Medicaid Prior Authorization Policies for Chronic Hepatitis C Treatment in Vulnerable Populations

摘要 这是一份K 01奖的申请书，申请人是海洋学系助理教授Haesuk Park博士。 药学成果与政策，佛罗里达大学药学院。朴医生正在建立 她本人是病毒性肝炎和弱势群体卫生政策方面的年轻卫生服务研究员。 该K 01奖项将为Park博士提供必要的支持，以实现以下目标：（1）获得 深入了解与丙型肝炎病毒（HCV）感染相关的健康危险因素，重点是 药物使用紊乱和人体免疫机能丧失病毒（艾滋病毒）合并感染;（2）接受下列方面强化培训 开发调查工具，开展调查研究;（3）进一步了解流行病学， 与医疗补助索赔和登记数据纵向分析相关的统计知识;以及（4）获得 进一步授予写作技能和经验，导致在年底前提交R 01赠款 支持期。为了实现这些目标，Park博士组建了一个由主要成员组成的指导团队。 导师，罗伯特·L.佛罗里达大学流行病学和内科学教授、专家库克 关于药物使用和艾滋病毒感染，以及三位共同导师：大卫L。纳尔逊是一位肝病学家， 新的HCV疗法（包括HCV-TARGET）的有效性和安全性的临床研究， 优先研究; Almut G.药物流行病学和疾病风险模型专家温特斯坦说， 使用索赔数据;和杰夫S.哈曼在卫生政策和卫生服务研究方面具有专长， 弱势群体。 尽管目前已有有效的HCV治疗方法，但大多数州的医疗补助计划限制了对HCV的使用。 新的HCV疗法，用于使用药物的人以及合并感染艾滋病毒的人。朴医生的 目前的研究将集中在医疗补助事先授权政策对处方者实践的影响， 患者获得新的HCV治疗，以及HCV感染患者的临床结局， 使用障碍和/或艾滋病毒合并感染。该建议有三个具体目标：（1）了解医生的 对治疗物质使用障碍和/或HIV共感染的HCV感染患者的态度和做法， 与医疗补助事先授权政策有关的感染;（2）比较 患者（i）HCV单一感染伴物质使用障碍，（ii）HCV单一感染不伴物质使用 （iii）HCV/HIV共感染，伴有物质使用障碍;和（iv）HCV/HIV共感染， 使用两个大州（佛罗里达和得克萨斯）Medicaid数据的物质使用障碍;和（3）治疗的HCV 患者，我们将把患者的医疗补助数据集与HCV-TARGET登记数据联系起来，以检查对 抗病毒方案和持续病毒学应答（SVR），并研究依从性和SVR是否 由物质使用障碍和/或HIV合并感染调节。Park医生将使用定性（医生调查） 定量方法包括HCV-TARGET注册与Medicaid数据的链接。这项研究将 形成拟在R 01中提出的准实验性纵向研究和患者调查的基础 在K奖结束前申请补助金。

ABSTRACT This is an application for a K01 award for Dr. Haesuk Park, Assistant Professor in the Department of Pharmaceutical Outcomes & Policy at University of Florida College of Pharmacy. Dr. Park is establishing herself as a young health services researcher in viral hepatitis and health policy for vulnerable populations. This K01 award will provide Dr. Park with the support necessary to accomplish the following goals: (1) gain a solid understanding of health risk factors related to hepatitis C virus (HCV) infection with emphasis on substance use disorder and human immunodeficiency virus (HIV) co-infection; (2) obtain intensive training in the development of survey instruments and conducting survey research; (3) gain further epidemiology and statistical knowledge relevant to longitudinal analysis of Medicaid claims and registry data; and (4) acquire further grant writing skills and experiences, resulting in the submission of a R01 grant before the end of the support period. To achieve these goals, Dr. Park has assembled a mentoring team comprised of a primary mentor, Dr. Robert L. Cook, Professor of Epidemiology and Internal Medicine at University of Florida, an expert on substance use and HIV infection, and three co-mentors: Dr. David L. Nelson, a hepatologist who conducts clinical investigations in effectiveness and safety of new HCV therapies including HCV-TARGET and PRIORITIZE study; Dr. Almut G. Winterstein, an expert on pharmacoepidemiology and disease risk models using claims data; and Dr. Jeff S. Harman, who has expertise in health policy and health services research in vulnerable populations. Despite effective HCV therapies now available, a majority of state Medicaid programs restrict access to new HCV therapy for persons who use substances as well as individuals co-infected with HIV. Dr. Park's current research will focus on the impact of Medicaid prior authorization policies on prescribers' practices, patient's access to the new HCV therapies, and the clinical outcomes in HCV-infected patients with substance use disorder and or HIV co-infection. This proposal has three specific aims: (1) to understand physicians' attitudes and practices toward treating HCV-infected patients with substance use disorder and/or HIV co- infection in relation to Medicaid prior authorization policies; (2) to compare treatment initiation rates among patients (i) HCV mono-infected with substance use disorder, (ii) HCV mono-infected without substance use disorder; (iii) HCV/HIV co-infected with substance use disorder; and (iv) HCV/HIV co-infected without substance use disorder using two large states (Florida and Texas) Medicaid data; and (3) for treated HCV patients, we will link the Medicaid dataset of patients with HCV-TARGET registry data to examine adherence to antiviral regimes and sustained virologic response (SVR) and investigate whether adherence and SVR are moderated by substance use disorders and/or HIV co-infection. Dr. Park will use qualitative (physician survey) and quantitative methods including linking of HCV-TARGET registry with Medicaid data. This research will form the basis for a quasi-experimental longitudinal study as well as patient survey, to be proposed in an R01 grant application before the end of the K award.