OBJECTIVES: Crohn’s disease (CD) exerts significant burden to IBD-patients and payers. The aim of this study was to estimate the budget impact of vedolizumab in moderate/severe CD, from the perspective of the Greek healthcare setting. METHODS: A Microsoft Excel-based budget impact model was adapted for a hypothetical cohort of IBD patients with moderate/severe CD within the total Greek population. The budget impact was calculated and presented as incremental drug-acquisition and administration costs, using input values obtained from National official databases, before and up to three years after the introduction of vedolizumab versus standard of care. Clinical efficacy and adverse event costs were not taken into consideration. The model also assumed reimbursement of infliximab-biosimilars in 2015 with low market-penetration and conventional treatment almost steady throughout the three-year time horizon. Input data for estimated volumes of vedolizumab and biosimilars were validated separately by two opinion leaders in gastroenterology from a tertiary public and a private hospital, with vedolizumab experience through early-access programs. Any assumptions that showed discrepancies to expert opinion were converted to the average value of the two inputs. Values are in €2015. RESULTS: The increase in total costs from the introduction of vedolizumab and infliximab-biosimilars to the Greek healthcare system, would be €195,600, €519,429 and €788,147 for the three respective years post-entry (cumulative €1,503,176). Average incremental per patient cost for the first year was found to be €164 when vedolizumab and biosimilars received 10.9% and 3.3% of total CD biologic volumes respectively. Yearly total pharmaceutical CD expenditure ranged from €5,024,036 to €5,653,930 in the absence of vedolizumab and €5,219,636 to €6,442,077 when vedolizumab was available with estimated expenditure on biosimilar therapies not exceeding €745,000 over three years.   CONCLUSIONS: Irrespective of the limitations due to lack of country-specific data, vedolizumab introduction is not expected to exert significant pressure on third party pharmaceutical CD expenditure.