The first biosimilar monoclonal antibody (infliximab, CT-P13) was registered by the European Medicines Agency in 2013 for the treatment of several inflammatory conditions including rheumatoid arthritis (RA). Biosimilar infliximab is first being marketed in the Central and Eastern European countries. This paper presents the estimated budget impact of the introduction of biosimilar infliximab in RA over a 3-year time period in six selected countries, namely Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia. A prevalence-based model was constructed for budget impact analysis. Two scenarios were compared to the reference scenario (RSc) where no biosimilar infliximab is available: biosimilar scenario 1 (BSc1), where interchanging the originator infliximab with biosimilar infliximab is disallowed, and only patients who start new biological therapy are allowed to use biosimilar infliximab; as well as biosimilar scenario 2 (BSc2), where interchanging the originator infliximab with biosimilar infliximab is allowed, and 80 % of patients treated with originator infliximab are interchanged to biosimilar infliximab. Compared to the RSc, the net savings are estimated to be €15.3 or €20.8 M in BSc1 and BSc2, respectively, over the 3 years. If budget savings were spent on reimbursement of additional biosimilar infliximab treatment, approximately 1,200 or 1,800 more patients could be treated in the six countries within 3 years in the two biosimilar scenarios, respectively. The actual saving is most sensitive to the assumption of the acquisition cost of the biosimilar drug and to the initial number of patients treated with biological therapy. The study focused on one indication (RA) and demonstrated that the introduction of biosimilar infliximab can lead to substantial budget savings in health care budgets. Further savings are expected for other indications where biosimilar medicines are implemented.

11 Background There is a growing interest in policy making 12 for using utility measures and identifying algorithms to 13 convert disease-specific measures into utilities. 14 Objectives To analyse the relationship between EQ-5D, 15 Dermatology Life Quality Index (DLQI) and Psoriasis 16 Area and Severity Index (PASI) in psoriasis. To transform 17 DLQI scores, and key clinical, demographic and health 18 service utilisation variables into utilities. 19 Methods A cross-sectional questionnaire survey of 200 20 consecutive adult patients with moderate to severe psoria-21 sis was carried out in two Hungarian university clinics. The 22 relationship between the outcome measures were analysed 23 with correlations and with the known-groups method. 24 Bivariate and multivariate regression algorithms on EQ-5D 25 scores were formulated. 26Results The mean age of respondents was 51 years 27 (SD = 12.9), 68.5 % were male, and 51.5 % received 28 biological therapy. Median EQ-5D, DLQI, and PASI scores 29 were 0.73, 3.0, and 3.45, respectively. EQ-5D showed a 30 moderate correlation with the DLQI and with the PASI 31 (r s = -0.48 and -0.43, p \ 0.05). Strong correlation was 32 found between DLQI and PASI (r s = 0.81, p \ 0.05). 33 DLQI and PASI discriminated better among groups cate-34 gorised by the localisation of the lesions than EQ-5D.

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10 Background Despite the widespread availability of bio-11 logical drugs in psoriasis, there is a shortage of disease 12 burden studies. 13 Objectives To assess the cost-of-illness and quality of 14 life of patients with moderate to severe psoriasis in 15 Hungary. 16 Methods Consecutive patients with Psoriasis Area and 17 Severity Index (PASI) [ 10 and Dermatology Life Quality 18 Index (DLQI) [ 10, or treated with traditional systemic 19 (TST) or biological systemic treatment (BST) were inclu-20 ded. Demographic data, clinical characteristics, psoriasis 21 related medication, health care utilizations and employ-22 ment status in the previous 12 months were recorded. 23 Costing was performed from the societal perspective 24 applying the human capital approach. Quality of life was 25 assessed using DLQI and EQ-5D measures. 26 Results Two-hundred patients were involved (females 27 32 %) with a mean age of 51 (SD 13) years, 103 (52 %) 28 patients were on BST. Mean PASI, DLQI and EQ-5D 29 scores were 8 (SD 10), 6 (SD 7) and 0.69 (SD 0.3), 30 respectively. The mean total cost was €9,254/patient/year 31 (SD 8,502) with direct costs accounting for 86 %. The 32 main cost driver was BST (mean €7,339/patient/year).

Our findings highlight the importance of exploring expectations that might help to increase patients' compliance.