Department of Veterans Affairs, 3801 Miranda Ave. (132), Palo Alto, CA 94304.
J Manag Care Spec Pharm. 2014 Jun;20(6):533-40. doi: 10.18553/jmcp.2014.20.6.533.
The introduction of the first direct-acting antiviral agents (DAAs) for the treatment of hepatitis C virus (HCV), telaprevir and boceprevir, marked a unique event in which 2 disease-changing therapies received FDA approval at the same time. Comparative safety and effectiveness data in real-world populations upon which to make formulary decisions did not exist.
To describe the implementation, measurement, and outcomes of an enduring population-based approach of surveillance of medication management for HCV.
The foundation of the population approach to HCV medication management used by the Department of Veterans Affairs (VA) relied upon a basic framework of (a) providing data for effective regional and local management, (b) education and training, (c) real-time oversight and feedback from a higher organization level, and (d) prompt outcome sharing. These population-based processes spanned across the continuum of the direct-acting antiviral oversight process. We used the VA's HCV Clinical Case Registry-which includes pharmacy, laboratory, and diagnosis information for all HCV-infected veterans from all VA facilities-to assess DAA treatment eligibility, DAA uptake and timing, appropriate use of DAAs including HCV RNA monitoring and medication possession ratios (MPR), nonconcordance with guidance for adjunct erythropoiesis-stimulating agent (ESA) and granulocyte colony-stimulating factor (GCSF) use, hematologic adverse effects, discontinuation rates, and early and sustained virologic responses. Training impact was assessed via survey and change in pharmacist scope of practice.
One year after FDA approval, DAAs had been prescribed at 120 of 130 VA facilities. Over 680 VA providers participated in live educational training programs including 380 pharmacists, and pharmacists with a scope of practice for HCV increased from 59 to 110 pharmacists (86%). HCV RNA futility testing improved such that only 1%-3% of veterans did not have appropriate testing compared with 15%-17% 6 months earlier. By facility, the median proportion of veterans with MPR ≥ 0.95 remained 80% for those prescribed boceprevir; for telaprevir, the median proportion was 75% and improved to 80% 6 months later. Nonconcordance with VA medication guidance was as follows: receipt of an ESA without dose reducing ribavirin, 30% boceprevir, 45% telaprevir; ESA initiated with a hemoglobin greater than 10 g/dL, 42% boceprevir, 25% telaprevir; receipt of GCSF with absolute neutrophil count above the criteria threshold, 84%.
This clinically focused, comprehensive, population-based medication management approach affected real-time change in health services, practice, and outcomes evidenced by widespread and rapid DAA uptake, improved HCV RNA monitoring, attention to adherence, and more appropriate management of DAA-related anemia. Timely outcome sharing provided decision makers and clinicians evidence to support current HCV practices.
首批直接作用抗病毒药物（DAAs）用于治疗丙型肝炎病毒（HCV），特拉匹韦和博赛匹韦的获批，标志着 2 种改变疾病进程的疗法同时获得美国食品药品监督管理局（FDA）批准，这是一个独特的事件。然而，在制定医保目录时，我们没有关于这两种药物在真实世界人群中安全性和有效性的比较数据。
描述退伍军人事务部（VA）持续进行的基于人群的 HCV 药物管理监测方法的实施、测量和结果。
VA 采用的基于人群的 HCV 药物管理方法的基础是一个基本框架，包括：(a) 为有效的区域和本地管理提供数据；(b) 教育和培训；(c) 来自更高组织层面的实时监督和反馈；(d) 及时共享结果。这些基于人群的流程贯穿于直接作用抗病毒药物监测过程的始终。我们使用 VA 的 HCV 临床病例登记系统（该系统包含所有 VA 设施中所有 HCV 感染退伍军人的药房、实验室和诊断信息）来评估 DAA 治疗的适应证、DAA 的使用和时机、包括 HCV RNA 监测和药物暴露率（MPR）在内的 DAA 的合理使用、不遵循指南使用促红细胞生成素刺激剂（ESA）和粒细胞集落刺激因子（GCSF）的情况、血液学不良反应、停药率以及早期和持续的病毒学应答。通过调查和药剂师实践范围的变化来评估培训效果。
在 FDA 批准后 1 年，130 家 VA 机构中有 120 家提供了 DAA 治疗。超过 680 名 VA 提供者参加了现场教育培训项目，包括 380 名药剂师，接受 HCV 治疗的药剂师人数从 59 人增加到 110 人（86%）。HCV RNA 无效检测得到改善，只有 1%-3%的退伍军人未进行适当检测，而 6 个月前这一比例为 15%-17%。按机构划分，博赛匹韦组中 MPR≥0.95 的退伍军人比例中位数保持在 80%；而在接受特拉匹韦治疗的退伍军人中，这一比例中位数为 75%，6 个月后提高到 80%。VA 药物指南不相符的情况如下：接受 ESA 治疗而未减少利巴韦林剂量，博赛匹韦组为 30%，特拉匹韦组为 45%；ESA 治疗起始时血红蛋白大于 10 g/dL，博赛匹韦组为 42%，特拉匹韦组为 25%；GCSF 治疗时绝对中性粒细胞计数超过标准阈值，博赛匹韦组为 84%。
这种以临床为重点、全面的基于人群的药物管理方法影响了卫生服务、实践和结果的实时变化，其证据包括 DAA 的广泛和快速应用、HCV RNA 监测的改善、对依从性的关注以及 DAA 相关贫血的更合理管理。及时共享结果为决策者和临床医生提供了支持当前 HCV 治疗实践的证据。
