OBJECTIVES:   Vinorelbine was not available in breast carcinoma treatment through the Croatian National Health Insurance (CNHI) Positive Drugs List (PDL) and the aim of our study was to analyse the possible financial impact of vinorelbine inclusion to the CNHI PDL. METHODS:  A specific clinical guideline for vinorelbine reimbursement through the CNHI PDL is proposed according to evidence-based medical criteria and the main international guidelines. We have developed the budget impact analysis (BIA) model and calculated the number of patients who will be treated with vinorelbine in three-years’ period after the reimbursement following the proposed clinical guideline. The share of vinorelbine has been estimated using market data and the price of vinorelbine has been calculated according to the Croatian MoH Pricing Ordinance. The total costs for CNHI has been calculated using a referent scenario (without vinorelbine) and a scenario with vinorelbine reimbursement. Monte Carlo simulation has been performed too. RESULTS:  The total number of patients who could be potential candidates for the vinorelbine treatment will be 200-300 per year. An average annual drug cost per patient is estimated at 628.50 USD. Monte Carlo simulation results in breast cancer treatment showed the cost of 1,010,000 USD per year in scenario without vinorelbine and declining costs in scenario with vinorelbine from 879,299 USD in the first year of treatment to 614,411 in the third year. The savings of vinorelbine introduction during the three-year period will be 791,286 USD. CONCLUSIONS:  The inclusion of vinorelbine to PDL, according to the reimbursement criteria, demonstrates a net reduction of budget expenditures for CNHI (savings) in the period of three years due to the effects of substitution of other cytostatic drugs with vinorelbine (only in the indication of breast cancer). Our study supports the usage of vinorelbine from the clinical and pharmacoeconomical aspect and it could give certain clinical benefits for these patients.