Rituximab Biosimilar Estimated to Save €90 Million Annually in the EU

After being recently approved in Europe, a biosimilar for the drug rituximab (MabThera in Europe) could result in considerable savings over the reference drug for the 28 European Union countries, according to a study in Advances in Therapy.

The analysis discusses how using the biosimilar CT-P10 in place of rituximab, could impact both budgets and patients’ ability to access the medicine. CT-P10, sold as Truxima, was approved this February for all indications of the reference drug, which include cancers like non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL), in addition to autoimmune disorders, such as rheumatoid arthritis (RA). These 3 conditions, which account for 90% of all rituximab consumed in the study setting, were the primary focus of the new budget analysis.

Researchers estimated the proportion of patients with all diagnoses who will receive CT-P10 instead of the branded drug over a 1-year period at 30%. They also calculated the costs for both the biosimilar and the reference based on the list price and annual dose in milligrams of drug required for each diagnosis. Assuming the CT-P10 would cost 70% of what the branded drug does, the projected budget savings in Europe totaled just over €90 million in 1 year. The researchers also projected that these savings would allow 7531 additional patients to access rituximab therapy that year, or a 6.4% increase in patients taking rituximab.

Specifically, 43.3% of the savings would come from the treatment of NHL, while approximately 26.9% and 19.8% would come from treating RA and CLL, respectively. The bulk of the savings (70%) would occur in 5 European countries: Germany (22.8%), Italy (17.7%), France (13.5%), Spain (8.4%), and the United Kingdom (7.5%). Of the 7531 additional patients projected to gain access to rituximab treatment, 2857 would use it to treat RA, 2263 would use it for NHL, and 1624 would take it for CLL, while 787 would use it for a less common diagnosis or an off-label use.

The researchers then modeled potential budget savings and expanded patient access in a 3-year scenario where CT-P10’s market share would be 30% in the first year, 40% in the second, and 50% in the third. They estimated that Europe would save about €570 million in this scenario, which would allow 47,695 more patients to access treatment.

“These data clearly represent a substantial societal health gain and it can be concluded from our findings that, with some assumptions as defined in the model, use of CT-P10 will present significant savings for healthcare systems, in accordance with our stated hypothesis,” the study authors wrote.

They noted that their estimates could be on the conservative side if the price of CT-P10 is substantially lower than expected; their models assumed the biosimilar price would be 30% less costly than branded rituximab, but industry experts have said the actual difference could be twice as great.

However, the study authors acknowledged that the cost savings represent just one of the many factors that influence the uptake of biosimilars, including perceptions of the new drugs among patients, payers, and prescribers. For instance, clinicians must feel confident that CT-P10 is just as safe and effective as the branded drug for both, treatment-naïve patients and those switching from the branded drug to the biosimilar.