Issue № 26 | 2016 (4)
Introduction. According to the current clinical recommendations, vedolizumab is one of the genetically engineered biological drugs recommended for the treatment of inflammatory bowel diseases, such as ulcerative colitis. It was recently registered in the Russian Federation. However, no studies on the economic substantiation of its use in patients with this disease in conditions of Russian health care system are available.
The aim of the study was to conduct a clinical and economic analysis of the use of vedolizumab in patients of 18 y. o. and older with moderate or severe active ulcerative colitis and unsatisfactory response, loss of response, or intolerance to one or several drugs in standard therapy, as well as inhibitors of tumor necrosis factor alpha (TNF-α).
Methods. A clinical and economic analysis of vedolizumab compared to a standard therapy and to infliximab (another biologic drug) was conducted from the perspective of the Russian health care system. It was performed in a global European pharmacoeconomic Markov model built for the UK and filled with Russian data, i. e. the results of clinical studies, literature data, and the results of an expert survey of professional gastroenterologists. The model considered the following types of the disease progression on the background of administered therapy: remission, mild, moderate, and severe stages of the disease, surgery, withdrawal due to adverse effects, and death. The outcomes in the models were assessed in two target groups: patients without previous administration of TNF-α inhibitors, and patients with no response or secondary loss of response to therapy with TNF-α inhibitors. Time horizon was 5 years, and therefore 5% discount factor was used for costs and outcomes. Finally values of incremental cost-effectiveness ratio (ICER) per life year and per quality-adjusted life year (QALY) were calculated.
Results of the clinical and economic study showed that the use of vedolizumab required additional costs compared to a standard therapy in patients with ulcerative colitis with ineffectiveness or intolerance of previous therapy. These costs were partly balanced by the reduction of medical costs connected with the type of disease progression and with the correction of adverse effects. Compared to the patients on standard therapy, patients who received vedolizumab had a longer remission stage, somewhat higher general survival rate, and lower need for surgery. Vedolizumab is a dominant alternative in patients with ulcerative colitis, who previously were not treated with TNF-α inhibitors, compared with original infliximab, because of lower costs and higher effectiveness. It is also a cost-effective technology compared to equal-share use of original and generic infliximab.
ulcerative colitis, vedolizumab, infliximab, clinical and economic analysis, cost-effectiveness analysis, cost-utility analysis.
Pyadushkina E. A. Clinical and Economic Analysis of the Use of Vedolizumab in Adult Patients with Ulcerative Colitis. Medical Technologies. Assessment and Choice. 2016; 4(26): 64–78.