OBJECTIVES: Hormone refractory prostate cancer has generally poor prognosis with an expected median survival of approximately 12 months. Cabazitaxel is an antineoplastic agent, recommended by NCCN guidelines in metastatic, hormone-resistant patients, after docetaxel therapy. Available alternatives are: mitoxantrone, a second docetaxel-containing regimen and other rescue chemotherapies. Although in Italy an official cost-effectiveness threshold value is not identified, the Italian Association of Health Economics (AIES) identifies a range from € 25.000 to € 40.000/QALY or LYG. The objective of the study is to evaluate the cost-effectiveness of cabazitaxel versus mitoxantrone in the Regional Health Service (RHS). METHODS: Survival data from the TROPIC trial were used to calculate the Incremental cost-effectiveness Ratio (ICER). The maximum hospital wholesale price allowable for Cabazitaxel and regional tender price for mitoxantrone were used to calculate costs of treatment (e.g. 6 cycles every 3 weeks). The perspective was RHS’s. It was decided to develop a conservative analysis and to quantify only the cost of drugs, as other direct costs (i.e. staff, premedication, managing adverse events) were not quantifiable or highly variable. The cost of drug administration was not considered, since it was the same for both drugs. RESULTS: Therapy with cabazitaxel versus mitoxantrone leads to an increase of the survival (+ 0.20/years) and an increase of costs (+ €18.785). The ICER is € 93.925/LYG. CONCLUSIONS: The estimated ICER is similar to what is shown in the more complete analysis of the National Institute for Health and Clinical Excellence and the Scottish Medicines Consortium. Moreover, the analysis was conservative because cabazitaxel showed more adverse events than mitoxantrone. If quantified, the ICER would have been higher. The Pharmacy and Therapeutic Committee of the Veneto Region expressed a negative opinion to the inclusion of the drug in the Regional Drug Hospital Formulary.