OBJECTIVES: To investigate the pharmacoeconomic performance of the treatment with solifenacin, a bladder-selective muscarinic receptor antagonist, as compared to tolterodine and placebo, in Italian patients with overactive bladder (OAB). METHODS: A simple Markov model simulates 52-weeks clinical and economical outcomes associated with the treatment with solifenacin (5 mg/die), tolterodine ER (4 mg/die), and no treatment, in a cohort representative of the Italian OAB population, relying on RCT efficacy and national cost data, and using 1-week cycles. Only direct healthcare costs were considered.The main analysis is conducted from the point of view of the patient, as drugs for OAB are not currently reimbursed in Italy, whereas incontinence medical devices are only to few selected patients. A complementary scenario was elaborated to explore the consequences of a hypothetical reimbursement decision by the Italian NHS at half of the current retail price and only to incontinent and responding OAB patients. RESULTS: Both active treatments produce significant improvements in symptoms and quality of life, with an increase in costs of about €540 – 640 and €680 – 780/patient/year with solifenacin and tolterodine, respectively. Cost-utility analysis indicates that solifenacin dominates tolterodine and has an ICUR in the range €7,600 – 18,600/QALY compared to no treatment. In the subgroup of patients incontinent at baseline and who respond to the therapy, the increase in costs with solifenacin results in €100-400/patient/year.The expected incremental expenditure of the theoretical reimbursement decision is about €23 millions/year, with an ICUR of about €600 – 2,400/QALY. CONCLUSIONS:Solifenacin has the potential to improve current clinical outcomes of many Italian OAB patients, at a mean net cost of €540 – 640/year. The ICUR of the hypothesized reimbursement decision can expected to be very favourable.