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芳香化酶抑制剂对乳腺癌患者起始、依从性和持续性的影响:应用多状态模型了解依从性的动态变化。

The impact of generic aromatase inhibitors on initiation, adherence, and persistence among women with breast cancer: Applying multi-state models to understand the dynamics of adherence.

机构信息

Department of Clinical Sciences, School of Pharmacy, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.

Cancer Center, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.

出版信息

Pharmacoepidemiol Drug Saf. 2020 May;29(5):550-557. doi: 10.1002/pds.4995. Epub 2020 Mar 20.

DOI:10.1002/pds.4995
PMID:32196839
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11363905/
Abstract

PURPOSE

Clinical trials have clearly documented the survival benefit of aromatase inhibitors (AIs); however, many women fail to initiate (primary nonadherence) or remain adherent to AIs (secondary nonadherence). Prior studies have found that costs impact secondary nonadherence to medications but have failed to examine primary nonadherence. The purpose of this study is to examine primary and secondary adherence following the reduction in copays due to the introduction of generic AIs.

METHODS

Using Surveillance, Epidemiology, and End Results-Medicare data, we identified 50 054 women diagnosed with incident breast cancer between 2008 and 2013. We compare women whose copays would change and those whose would not, due to the receipt of cost-sharing subsidies before and after generics were introduced using a difference-in-difference (DinD) analysis. To examine primary and secondary nonadherence, we rely on a multistate model with four states (Not yet initiated, User, Not Using, and Death). We adjusted for baseline factors using inverse probability treatment weights and then simulated adherence for 36 months following diagnosis.

RESULTS

The generic introduction of AIs resulted in patients initiating AIs faster (DinD = -4.7%, 95%CI = -7.0, -2.3; patients not yet initiating treatment at 6-months), being more adherent (DinD ranging in absolute increase of 8.1%-10.4%) and being less likely to not be using the therapy (DinD range in absolute decrease of 1.2% at 6 months to 8.8% at 24 months) for women that do not receive a subsidy after generics were available.

CONCLUSIONS

Introduction of generic alternatives to AIs significantly reduced primary and secondary nonadherence.

摘要

目的

临床试验清楚地证明了芳香化酶抑制剂(AIs)的生存获益;然而,许多女性未能开始(原发性不依从)或继续坚持使用 AIs(继发性不依从)。先前的研究发现,成本会影响药物的继发性不依从,但未能检查原发性不依从。本研究的目的是研究由于引入仿制药导致 copay 减少后原发性和继发性依从性。

方法

使用监测、流行病学和最终结果-医疗保险数据,我们确定了 50054 名在 2008 年至 2013 年间被诊断患有乳腺癌的女性。我们通过差异分析(DinD)比较了那些 copay 会因接受成本分担补贴而改变的女性和那些 copay 不会改变的女性,这些女性因在引入仿制药前后接受了成本分担补贴。为了检查原发性和继发性不依从,我们依赖于一个具有四个状态的多状态模型(尚未开始、使用者、未使用和死亡)。我们使用逆概率治疗权重调整了基线因素,然后模拟了诊断后 36 个月的依从性。

结果

AIs 的仿制药引入使患者更快地开始使用 AIs(DinD = -4.7%,95%CI = -7.0,-2.3;6 个月时未开始治疗的患者),依从性更高(DinD 绝对增加 8.1%-10.4%),并且不太可能不使用该疗法(DinD 绝对减少 1.2%在 6 个月至 24 个月时为 8.8%)对于在仿制药可用后不接受补贴的女性。

结论

仿制药替代 AIs 的引入显著降低了原发性和继发性不依从性。

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