[Not Available].

INTRODUCTION

: Intermittent catheterization is the standard of care for neurogenic bladder dysfunction; however, urinary tract infections (UTIs) remain a major clinical and economic complication in patients with multiple sclerosis (MS) or spinal cord injury (SCI). Micro-hole Zone Technology (MhZT), implemented in the Luja™ catheter, is designed to support bladder emptying.

METHODS

: A static 5-year budget impact model was developed from the perspective of the Italian National Health Service, assuming a stable eligible population and comparing a current scenario without Luja™ with progressive adoption from 5% to 25%. Direct medical costs of catheters and UTI management were included; no discounting was applied. Deterministic scenario analyses explored uncertainty in clinical effect, UTI costs and uptake.

RESULTS

: The eligible population included 64,600 users with SCI and 40,600 with MS. In patients with SCI, Luja™ adoption reduced cumulative 5-year expenditure from € 1,652.9 million to € 1,643.3 million, preventing 28,861 UTIs. In patients with MS, expenditure decreased from € 1,039.2 million to € 1,033.1 million, preventing 18,139 UTIs. Overall, the model estimated approximately 47,000 avoided UTIs and € 15.8 million in related savings.

CONCLUSIONS

: Under the model assumptions, gradual adoption of MhZT may be economically sustainable and potentially cost-saving for the Italian National Health Service. Results are mainly driven by an indirectly estimated reduction in UTIs and should be confirmed using comparative real-world evidence.