Region to legislate on the matter, supporting the prescription of the biosimilar to the naive patient. The aim of this study was to evaluate the impact of cost-containment policies about biosimilars in Campania between 2009 and 2013. Methods: IMS Health regional database was used to carry out this descriptive retrospective drugutilization for the years 2009 through 2013. Information was retrieved about different distribution channels (retail, direct distribution, hospital). Consumptions are expressed in Counting Units (CU) and trends have been calculated using Compound Average Grow Rate (CAGR). Results: In 2013, a total consumption of 930.859 CU of biosimilar drugs was registered in Italy (CAGR 13/09 68,8%). The penetration rate of biosimilar was 23,9% with regard to expenditure and 25,3% with regard to consumption. Analyzing the consumption of biosimilars by therapeutic category in Italy, the consumption of erythropoietin and filgrastim has an index of annual growth respectively equal to 153.4% and 174.7%. In Campania, the penetration rate of all biosimilars was 31.4% of total expenditure and 35.9% of consumption. Analyzing the trend in consumption for single therapeutic category, it can be seen that penetration is due to erythropoietin (297.5% CAGR); with regard to filgrastim, however, the average annual growth rate is around 54%. ConClusions: The results suggest that Campania Region records an index of market penetration of biosimilars higher than the national. This trend could be attributable to the cost-containment policies implemented in the region.

Objectives: Chronic idiopathic (or spontaneous) urticaria (CIU) is estimated to occur in 0.3% of the general population in Turkey. Although the burden of the disease is substantial for the payer, there has been no cost-analysis performed in our country. The purposes of this study are to determine the resources and costs related to the diagnosis and treatment of patients with CIU, and to estimate the annual economic burden to the Social Security Institution (SGK). MethOds: Delphi technique was applied to determine the type and the amount of resources used in different stages of CIU defined as mild or moderate to severe based on physicians clinical assessment. The Delphi method solicits the opinion of an expert panel through a carefully designed questionnaire which in this case included questions on: epidemiology, diagnosis, treatment of symptoms and angioedema, adverse events, follow-up visits, hospital and emergency service admissions. The responses were analysed and discussed in a face to face meeting followed by consensus building steps. Unit of resources used for different CIU severity levels were determined from expert opinion. Unit costs of resources used in outpatient clinics were obtained from SGK's Reimbursement Guideline-List of Procedure Fees Per Service. Results: Hospitalizations, emergency admissions, outpatient visits and treatments, are the key cost drivers in the management of CIU The annual cost per patient is calculated to be 725.36 Turkish Liras (TL) for mild CIU, 1.322,61 TL for moderate CIU and 2,478.75 TL for severe CIU. The total annual cost of CIU to SGK is estimated to be 262 million TL in 2014. cOnclusiOns: This is the first study that aims to estimate the resource utilisation and cost burden of CIU in Turkey by using the Delphi technique. Cost effective treatment of CIU is an unmet need given the heavy burden to SGK identified by the Delphi Panel.

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A445 Objectives: Gemeinsame Bundesausschuss (G-BA) states that it assesses additional benefit strictly on clinical grounds, but it also requires that manufacturers submit drug and comparator costs. This raises the possibility that G-BA's assessment might be influenced by price, possibly to provide leverage during subsequent price negotiations. This research tests the hypothesis that high cost drugs (relative to the comparator) are more likely to receive poor benefit assessments. MethOds: The following variables were collected from the Federal Gazette publication or the "Beschluss" document: additional benefit assessment, annual cost per patient of drug and comparator, and estimated target population. The Scottish Medicines Consortium (SMC) clinical rationale for the same drugs and indications were collected to control for clinical efficacy. After excluding orphan drugs, reviews using best supportive care comparators, and reviews without SMC reviews, 58 reviews remained for analysis. G-BA's additional benefit assessments were ranked from least benefit to most. The influence of drug cost relative to the comparator on the G-BA assessment was estimated via an ordered logit model. The model also included controls for the (log) size of the target population and clinical efficacy (SMC's clinical assessment). Results: An increase in the cost difference between the drug and the comparator is estimated to result in a modest, statistically significant increase in the odds of receiving an additional benefit assessment greater than a "no additional benefit" assessment. cOnclusiOns: Our results are inconsistent with the alternative hypothesis that G-BA is strategically discounting its assessment of relatively high cost drugs. The positive estimated relationship is consistent with manufacturers' setting higher prices for more beneficial drugs (The data available provide no way to statistically account for this plausible source of endogeneity). Our results provide no support for rejecting the null hypothesis that G-BA assesses added benefit independently of drug cost.