Background

Trials have demonstrated that proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are effective as an adjunct to statin therapy, but access and cost issues have limited their use in community practice.

Objective

The aim of the study was to better understand patients’ experiences when trying to obtain, fill, and use PCSK9 inhibitor therapy in community practice.

Methods

We conducted a patient survey to evaluate patient experiences with PCSK9 inhibitors including medication initiation, indication for treatment, insurance approval status, medication persistence, and reason for discontinuation. The survey was emailed to 4740 adults who used a patient access support program.

Results

Overall, 1327 of 4740 adults completed the survey (28.0% response rate). Of those, 75.0% were aged >60 years, 52.8% were male, and 92.4% were White. At the time of PCSK9 inhibitor prescription, 70.2% were not on a statin (with 84.4% of those not on a statin reporting statin intolerance). Overall, 74.6% of patients found the drug approval process to be “somewhat” or “very” burdensome. Among n = 1216 patients who initiated treatment, 33.7% discontinued by the time of the survey, with 50.0% taking the drug for 1 to 6 months. Patient out-of-pocket costs were the leading reported reason for discontinuation.

Conclusions

Most PCSK9 inhibitor users in community practice were not on a statin, presumably because of statin intolerance. The drug approval process and costs continue to be strong reasons for lower initiation of PCSK9 agents, as well as higher discontinuation rates.

中文翻译：

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患者在社区实践中使用前蛋白转化酶枯草杆菌蛋白酶/kexin 9 型抑制剂的历程。

 背景

试验表明，前蛋白转化酶枯草杆菌蛋白酶/kexin 9 型 (PCSK9) 抑制剂作为他汀类药物治疗的辅助药物是有效的，但获取和成本问题限制了它们在社区实践中的使用。

 客观的

该研究的目的是更好地了解患者在社区实践中尝试获得、补充和使用 PCSK9 抑制剂治疗时的经历。

 方法

我们进行了一项患者调查，以评估患者使用 PCSK9 抑制剂的体验，包括开始用药、治疗指征、保险审批状态、用药持续性和停药原因。该调查通过电子邮件发送给使用患者访问支持计划的 4740 名成年人。

 结果

总体而言，4740 名成年人中有 1327 人完成了调查（回复率为 28.0%）。其中，75.0% 的年龄为 >60 岁，52.8% 为男性，92.4% 为白人。在开具 PCSK9 抑制剂处方时，70.2% 的人未服用他汀类药物（其中 84.4% 的未服用他汀类药物的人报告他汀类药物不耐受）。总体而言，74.6% 的患者认为药物审批过程“有些”或“非常”繁琐。在 1216 名开始治疗的患者中，截至调查时，33.7% 的患者停药，其中 50.0% 的患者服用药物 1 至 6 个月。患者自付费用是停药的主要原因。

 结论

大多数社区实践中的 PCSK9 抑制剂使用者并未服用他汀类药物，可能是因为他汀类药物不耐受。药物审批流程和成本仍然是 PCSK9 药物启动率较低以及停药率较高的重要原因。