A budget impact model for biosimilar infliximab in Crohn’s disease in Bulgaria, the Czech Republic, Hungary, Poland, Romania, and Slovakia

Abstract

Objectives: To estimate the budget impact of the introduction of biosimilar infliximab for the treatment of Crohn’s disease (CD) in Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia. Methods: A 3-year, prevalence-based budget impact analysis for biosimilar infliximab to treat CD was developed from third-party payers’ perspective. The model included various scenarios depending on whether interchanging originator infliximab with biosimilar infliximab was allowed or not. Results: Total cost savings achieved in biosimilar scenario 1 (interchanging not allowed) and BSc2 (interchanging allowed in 80% of the patients) were estimated to €8.0 million and €16.9 million in the six countries. Budget savings may cover the biosimilar infliximab therapy for 722–1530 additional CD patients. Conclusions: Introduction of biosimilar infliximab to treat CD may offset the inequity in access to biological therapy for CD between Central and Eastern European countries.

Keywords:

• biosimilar drugs
• budget impact analysis
• Central and Eastern Europe
• Crohn’s disease
• inflammatory bowel diseases
• infliximab

Financial & competing interests disclosure

The development of the model was supported by an unrestricted grant from Centre for Public Affairs Studies Foundation and EGIS Pharmaceuticals. V Brodszky, M Péntek, P Baji, L Gulácsi were paid for consultancy activities to prepare health technology assessment reports and were invited as speakers at various conferences by Egis Pharmaceuticals. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues

• Access to biologics in Crohn’s disease (CD) is fairly low in many Central and Eastern European (CEE) countries. High budget impact of biologics might be a reason for the low use of biologics in this region.

• From 2014, biosimilar infliximab has begun to be marketed first in CEE with a price reduction of approximately 20–25%.

• This study estimates the cost savings that can be generated over a 3-year time frame by the use of biosimilar infliximab for the treatment of CD in six CEE countries, namely Bulgaria, the Czech Republic, Hungary, Poland, Romania, and Slovakia.

• The model included three scenarios including a reference scenario, where biosimilars were not available, and two alternative biosimilar scenarios. In biosimilar scenario 1 (BSc1), interchanging between originator infliximab and biosimilar infliximab was not allowed; whereas in BSc2, we assumed that interchanging between originator infliximab and biosimilar infliximab was allowed from 6 months after the initiation of the treatment in 80% of the patients.

• Total cost savings achieved in BSc1 and BSc2 over the 3 years were estimated to €8.0 and 16.9 million, respectively, in the six countries.

• Sensitivity analysis revealed that drug acquisition costs and size of initial patient population were the most important predictors of costs.

• If cost savings were reinvested in further treatments with biosimilar infliximab, overall 722 and 1530 additional CD patients could receive reimbursed therapy. Thereby, reimbursement of biosimilar infliximab for CD would greatly promote better access to biological therapy for CD patients in CEE.