Using a tool named cost-utility analysis, this study investigated whether rehabilitation combined with a given drug (abobotulinumtoxinA) for post-stroke spasticity is cost-effective (i.e. affordable) vs rehabilitation alone for both the Italian National Health Service and society. Over a period of 2 years, this study shows that each additional year weighted for health-related quality of life (quality-adjusted life year; QALY) gained via rehabilitation combined with abobotulinumtoxinA vs rehabilitation alone for post-stroke spasticity costs the Italian National Health Service and society €12,341 and €23,601, respectively (2018 values). Given the Italian informal acceptability range (i.e. the maximum amount decisionmakers are supposed to pay) for additional QALY gained (€25,000-40,000), these results support the conclusion that rehabilitation combined with abobotulinumtoxinA is a cost-effective (i.e. good value for money) healthcare programme for treating patients with post-stroke spasticity in Italy. Objective: To investigate costs and quality-adjusted life years of rehabilitation combined with abobotuli-numtoxinA (aboBoNT-A) (rehab/aboBoNT-A) vs rehabilitation alone (rehab) in post-stroke spasticity in Italy. Design: Based on both Italian National Health Service and societal perspectives, a 2-year cost-utility analysis model was performed. Subject/patients: The cost-utility analysis model considered hypothetical patients. Methods: The cost-utility analysis model was populated with data concerning demographics, disease severity, healthcare and non-healthcare resource consumption. Data were collected via a questionnaire administered to 3 highly experienced Italian physiatrists (864 out of 930 post-stroke spasticity patients on rehab/aboBoNT-A in total). Costs are expressed in Euro (€) based on the year 2018. Results: The cost to society (rounded to the nearest whole €) was €22,959 (rehab/aboBoNT-A) vs €11,866 (rehab). Italian National Health Servicefunded cost was €7,593 (rehab/aboBoNT-A) vs €1,793 (rehab). Over a period of 2 years rehab/ aboBoNT-A outperforms rehab in terms of qualityadjusted life years gained (1.620 vs 1.150). The incremental cost-utility ratio was €12,341 (Italian National Health Service viewpoint) and €23,601 (societal viewpoint). Sensitivity analyses confirmed the robustness of the baseline results.Conclusion: Despite some limitations, the higher number of quality-adjusted life years gained vs rehab and the high probability of reaching a cost-utility ratio lower than the Italian informal acceptability range (€25,000-40,000) make rehab/aboBoNT-A a cost-effective healthcare programme for treating patients with post-stroke spasticity in Italy.

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