PGI4 - Vedolizumab In Ulcerative Colitis; A Budget Impact Model for A Novel Drug In A Recession Environment

Abstract

Ulcerative Colitis (UC) exerts significant burden to IBD patients and payers. The aim of this study was to estimate the budget impact of vedolizumab in moderate/severe UC, from the perspective of the Greek healthcare setting. A Microsoft Excel-based budget impact model was adapted for a hypothetical cohort within the total Greek population of IBD patients with moderate/severe UC. The budget impact was calculated and presented as incremental drug-acquisition and administration costs (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 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. The increase in total costs from the introduction of vedolizumab and biosimilars to the Greek healthcare system, would be €255,926, €673,491 and €814,924 for the three respective years post-entry (cumulative €1,744,341). Average incremental per patient cost for the first year was found to be €249 when vedolizumab and biosimilars received 21% and 11% of total UC biologic volumes respectively. Yearly total pharmaceutical UC expenditure ranged from €2,735,702 to €3,016,905 in the absence of vedolizumab and €2,991,628 to €3,831,829 when vedolizumab was available with estimated expenditure on biosimilar therapies not exceeding €853,470 over three years. Irrespective of the limitations due to lack of country-specific data, vedolizumab introduction is not expected to exert significant pressure on third party pharmaceutical UC expenditure.