Carlo Lazzaro,1 Roberto Bordonaro,2 Francesco Cognetti,3 Alessandra Fabi,3 Sabino De Placido,4 Grazia Arpino,4 Paolo Marchetti,5 Andrea Botticelli,5 Paolo Pronzato,6 Elisa Martelli7 1Studio di Economia Sanitaria, Milan, Italy; 2Public Hospital Trust Garibaldi, Catania, Italy; 3Istituto dei Tumori Regina Elena, Rome, Italy; 4School of Medicine, Federico II University, Naples, Italy; 5Department of Medical Oncology, School of Medicine, Sapienza University Hospital, Rome, Italy; 6Istituto di Ricovero e Cura a Carattere Scientifico, Azienda Ospedaliera Universitaria San Martino – Isituto Scientifico Tumori, Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy; 7Health Economics and Outcomes Research, Celgene Srl, Milan, Italy Purpose: Paclitaxel albumin (nab-paclitaxel) is a nanoparticle albumin-bound paclitaxel formulation aimed at increasing therapeutic index in metastatic breast cancer. When compared to conventional paclitaxel, nab-paclitaxel has a reported longer time to progression, higher response, lower incidence of neutropenia, no need for premedication, shorter time of administration, and in pretreated metastatic breast cancer patients, extended overall survival. This study investigates the cost-effectiveness of nab-paclitaxel versus conventional paclitaxel for pretreated metastatic breast cancer patients in Italy. Materials and methods: A Markov model with progression-free, progressed, and dead states was developed to estimate costs, outcomes, and quality adjusted life years over 5 years from the Italian National Health Service viewpoint. Patients were assumed to receive nab-paclitaxel 260 mg/m2 three times weekly or conventional paclitaxel 175 mg/m2 three times weekly. Data on health care resource consumption was collected from a convenience sample of five Italian centers. Resources were valued at Euro (€) 2011. Published utility weights were applied to health states to estimate the impact of response, disease progression, and adverse events on quality adjusted life years. Three sensitivity analyses tested the robustness of the base case incremental cost-effectiveness ratio (ICER). Results and conclusion: Compared to conventional paclitaxel, nab-paclitaxel gains an extra 0.165 quality adjusted life years (0.265 life years saved) and incurs additional costs of €2506 per patient treated. This translates to an ICER of €15,189 (95% confidence interval: €11,891–€28,415). One-way sensitivity analysis underscores that ICER for nab-paclitaxel remains stable despite varying taxanes cost. Threshold analysis shows that ICER for nab-paclitaxel exceeds €40,000 only if cost per mg of conventional paclitaxel is set to zero. Probabilistic sensitivity analysis highlights that nab-paclitaxel has a 0.99 probability to be cost-effective for a threshold value of €40,000 and is the optimal alternative from a threshold value of €16,316 onwards. Based on these findings, nab-paclitaxel can be considered highly cost-effective when compared to the acceptability range for ICER proposed by the Italian Health Economics Association (€25,000–€40,000). Keywords: metastatic breast cancer, nab-paclitaxel, conventional paclitaxel, cost-effectiveness analysis, Italy