Cost-effective Uses of New Hepatitis C Treatments and their VA Budgetary Impact

新的丙型肝炎治疗方法的成本效益及其对 VA 预算的影响

• 批准号: 8473515
• 负责人: DOUGLAS K OWENS
• 金额: --
• 依托单位: VETERANS ADMIN PALO ALTO HEALTH CARE SYS
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-01 至 2015-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8473515
• 关键词: Adverse effects; Affect; Age; Ambulatory Care; Antiviral Agents; Budgets; Caring; Chronic; Chronic Hepatitis C; Cirrhosis; Clinical; Data; Data Set; Data Sources; Development; Disease; Drug usage; Expenditure; Future; Genotype; Goals; Health; Health Care Costs; Hepatitis C; Hepatitis C virus; Individual; Inpatients; Interferons; Interleukins; Laboratories; Life; Liver Fibrosis; Longitudinal Studies; Malignant neoplasm of liver; Medical; Modeling; Outcome; Patients; Patterns of Care; Pharmaceutical Preparations; Pharmacotherapy; Pharmacy facility; Phase III Clinical Trials; Policies; Population; Primary carcinoma of the liver cells; Procedures; Publishing; Regimen; Registries; Research; Research Personnel; Resources; Ribavirin; Services; Subgroup; System; Testing; Treatment Cost; Treatment Efficacy; Treatment Protocols; United States Food and Drug Administration; Veterans; Work; alternative treatment; base; care systems; clinical care; cost; cost effective; cost effectiveness; effective therapy; experience; health economics; improved; liver transplantation; mathematical model; meetings; mortality; multidisciplinary; outcome forecast; randomized trial; response; standard care; statistics; success; tool; treatment duration; treatment response; treatment strategy; uptake

DESCRIPTION (provided by applicant): The long-term goals of our research are to: 1) help VA clinicians improve outcomes for veterans with chronic, hepatitis C virus (HCV) infections using treatment regimens that may incorporate newly available, directly acting antivirals (DAA); 2) provide information to policymakers considering the benefits, harms, and costs associated with these and forthcoming new treatment regimens; and 3) conduct research that responds directly to the most pressing questions delineated by VA clinician and operational leaders regarding HCV. Chronic HCV is of particular concern to the VHA given that 147,000 veterans are infected, the condition is difficult and extremely costly to manage, and causes decompensated cirrhosis, hepatocellular carcinoma, and the need for liver transplantation. Standard two-drug HCV treatments are effective in a limited proportion of patients and can cause substantial side effects. When added to standard treatment, DAAs improve success rates but are also expensive and increase rates of serious side effects. VA has estimated the expenditures for DAAs and associated treatments could reach one billion dollars in fiscal year 2012. In addition, recent studies provide evidence that an individual's Interleukin 28B (IL-28B) genotype predicts response to HCV therapy and may prove useful in helping predict response to therapy. We aim to study the costs, cost-effectiveness, and budgetary impact of alternative treatment regimens including DAAs. Our study has three specific aims: 1. To characterize the treatment costs and utilization, care patterns, and patient attributes of the VHA HCV population. a. We will analyze laboratory and pharmacy data from the VA Clinical Case Registry of HCV care, VA administrative datasets, and service costs from the VA's Health Economics Resource Center. 2. To assess the cost-effectiveness of DAAs and IL-28B genotype testing in the VHA HCV population, and to develop an analytic framework for evaluating the cost-effectiveness of additional new treatments for HCV. a. We will develop a VHA-specific cost-effectiveness model to evaluate how alternative HCV treatment regimens, including the new DAAs, and any additional new HCV drugs approved during the project period, influence long-term outcomes, including mortality, decompensated cirrhosis, hepatocellular carcinoma, and liver transplantation. b. We will quantify differences in health improvements and changes in costs attributable to DAA and other new HCV drug use for subgroups of veterans defined in terms of combinations of age, extent of liver fibrosis, and IL-28B genotype. Subgroup differences may result from disease prognosis, other medical costs, and response to treatment which in turn may influence cost-effectiveness.. 3. To estimate the VA budget impact and resource requirements associated with uptake of the new treatment strategies. a. We will conduct budget impact and resource requirement analyses using the VHA-specific cost- effectiveness model and VA-specific inputs for uptake of new treatment regimens to assess all VA costs including inpatient care, outpatient care, including staffing, and pharmacy costs. We will develop a spreadsheet-based tool for direct use by VA policymakers to help them to anticipate and plan for the optimal roll-out and management of HCV treatments.

描述（由申请人提供）： 我们研究的长期目标是：1）帮助退伍军人管理局临床医生改善慢性丙型肝炎病毒（HCV）感染的退伍军人的治疗结果，使用可能包含新可用的直接作用的抗病毒药物（DAA）的治疗方案; 2）为政策制定者提供信息，考虑与这些和即将到来的新治疗方案相关的利益，危害和成本;和3）进行研究，直接回应最紧迫的问题，由VA临床医生和业务领导人划定有关丙型肝炎病毒。慢性HCV是VHA特别关注的问题，因为有147，000名退伍军人被感染，这种情况很难管理，成本极高，并导致失代偿性肝硬化，肝细胞癌和肝移植的需要。标准的两种药物HCV治疗在有限比例的患者中有效，并可能导致严重的副作用。当添加到标准治疗中时，DAA提高了成功率，但也很昂贵，并增加了严重副作用的发生率。VA估计，在2012财年，DAA和相关治疗的支出可能达到10亿美元。此外，最近的研究提供的证据表明，一个人的白细胞介素28 B（IL-28 B）基因型预测对HCV治疗的反应，并可能证明有助于预测治疗的反应。我们的目标是研究替代治疗方案（包括DAA）的成本、成本效益和预算影响。我们的研究有三个具体目标：1。描述VHA HCV人群的治疗费用和利用率、护理模式和患者属性。a.我们将分析来自VA HCV护理临床病例登记处的实验室和药房数据，VA管理数据集以及VA卫生经济学资源中心的服务成本。2.评估VHA HCV人群中DAA和IL-28 B基因型检测的成本效益，并制定一个分析框架，用于评估HCV额外新治疗的成本效益。a.我们将开发一个VHA特异性成本效益模型，以评估替代HCV治疗方案，包括新的DAA，以及项目期间批准的任何其他新的HCV药物，如何影响长期结局，包括死亡率，失代偿性肝硬化，肝细胞癌和肝移植。B.我们将量化DAA和其他新的HCV药物使用的退伍军人亚组的健康改善和成本变化的差异，这些亚组根据年龄，肝纤维化程度和IL-28 B基因型的组合来定义。亚组差异可能由疾病预后、其他医疗费用和对治疗的反应引起，而这些又可能影响成本效益。3.估计与采用新治疗策略相关的VA预算影响和资源需求。a.我们将使用VHA特定的成本效益模型和VA特定的投入进行预算影响和资源需求分析，以采用新的治疗方案，评估所有VA成本，包括住院治疗、门诊治疗（包括人员配备）和药房成本。我们将开发一个基于电子表格的工具，供VA政策制定者直接使用，以帮助他们预测和规划HCV治疗的最佳推出和管理。