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

摘要 这是一份K01奖的申请表，授予该系助理教授Haesuk Park博士。 佛罗里达大学药学院的药学成果与政策。朴博士正在建立 作为一名年轻的卫生服务研究员，她从事病毒性肝炎和弱势人群卫生政策方面的研究。 这一K01奖项将为Park博士提供必要的支持，以实现以下目标：(1)获得 对丙型肝炎病毒(丙型肝炎病毒)感染相关的健康风险因素有深入的了解，并强调 物质使用障碍和人类免疫缺陷病毒(HIV)混合感染；(2)在以下方面接受强化培训 开发调查工具和进行调查研究；(3)进一步了解流行病学和 与医疗补助申请和登记数据的纵向分析有关的统计知识；和(4)获取 进一步的赠款写作技能和经验，导致在年终前提交R01补助金 支持期限。为了实现这些目标，Park博士组建了一个指导团队，由一名初级医生组成 导师，佛罗里达大学流行病学和内科教授罗伯特·L·库克博士，专家 关于药物使用和艾滋病毒感染，以及三位共同导师：大卫·L·纳尔逊博士，一位肝病专家 丙型肝炎病毒靶向治疗和联合治疗的有效性和安全性的临床研究 优先研究；阿尔穆特·G·温特斯坦博士，药物流行病学和疾病风险模型专家 使用索赔数据；以及杰夫·S·哈曼博士，他在医疗政策和医疗服务研究方面拥有专业知识 弱势群体。 尽管现在可以获得有效的丙型肝炎病毒疗法，但大多数州的医疗补助计划限制了对 新的丙型肝炎病毒疗法，适用于使用药物的人以及合并感染艾滋病毒的人。帕克医生的 目前的研究将集中在医疗补助事前授权政策对处方者实践的影响， 患者获得新的丙型肝炎病毒治疗方法的情况以及丙型肝炎病毒感染患者的临床结果 使用障碍和/或艾滋病毒混合感染。这项建议有三个具体目标：(1)了解医生的 治疗合并药物使用障碍和/或HIV感染的丙型肝炎病毒感染者的态度和做法 感染与医疗补助优先授权政策有关；(2)比较以下人群的治疗启动率 患者(I)单一感染丙型肝炎病毒并患有药物使用障碍，(Ii)单一感染丙型肝炎病毒但不使用药物 (3)丙型肝炎病毒/艾滋病毒合并感染药物使用障碍；(4)丙型肝炎病毒/艾滋病毒合并感染而没有 使用两个大州(佛罗里达州和德克萨斯州)的药物使用障碍医疗补助数据；以及(3)治疗的丙型肝炎 患者，我们将把患者的医疗补助数据集与丙型肝炎病毒目标登记数据联系起来，以检查患者遵守 抗病毒方案和持续病毒学应答(SVR)，并调查依从性和SVR是否 因药物使用障碍和/或艾滋病毒合并感染而有所缓解。Park博士将使用定性的(医生调查) 以及定量方法，包括将丙型肝炎病毒靶标登记与医疗补助数据联系起来。这项研究将 形成拟在R01中提出的准实验性纵向研究和患者调查的基础 在K奖结束前批准申请。

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.