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VA临床医生改善患有慢性，丙型肝炎病毒（HCV）感染的退伍军人的预后，使用治疗方案可能结合新可用的直接作用抗病毒药（DAA）； 2）向政策制定者提供信息，以考虑与这些新疗法相关的收益，危害和成本； 3）进行研究，直接回答了VA临床医生和运营领导者关于HCV的最紧迫的问题。鉴于147,000名退伍军人感染了147,000名退伍军人，这种情况很困难且昂贵，并且导致肝硬化，肝细胞癌以及对肝移植的需求，因此慢性HCV特别关注VHA。标准的两毒HCV治疗在有限的患者中有效，可能会引起实质性副作用。当添加到标准治疗中时，DAAS提高了成功率，但也很昂贵，并提高了严重副作用的速度。 VA估计了DAA和相关治疗的支出可能在2012财政年度达到10亿美元。此外，最近的研究提供了证据表明，个人的白介素28B（IL-28B）基因型基因型可以预测对HCV疗法的反应，并且可能证明有助于帮助预测治疗的反应。我们旨在研究包括DAA在内的替代治疗方案的成本，成本效益和预算影响。我们的研究具有三个具体的目的：1。表征VHA HCV人群的治疗成本和利用，护理模式和患者属性。一个。我们将分析来自HCV护理，VA行政数据集的VA临床案例注册中心的实验室和药房数据，以及VA的健康经济资源中心的服务成本。 2。评估VHA HCV人群中DAA和IL-28B基因型测试的成本效益，并开发一个分析框架来评估HCV其他新处理的成本效益。一个。我们将开发一个VHA特异性的成本效益模型，以评估包括新DAA在内的替代性HCV治疗方案以及在项目期间批准的任何其他新的HCV药物，会影响长期结局，包括死亡率，肝硬化，肝细胞癌癌和Liver liver移植。 b。我们将量化归因于DAA和其他新的HCV药物使用的健康改善和成本变化的差异，以根据年龄的组合，肝纤维化程度和IL-28B基因型定义的退伍军人亚组。亚组差异可能是由于疾病的预后，其他医疗费用以及对治疗的反应而导致的，这反过来可能会影响成本效益。3。估算与新治疗策略相关的VA预算影响和资源需求。一个。我们将使用VHA特定的成本效益模型和VA特异性投入进行预算影响和资源需求分析，以摄取新的治疗方案，以评估所有VA成本，包括住院护理，门诊护理，包括人员配备和药房成本。我们将开发一种基于电子表格的工具，用于直接使用VA政策制定者，以帮助他们预测和计划最佳的HCV处理和管理。