■这项研究评估了resmetirom作为治疗成人非肝硬化非酒精性脂肪性肝炎(NASH)伴中度至晚期肝纤维化的预算影响,并估计了美国假设的私人付款人的总成本。
■为假设的100万成员私人健康计划开发了基于开放队列状态过渡模型的三年预算影响分析。比较器是护理标准(SOC),定义为非肝硬化NASH患者中晚期肝纤维化的常规护理。每一年,通过流行,事件,和诊断率估计。成本包括私人付款人的医疗和药房福利所产生的资源,包括雷斯梅特罗姆药物收购成本,诊断和监测,按疾病进展状态分层的其他医疗和其他处方费用(即,非肝硬化与肝硬化/晚期肝病)。将Resmetirom不良事件管理成本纳入敏感性分析。药物成本是根据截至2024年3月的平均批发采购成本估算的。其他费用基于已公布的资料来源,并膨胀至2023美元。预算影响结果汇总显示,net,并以每个成员每月(PMPM)为基础。
■与没有resmetirom的场景相比,瑞美特罗姆的引入产生了50至238名接受治疗的患者的结果,净预算影响为2.2至950万美元,在第一年和第三年,PMPM从0.19美元提高到0.80美元。不包括resmetirom的净成本随着时间的推移而下降。在敏感性分析中,结果对诊断和流行病学输入最敏感.
■市场份额基于内部预测,很短的时间范围,平均治疗效果,
■在非肝硬化NASH合并中度至晚期肝纤维化的处方集中采用resmetirom导致预算影响适度增加,与NASH进展相关的成本下降。
非酒精性脂肪性肝炎(NASH)是一种严重的肝脏疾病,可导致严重的肝脏损害,其他健康并发症,增加医疗费用。随着疾病的进展,患者通常经历恶化的健康结果。直到最近,在美国,没有食品和药物管理局(FDA)批准的NASH治疗方法.然而,2024年3月,FDA批准了REZDIFFRA™,一种专门设计用于治疗患有中度至晚期肝纤维化的NASH患者的新药(即,NASH伴有中度至晚期的肝脏瘢痕形成)。临床试验表明,REZDIFFRA™可以改善这些患者的健康结果。确定可从REZDIFFRA™获益的患者并估算相关费用,我们开发了一个预算影响模型。在这项研究中,我们详细介绍了该模型的发展,并介绍了其发现。我们的分析显示,虽然REZDIFFRA™与较高的总成本相关,主要是由于药物本身的价格,考虑到药物减缓疾病进展的能力,有潜在的成本节约。
UNASSIGNED: This study assessed the budget impact of resmetirom as a treatment for adults with non-cirrhotic non-alcoholic steatohepatitis (NASH) with moderate-to-advanced liver fibrosis and estimated total costs for a hypothetical private payer in the United States.
UNASSIGNED: A three-year budget impact analysis based on an open cohort state transition model was developed for a hypothetical one-million-member private health plan. The comparator was Standard of Care (SOC), defined as routine care for non-cirrhotic NASH patients with moderate-to-advanced liver fibrosis. Each year, the number of resmetirom treatment-eligible patients was estimated through prevalent, incident, and diagnostic rate estimates. Costs included resources incurred by the medical and pharmacy benefits of private payers, including resmetirom drug acquisition costs, diagnosis and monitoring, other medical and other prescription costs stratified by disease progression status (i.e. non-cirrhotic vs. cirrhotic/advanced liver diseases). Resmetirom adverse event management costs were included in sensitivity analysis. Drug costs were estimated based on the average wholesale acquisition cost as of March 2024. Other costs were based on published sources and inflated to 2023 US dollars. Budget impact outcomes were presented in aggregate, net, and on a per-member per-month (PMPM) basis.
UNASSIGNED: Compared with a scenario without resmetirom, the introduction of resmetirom yielded results ranging from 50 to 238 treated patients, net budget impact of $2.2 to $9.5 million, and PMPM from $0.19 to $0.80 over years one and three. Net costs excluding resmetirom declined over time. In sensitivity analyses, results were most sensitive to diagnostic and epidemiologic inputs.
UNASSIGNED: Market shares are based on internal forecasts, a short time horizon, average treatment effects, and other limitations common to BIMs.
UNASSIGNED: The adoption of resmetirom on the formulary for the treatment of non-cirrhotic NASH with moderate-to-advanced liver fibrosis resulted in a moderate increase in budget impact with declining costs related to NASH progression.
Non-alcoholic steatohepatitis (NASH) is a serious liver disease that can lead to significant liver damage, other health complications, and increased healthcare costs. As the disease progresses, patients typically experience worsening health outcomes. Until recently, there were no Food and Drug Administration (FDA) approved treatments for NASH in the United States. However, in March 2024, the FDA approved REZDIFFRA, a new drug specifically designed to treat NASH patients with moderate-to-advanced liver fibrosis (i.e. NASH with moderate-to-advanced scarring of the liver). Clinical trials have shown that REZDIFFRA can improve health outcomes in these patients.To identify patients who could benefit from REZDIFFRA and to estimate the associated costs, we developed a budget impact model. In this study, we detail the development of this model and present its findings. Our analysis revealed that, while REZDIFFRA is associated with higher overall costs, primarily due to the price of the drug itself, there are potential cost savings when considering the drug’s ability to slow disease progression.