Antonazzo Ippazio Cosimo, Girolomoni Giampiero, Patruno Cataldo, Langella Roberto, Ottobrino Veronica, Mantovani Lorenzo Giovanni, Cortesi Paolo Angelo
Research Centre on Public Health (CESP), University of Milano-Bicocca, Via Pergolesi 33, Monza, MB, Italy.
Laboratory of Public Health, IRCCS Istituto Auxologico Italiano, 20149, Milan, Italy.
Dermatol Ther (Heidelb). 2025 Jul 9. doi: 10.1007/s13555-025-01475-2.
Lebrikizumab is a novel monoclonal antibody that targets interleukin-13, a pivotal factor in atopic dermatitis (AD). Previous studies revealed a positive benefit-risk profile of lebrikizumab as treatment for patients with moderate-to-severe AD. In Italy, lebrikizumab has been approved and reimbursed as treatment for patients with severe AD (aged 12 years or older and with an Eczema Area and Severity Index (EASI) ≥ 24). However, data on economic impact of lebrikizumab in these subjects are still scarce. This study aimed to assess the budget impact of lebrikizumab in Italian patients with severe AD, according to Italian Medicine Agency (AIFA) reimbursement criteria, from the Italian National Healthcare System (NHS) perspective.
The budget impact analysis model was used to estimate the economic impact of lebrikizumab as treatment of patients with severe AD by comparing the total budget expenditure under two scenarios: scenario A, which includes the current standard of care with biologic agents (dupilumab and tralokinumab), and scenario B, which includes dupilumab and tralokinumab along with the introduction of lebrikizumab. The analysis was conducted by adopting the Italian NHS perspective and a 3-year time horizon. The clinical data input was based on published evidence, pivotal clinical trial, and expert opinion. Cost data was retrieved from the Italian tariff and literature. One-way sensitivity analysis was conducted to assess the robustness of the model.
The base case analysis, conducted over a 3-year period, estimated that the number of patients treated with lebrikizumab increased from 1198 in the first year to 5849 in the final year of the simulation. The adoption of lebrikizumab for patient treatment resulted in a cumulative cost-saving of €3.3 million in 3 years (€786 thousand in the first year, - €1.7 million in the second year, and - €2.4 in the last year). The number of patients potentially eligible to the treatment, the injection site reaction cost, and the injection site reaction rate were the main drivers of the findings.
The availability of lebrikizumab as treatment for patients with severe AD would result in cost savings for Italy. Given the paucity of economic data on lebrikizumab, new economic studies should be conducted to confirm these findings.
乌帕替尼是一种新型单克隆抗体，靶向白细胞介素-13，这是特应性皮炎（AD）的关键因子。先前的研究表明，乌帕替尼治疗中度至重度AD患者的效益风险比为阳性。在意大利，乌帕替尼已被批准用于治疗重度AD患者（年龄在12岁及以上，湿疹面积和严重程度指数（EASI）≥24），并已纳入医保报销范围。然而，关于乌帕替尼对这些患者经济影响的数据仍然很少。本研究旨在从意大利国家医疗保健系统（NHS）的角度，根据意大利药品管理局（AIFA）的报销标准，评估乌帕替尼对意大利重度AD患者的预算影响。
采用预算影响分析模型，通过比较两种情况下的总预算支出，评估乌帕替尼治疗重度AD患者的经济影响：情景A包括当前使用生物制剂（度普利尤单抗和曲罗芦单抗）的标准治疗方案；情景B包括度普利尤单抗、曲罗芦单抗以及引入乌帕替尼的治疗方案。分析采用意大利NHS的视角和3年的时间范围。临床数据输入基于已发表的证据、关键临床试验和专家意见。成本数据从意大利收费标准和文献中获取。进行单向敏感性分析以评估模型的稳健性。
在3年期间进行的基础病例分析估计，接受乌帕替尼治疗的患者数量从第一年的1198例增加到模拟最后一年的5849例。采用乌帕替尼治疗患者在3年内累计节省成本330万欧元（第一年节省78.6万欧元，第二年节省170万欧元，最后一年节省240万欧元）。潜在符合治疗条件的患者数量、注射部位反应成本和注射部位反应率是这些结果的主要驱动因素。
乌帕替尼可用于治疗重度AD患者，这将为意大利节省成本。鉴于乌帕替尼的经济数据较少，应开展新的经济研究以证实这些发现。
