ORGANIZATION The Pharmacy and Therapeutic Committee of the Veneto Region, Italy, is a regulating body responsible for the definition of the Regional Hospital Formulary in Veneto. Veneto comprised a territory of 4.800.000 inhabitants in the north-east part of Italy. The Unit for the Evaluation of Drug Efficacy (Unità di Valutazione dell'Efficacia del Farmaco, UVEF) is the technical group responsible for the evaluation reports of new drugs to be submitted to the Committee. The Committee evaluates the introduction of new technologies based on relevant information from the literature regarding: efficacy, safety and cost. Cost data are based on the acquisition cost of the new drugs and the alternatives already included in the formulary. The HTA reports contain the following relevant sections: general information; alternative treatments and insights from existing guidelines; efficacy and safety data; other HTA reports; pharmacoeconomics data from the literature; comparative drug costs. PROBLEM OR ISSUE ADDRESSED In 2008, four new indications for bevacizumab were approved by the National Drug Agency: 1) metastatic colon-rectal cancer in association with fluoropirimidines; 2) in combination with interferon alfa-2a for the first line treatment of patients with advanced and/or metastatic renal cell cancer; 3) in combination with paclitaxel as first line treatment in metastatic breast cancer; 4) in addition to platinum-based chemotherapy for the first-line treatment of patients with unresectable advanced, metastatic or recurrent non-small-cell lung cancer (other than predominantly squamous cell histology). Due to rising cost for oncological drugs in the region (total expenditure for 2007 Euro 151.001.736), the Committee put particular attention to the introduction of new oncological drugs in the formulary. GOALS as in all the evaluations made by the committee, the goal was to perform an evaluation process taking into account all the relevant information on efficacy, safety and costs data, in order to include in the formulary the indications with a favourable benefit/risk and benefit/cost profile. OUTCOMES ITEMS USED IN THE DECISION The following information were part of the evaluation: efficacy data from main clinical trials (phase II and III), published in full and reported in the EMEA assessment report; safety data from the same sources; considerations on safety, efficacy and cost by the main regulatory and HTA agencies in Europe (e.g., Scottish Medicine Consortium, NICE, HAS France); relevant organizational and cost issues arising from published pharmacoeconomic studies, when applicable; comparative drug costs in relation with alternatives already present in the regional formulary. IMPLEMENTATION STRATEGY based on the produced evaluations, the following were the considerations that brought to the Committee's decisions: 1) metastatic colon-rectal cancer: efficacy data on second-line treatment demonstrate a significant improvement in median overall and disease free survival; efficacy data on first-line treatment were less robust, with an increase in disease free survival of one month. In the last case the Committee did not include the drug in the formulary 2) renal cancer: the Committee considered the unfavourable safety profile of the drug, the less accepted route of administration (ev instead than oral sunitinib in first line treatment and sorafenib in second line), the need of a concomitant administration of interferon; the higher cost of the new regimen. Based on these factors, the Committee did not include the new indication in the formulary 3) breast cancer: based on the efficacy data, which demonstrated almost a double progression free survival, and a strict correlation between progression free survival and overall survival, the Committee approved the indication 4) non small cell lung cancer: the Commission analized the efficacy data and pointed out that the positive results were obtained in association with carboplatin and paclitaxel. The indication was included in the formulary with a limitation in association with these two drugs. RESULTS these decisions have been implemented and hospitals in the region are actually using the drug according to the restrictions. In parallel, a national registry by the Italian Regulatory Agency on Drugs had been set up. From the registry, it will be possible to perform a qualitative analysis on the usage, and on the indications and patient's outcomes. LESSONS LEARNED In the evaluation process, the decision is mainly taken based on the results on efficacy and safety from the published clinical trials. Other countries regulatory agencies opinions are considered, while published cost effectiveness data conducted in different settings are often useless for taking decisions at local level, due to lack of transferability of the chosen models and/or the different cost and organizational data.