Pharmacoeconomic analysis of subdermal tocilizumab in patients with rheumatoid arthritis

Rheumatoid arthritis (RA) is an autoimmune disease with unknown etiology that is characterized by chronic, erosive arthritis (synovitis), usually affecting more than five joints, and systemic impairment of internal organs. It usually leads to irreversible functional impairment of affected joints, and systemic inflammatory changes. The main goal of therapeutic strategies for RA focuses on preserving quality of life by suppressing the inflammation, preventing structural alteration of joints and other clinical manifestations, normalization of patient’s social functioning. Genetically engineered biological response modifi ers (GEBRM) are a class of drugs that allow the aforementioned results to be attained in patients who have not obtained the required clinical response from other therapeutic approaches. One of the modern GEBRM that have performed well in clinical trials is tocilizumab, which is available in both subcutaneous and intravenous formulation. Currently, not only clinical efficacy and safety, but also pharmacoeconomic expediency of a treatment regimen must be evaluated, which is the goal of current investigation. Aim. To assess the respective pharmacoeconomic performances of subcutaneous and intravenous forms of tocilizumab in Russian patients suff ering from RA. Methodology. A decision-tree model was constructed for this pharmacoeconomic analysis based on Russian healthcare standards and clinical practice. Each modelled group contained 1000 patients. The analysis was performed from the point of view of Russian healthcare system within context of Mandatory Medical Insurance system. Randomized controlled clinical trials investigating safety and effi cacy of analyzed drugs were used as source of efficacy and safety data. Time horizon of pharmacoeconomic analysis was set at 1 year. Clinical response per American college of rheumatology criteria and proportion of patients achieving remission or low activity of RA per DAS28 score were used as efficacy criteria. Safety criteria used were adverse event (AE) frequency and frequency of discontinuation due to AEs. Existing Russian RA treatment standard was used to calculate the healthcare resources utilization parameters. Modelling results were used to carry out Cost Minimization Analysis (CMA) and Budget Impact Analysis (BIA). Single-factor sensitivity analysis (SA) was used to ensure the results are robust to changes in market situation. Result. CMA factor has been determined to be -68 347 289 rubles in favor of subcutaneous tocilizumab, which indicates significant reduction of costs when using this drug form. Furthermore, BIA, when performed for 100 000 of Russian population indicates a 5.4% reduction of budgetary burden (which equals 17 155 170 rubles per 100 000 of population or 68 347 per patient). SA has proven that results are robust to price fl uctuations of up to 5%, which is a good result for a high-cost pharmaceutical. Conclusion. Use of subcutaneous form of tocilizumab results in cost reduction of 68 347 289 rubles, decreases the budgetary burden by 5,4% (17 155 170 rubles per 100 000 of Russian population). This indicates that use of subcutaneous tocilizumab for therapy of RA in Russian Federation is pharmacoeconomically justified.

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