Biosimilars for the management of rheumatoid arthritis: economic considerations

Abstract

Biologic drugs have proved highly effective for the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA). These drugs are often considered cost-effective for well-defined RA patient populations not responding adequately to conventional treatment, but are used first-line relatively rarely, partly due to high costs. Furthermore, not all clinically eligible patients can access biologics even as second-line therapy. Recently, there has been a rise in interest in ‘biosimilar’ drugs that are highly comparable to the ‘reference medicinal product’ (RMP) in terms of efficacy and safety but may generally be lower in price. This review summarizes the cost burden of RA and considers the potential role of biosimilars in reducing drug costs and increasing patient access to biologics.

Keywords:

• biosimilar
• budget savings
• cost–effectiveness
• CT-P13
• pharmacoeconomics
• rheumatoid arthritis

Acknowledgements

Editorial support (writing assistance, assembling tables and figures, collating author comments, grammatical editing and referencing) was provided by Ryan Woodrow (Aspire Scientific Limited, Bollington, UK) and was funded by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea).

Financial & competing interests disclosure

L Gulácsi has been paid as a consultant by Celltrion and received funding and support for research on biosimilars from EGIS Pharma, the distributor of CT-P13 in Hungary. M Péntek, P Baji and V Brodszky have received funding and support for research on biosimilars from EGIS Pharma, the distributor of CT-P13 in Hungary. HU Kim, SY Kim and YY Cho are full-time employees of Celltrion. 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

• Rheumatoid arthritis (RA) is a debilitating disease that leads to increasing levels of disability in working-age patients.

• The economic burden of RA is high and results in huge pressure on healthcare systems, as well as on patients and their families.

• Biologic drugs have revolutionized the treatment of RA and are highly effective. However, because of their complex nature, these drugs are extremely expensive compared with ‘synthetic’ or ‘conventional’ disease-modifying anti-rheumatic drugs (cDMARDs).

• Cost–effectiveness analyses have shown biologics to be cost-effective as second-line therapy in combination with cDMARDs in RA patients who have not adequately responded to cDMARD therapy alone.

• In recent years, interest in so-called ‘biosimilar’ drugs has risen. Biosimilars are highly comparable to ‘reference medicinal product’ (RMP) biologics in terms of their efficacy and safety profiles. A key advantage of biosimilars over RMPs is their lower cost.

• Studies have estimated huge savings to be made through the introduction of biosimilars into the RA setting. Significant savings can be made both from switching patients already on an RMP to biosimilar treatment, as well as from offering biosimilars to biologic therapy-naïve patients.

• Such savings are likely to result in an increase in the number of patients with access to biologic therapy, thereby easing the inequalities that have arisen due to the high cost of RMP biologics. Savings may also be diverted to other aspects of care and thereby ease pressure on healthcare system budgets in general.

Notes