Background Tocilizumab (TCZ) is an interleukin-6 receptor inhibitor for treatment of patients (pts) with moderate to severe rheumatoid arthritis (RA) and inadequate response to disease modifying anti-rheumatic drugs (DMARDS) or anti-Tumor Necrosis Factor agents. In SUMMACTA, a randomized study of the safety and efficacy of subcutaneous (SC) TCZ vs intra-venous (IV) TCZ in combination with traditional DMARDS, TCZ-SC demonstrated comparable efficacy to TCZ-IV. The safety profile of TCZ-SC was consistent with the known and well established one of TCZ-IV. In December 2013 TCZ-SC obtained a positive CHMP opinion
Objectives In light of future arrival of TCZ-SC in the Italian market, a multidimensional analysis has been performed in order to evaluate potential impact of introducing SC formulation vs IV one from the perspective of both patients and hospitals in Italy.
Methods The analysis was conducted in 3 Italian Rheumatology Centers (6 pts observed per Centre) through a questionnaire administered to clinicians and nurses. A 60 minutes day-hospital administration for IV and 20 seconds-1 minute administration for SC selfinjector or pre-filled syringe administered at home (excluding the first administration) were assumed. Monitoring visits were considered as 1 per month for IV and 1 every 3 months for SC. Evaluated impact areas were: pts time and costs, hospital-personnel time and pts risk profile as Risk Priority Number (RPN). Pts time considered transportation to the hospital and drug administration. Pts costs considered transportation and loss of productivity due to drug administration time monetized using national mean gross annual salary. Hospital-personnel time was measured as Full Time Equivalent (FTE) Pts risk was evaluated through Failure Models and Effect Analysis. 1 year time horizon was considered.
Results The analysis showed that SC formulation vs IV could have a significant impact in terms of: pts time saving (- 91%), pts costs (-86%), clinician and nurse time saving (-59% and -94% respectively) and pts risk profile (-90%). Following table shows the main impact areas analyzed and the difference between TCZ-SC and IV.
Conclusions The SC formulation of TCZ could have several organizational and management impacts. From the hospital perspective it could lead to reduction of medical resources consumption with the possibility to reallocate them in other medical activities. From the patient perspective the new SC formulation could lead to time savings and costs reduction with a potential improvement of patient quality of life.
Burmester GR, Rubbert-Roth A, et al. A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTAstudy). Ann Rheum Dis. 2013 Sep 12. doi:10.1136/annrheumdis-2013-203523
Acknowledgements This study was supported by Roche S.p.A. Italy.
Disclosure of Interest R. Tomic Employee of: Roche S.p.A., S. Adami: None declared, O. Viapiana: None declared, L. Bianchino Employee of: Roche S.p.A., M. Canciani Consultant for: Roche S.p.A., M. Farina Consultant for: Roche S.p.A., G. Ciancio: None declared, S. Ravera Employee of: Roche S.p.A., M. Govoni: None declared