained by coverage limitations that determine the data available and limit the generalizability of results to managed care patients.
Changes in treatment patterns in the first half of the observation period were reflective of the addition of IFNβ-1a SC to the market in 2002. Following the 2003 and 2008 anchor prescriptions there were differences in treatment patterns, with more IFNβ-1a IM users being changed to IFNβ-1a SC after the 2003 anchor DMT, and more of each of the interferons and NZ being changed to GA following the 2008 anchor DMT. With the introduction of oral therapies for MS, treatment patterns will again be impacted.
多发性硬化症（MS）疾病修饰疗法（DMT）的治疗模式随时间而变化。本研究的目的是在 10 年内检查和描述 MS 的治疗模式。
从 OptumInsight 下属的 Clinformatics for DataMart 中确定了 2001 年 1 月 1 日至 2010 年 12 月 31 日期间开具 DMT 处方的 MS 患者。确定了两个队列：2003 年开具 DMT 处方的队列和 2008 年开具 DMT 处方的队列。对每个队列的两个锚定处方之前和之后的治疗模式进行了检查。
在比较两个锚定处方之前的治疗模式时，2001-2003 年，干扰素-β-1a 肌内注射（Avonex）和干扰素-β-1b（Betaseron）获得了最多的使用者，而 2006-2008 年，干扰素-β-1a 肌内注射和干扰素-β-1a 皮下注射（Rebif）获得了最多的使用者。在两个锚定处方之后的两年内，治疗模式发生了变化。从 2003 年至 2005 年，21.2%的干扰素-β-1a 皮下注射使用者和超过 15.0%的干扰素-β-1a 肌内注射和干扰素-β-1b 使用者转为另一种干扰素或格拉替雷（Copaxone），而 12.5%的格拉替雷使用者转为干扰素，最常见的是干扰素-β-1a 皮下注射。从 2008 年至 2010 年，从每种干扰素和那他珠单抗（Tysabri）转为格拉替雷的比例最大，而从格拉替雷转为干扰素-β-1a 皮下注射的比例最大。那些在 2008 年接受那他珠单抗治疗的患者中，有 57%最常转为格拉替雷。
在回顾性数据库分析中，有处方的索赔并不表示药物已被使用，也无法得知治疗变化的原因。从锚定处方向前和向后观察的研究设计可能导致观察到的 DMT 无变化的患者比例存在差异。基于索赔的数据也受到覆盖范围限制的限制，这些限制决定了可用的数据，并限制了结果在管理式医疗患者中的通用性。
在观察期的前半段，治疗模式的变化反映了 2002 年干扰素-β-1a 皮下注射的上市。在 2003 年和 2008 年的锚定处方之后，治疗模式存在差异，在 2003 年的锚定 DMT 之后，更多的干扰素-β-1a 肌内注射使用者转为干扰素-β-1a 皮下注射，而在 2008 年的锚定 DMT 之后，每种干扰素和那他珠单抗转为格拉替雷的比例更大。随着多发性硬化症口服治疗药物的问世，治疗模式将再次受到影响。
