The Budget Impact of Biosimilar Infliximab (Remsima®) for the Treatment of Autoimmune Diseases in Five European Countries.
BACKGROUND
Inflammatory autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis) have a considerable impact on patients' quality of life and healthcare budgets. Biosimilar infliximab (Remsima(®)) has been authorized by the European Medicines Agency for the management of inflammatory autoimmune diseases based on a data package demonstrating efficacy, safety, and quality comparable to the reference infliximab product (Remicade(®)). This analysis aims to estimate the 1-year budget impact of the introduction of Remsima in five European countries.


METHODS
A budget impact model for the introduction of Remsima in Germany, the UK, Italy, the Netherlands, and Belgium was developed over a 1-year time horizon. Infliximab-naïve and switch patient groups were considered. Only direct drug costs were included. The model used the drug-acquisition cost of Remicade. The list price of Remsima was not known at the time of the analysis, and was assumed to be 10-30% less than that of Remicade. Key variables were tested in the sensitivity analysis.


RESULTS
The annual cost savings resulting from the introduction of Remsima were projected to range from €2.89 million (Belgium, 10% discount) to €33.80 million (Germany, 30% discount). If any such savings made were used to treat additional patients with Remsima, 250 (Belgium, 10% discount) to 2602 (Germany, 30% discount) additional patients could be treated. The cumulative cost savings across the five included countries and the six licensed disease areas were projected to range from €25.79 million (10% discount) to €77.37 million (30% discount). Sensitivity analyses showed the number of patients treated with infliximab to be directly correlated with projected cost savings, with disease prevalence and patient weight having a smaller impact, and incidence the least impact.


CONCLUSIONS
The introduction of Remsima could lead to considerable drug cost-related savings across the six licensed disease areas in the five European countries.


BACKGROUND
Mundipharma International Ltd.
Mundipharma International Ltd., Cambridge, UK.
Ashok
A
Jha
Abacus International, Bicester, UK.
Alex
A
Upton
Mundipharma International Ltd., Cambridge, UK. will.dunlop@mundipharma.co.uk.
William C N
WC
Dunlop
School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.|BresMed Health Solutions Limited, Northchurch Business Centre, Sheffield, UK.
Ron
R
Akehurst
D000368:Aged; D000911:Antibodies, Monoclonal / Q000191:economics / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000191:economics / Q000627:therapeutic use; D015535:Arthritis, Psoriatic / Q000188:drug therapy / Q000191:economics; D001172:Arthritis, Rheumatoid / Q000188:drug therapy / Q000191:economics; D059451:Biosimilar Pharmaceuticals / Q000191:economics / Q000627:therapeutic use; D017046:Cost Savings / Q000379:methods / Q000706:statistics & numerical data; D016527:Drug Costs / Q000706:statistics & numerical data*; D005060:Europe; D005260:Female; D006801:Humans; D000069285:Infliximab / Q000191:economics / Q000627:therapeutic use; D008297:Male; D017059:Models, Econometric; D011306:Prescription Fees / Q000706:statistics & numerical data*; D013167:Spondylitis, Ankylosing / Q000188:drug therapy / Q000191:economics
D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D000069285:Infliximab
Ankylosing spondylitis; Biosimilar; Crohn’s disease; Infliximab; Psoriasis; Psoriatic arthritis; Remicade®; Remsima®; Rheumatoid arthritis; Ulcerative colitis