Cost per Responder Analysis of Certolizumab Pegol vs. Adalimumab in Patients With Moderate to Severe Active Rheumatoid Arthritis and High Rheumatoid Factor Levels: A Payer Perspective From France, Germany, Italy, and United Kingdom
Author(s)
Mohammed Soomro, MPharmS1, Baran Ufuktepe, MD, PhD2, Nicola Tilt, MSc1, Flore Decuypere, MSc-MIM3, Elide Toniolo, MD4, Angela Blake, MSc1, Sandeep Kiri, MSc1, Rémi Marty, PharmD3.
1UCB Pharma, Slough, United Kingdom, 2UCB Pharma, Istanbul, Turkey, 3UCB Pharma, Brussels, Belgium, 4UCB Pharma, Madrid, Spain.
1UCB Pharma, Slough, United Kingdom, 2UCB Pharma, Istanbul, Turkey, 3UCB Pharma, Brussels, Belgium, 4UCB Pharma, Madrid, Spain.
OBJECTIVES: High rheumatoid factor (RF) levels are recognised by EULAR as a poor prognostic marker in rheumatoid arthritis (RA) and are associated with reduced response to Fc-containing monoclonal anti-TNF agents due to Fc-mediated immune activation. Certolizumab pegol (CZP), may offer improved clinical outcomes in this subgroup due to its Fc-free molecular structure. This study assessed the cost per responder (CPR) of CZP versus adalimumab (ADA) in patients with moderate to severe RA and high RF (>200 IU/mL) from the healthcare payer perspectives of France, Germany, Italy, and the UK.
METHODS: A 104-week (Wk) CPR model was developed using data from EXXELERATE, a phase IV, head-to-head trial comparing CZP+methotrexate (MTX) to ADA+MTX. Response was defined as achieving low disease activity (LDA) measured by DAS28-CRP ≤2.7 at Wk104. CPR was calculated as total drug acquisition cost over 104 weeks divided by the corresponding response rate. Treatment regimens followed the approved product labels: CZP 400mg at Wk 0, 2, and 4, then 200mg every 2 weeks; ADA 40mg every other week. Country-level average biosimilar list price data were used to estimate ADA costs.
RESULTS: In patients with high RF levels, LDA response rates at Wk104 were 42.5% for CZP and 25.5% for ADA. The CPR (CZP vs ADA) by country was: France, €35,242 vs €38,190; Germany, €49,278 vs €75,996; Italy, €67,275 vs €78,537; UK, €56,567 vs €79,521. On average across the four countries, CPR was €52,090 for CZP and €68,061 for ADA.
CONCLUSIONS: In patients with moderate to severe RA and high RF levels, CZP at list price demonstrated a lower CPR than ADA biosimilar list price in all four countries at Wk104, with the greatest cost advantage seen in Germany and the UK. However, results should be interpreted with caution, as real-world procurement costs may affect comparative CPR.
METHODS: A 104-week (Wk) CPR model was developed using data from EXXELERATE, a phase IV, head-to-head trial comparing CZP+methotrexate (MTX) to ADA+MTX. Response was defined as achieving low disease activity (LDA) measured by DAS28-CRP ≤2.7 at Wk104. CPR was calculated as total drug acquisition cost over 104 weeks divided by the corresponding response rate. Treatment regimens followed the approved product labels: CZP 400mg at Wk 0, 2, and 4, then 200mg every 2 weeks; ADA 40mg every other week. Country-level average biosimilar list price data were used to estimate ADA costs.
RESULTS: In patients with high RF levels, LDA response rates at Wk104 were 42.5% for CZP and 25.5% for ADA. The CPR (CZP vs ADA) by country was: France, €35,242 vs €38,190; Germany, €49,278 vs €75,996; Italy, €67,275 vs €78,537; UK, €56,567 vs €79,521. On average across the four countries, CPR was €52,090 for CZP and €68,061 for ADA.
CONCLUSIONS: In patients with moderate to severe RA and high RF levels, CZP at list price demonstrated a lower CPR than ADA biosimilar list price in all four countries at Wk104, with the greatest cost advantage seen in Germany and the UK. However, results should be interpreted with caution, as real-world procurement costs may affect comparative CPR.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE184
Topic
Economic Evaluation
Topic Subcategory
Budget Impact Analysis, Cost/Cost of Illness/Resource Use Studies
Disease
Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)