Budget Impact Analysis of Lebrikizumab for Treating Severe Atopic Dermatitis.

Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Conclusion: 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.