Comparison of real costs in the French healthcare system in newly diagnosed patients with pemphigus for first-line treatment with rituximab vs. standard corticosteroid regimen: data from a national multicentre trial

Background Rituximab has been demonstrated to be highly effective as a first-line treatment for moderate-to-severe pemphigus; however, its high cost can be considered a limitation of this treatment. Objectives To compare direct costs of two regimens, rituximab + short-term prednisone vs. prednisone alone, tested in the Ritux3 trial. Methods Patients were randomly assigned to receive 2 g of rituximab and two 500-mg maintenance infusions at month 12 and month 18 along with low doses of prednisone for 3-6 months, or high doses of prednisone alone tapered over 12-18 months. We estimated the direct costs related to (i) protocol (treatments, consultations, hospitalizations); (ii) unfavourable disease course (relapse); and (iii) adverse events in both treatment groups during a 3-year follow-up. Results Annual individual cost discrepancies related to drugs decreased from +(sic)3597 to -(sic)1589 from the first to the third year, which corresponded to an initially higher cost in the rituximab group, counterbalanced during follow-up by costs related to treatment of patients with persistent disease activity/relapses in the standard corticosteroid (CS) group. Individual costs relating to treatment of adverse events were higher in the standard CS group ((sic)4352) than in the rituximab group ((sic)2468). Overall, mean individual total cost over the 3 years of follow-up was (sic)13 997 in the standard CS arm vs. (sic)14 818 in the rituximab arm, corresponding to a difference of (sic)821 more per patient (+6%). Conclusions First-line treatment of pemphigus with rituximab results in a slightly greater cost compared with a standard CS regimen.