Budget Impact Analysis of Switching to Rituximab's Biosimilar in Rheumatology and Cancer in 13 Countries Within the Middle East and North Africa.

Introduction: Biosimilars of monoclonal antibodies are being rapidly developed and approved by public health regulatory authorities worldwide. These biosimilars are expected to bring significant budgetary savings to national governments and consequently increase patients' accessibility to biological therapy. Rituximab has been used extensively for the treatment of cancer and rheumatoid disorders over the past two decades. New biosimilars of Rituximab have been developed and introduced into clinical practice. We have analyzed the budgetary impact and savings outcome of introducing Rituximab's biosimilar into 13 countries within the Middle East and North Africa through the implementation of a budget impact analysis model.

Methods: Our model was based on a 1-year full uptake and switch scenario of the Rituximab's biosimilar CT-P10. The model calculated the total number of patients based on the total national consumption of Rituximab per country. Accordingly, the model produced savings per each indication which were translated into the additional number of patients that would be permitted access to Rituximab's therapy as a result of these savings.

Results: In our modeling scenario, the total projected savings that will result from the uptake of Rituximab's biosimilar within the MENA region were estimated to be 46.59 million dollars. The cumulative savings in all 13 countries would allow access of Rituximab's therapy for a total of 6589 patients which is equivalent to a 14% increase in the number of patients benefiting from Rituximab's therapy.

Conclusion: The introduction of Rituximab's biosimilar within the Middle East and North Africa region is associated with significant budgetary savings that will allow public national health authorities to reinvest such economic gains either in expanding access to Rituximab therapy or other costly lifesaving biologicals.