Budget Impact Analysis of Ublituximab as a Maintenance Treatment for Relapsing Multiple Sclerosis (RMS) in Spain

OBJECTIVES: RMS is a chronic disease with a substantial impact on patients' health-related quality of life and stands out as the leading cause of non-traumatic neurological disability in young adults. It is associated with a major clinical, social, and economic burden for patients, their families, and the National Healthcare System (NHS). New, highly effective therapeutic options that help the sustainability of the NHS are needed.

The objective of this study was to estimate the budget impact of ublituximab as an alternative to other high-efficacy therapies for the maintenance treatment of RMS adult patients from the Spanish NHS perspective.

METHODS: A budget Impact Model (BIM) with a 3-year time horizon was developed to study the impact of introducing ublituximab for the treatment of RMS. Ocrelizumab and ofatumumab, the currently available anti-CD20, were chosen as comparators. Only pharmacological costs were included. The posology was sourced from the corresponding Summary of Product Characteristics, and the unit cost from official databases. The public list price was used for all drugs. Market shares were estimated based on a market study.

RESULTS: The BIM revealed cost savings associated with ublituximab introduction in the NHS for RMS maintenance treatment. Savings steadily increased up to a total of 9.4 M cumulative over the 3-years’ time horizon. The sensitivity analysis confirmed the results' robustness, with the estimated target population being the main driver.

CONCLUSIONS: The potential reimbursement of ublituximab for the maintenance treatment of adult RMS patients could be associated with significant cost savings for the Spanish NHS, driven by the pharmacological costs savings. As a result, patient’s access to innovative and highly effective treatments would improve.

Disclaimer: This model was based on the Spanish list price; therefore, it reflects the budget impact of ublituximab vs. ocrelizumab and ofatumumab considering the drugs public prices and without considering any mandatory or confidential discounts.