OBJECTIVES: In February 2017, the European Medicines Agency has recommended granting marketing authorization to biosimilar rituximab (CT-P10) in all indications of the reference product including diffuse large B-cell (DLBCL) and follicular lymphoma (FL). This study aims to assess the budget impact of the introduction of CT-P10 into the treatment of DLBCL and FL in the 28 EU member states.

METHODS: A third party payer’s perspective budget impact analysis was performed to evaluate the one-year cost outcomes under two scenarios with and without the availability of CT-P10. Market uptake of CT-P10 was assumed to be 30%. Based on expert opinion, it was assumed that when CT-P10 is entering the market it will be at 50-70% of the official list price of originator rituximab in each country. The initial number of patients treated with rituximab was estimated from IMS sales data on total annual consumption of originator rituximab in 2016. Sensitivity analysis was undertaken to test the robustness of model assumptions.

RESULTS: The one-year budget impact of adopting CT-P10 is estimated to be €39.02 million in the 28 EU member states. Countries responsible for the majority of the cost savings are Germany (€8.91 million), Italy (€6.90 million), France (€5.28 million), Spain (€3.28 million) and the UK (€2.94 million). If the cost savings were used to treat additional patients with CT-P10, a total of 2,263 patients could be treated annually throughout Europe. The potential cost savings are in a direct correlation with the price and market uptake of CT-P10. Applying discount of 40% and 50% in drug prices, cost savings are projected to €52.02 and €65.03 million, from which further 3,520 and 3,771 patients could be treated with CT-P10, respectively.

CONCLUSIONS: Biosimilar rituximab has the potential to improve the affordability of DLBCL and FL treatments and easing the burden of healthcare costs in Europe.