The Budget Impact of Biosimilar Infliximab (Remsima®) for the Treatment of Autoimmune Diseases in Five European Countries

Abstract

IntroductionInflammatory 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.MethodsA 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.ResultsThe 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.ConclusionThe introduction of Remsima could lead to considerable drug cost-related savings across the six licensed disease areas in the five European countries.FundingMundipharma International Ltd.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-015-0233-1) contains supplementary material, which is available to authorized users.

Evaluation of the cost saving potential of introducing Benepali® and Flixabi® on the European and Italian markets

“…Similar results were achieved by CT-P13 (the first biosimilar to infliximab) in two economic models built by Jha et al [29] and Brodszky et al [30]. The budget impact performed by Jha et al [29], which considered both switch and naïve patients, showed that, during the first year after launch in Germany, UK, Italy, the Netherlands, and Belgium, CT-P13 was associated with a potential savings equal to € 25.789, € 51.578, and € 77.367 in the three discount scenarios considered (10, 20 and 30%, respectively) and for all the indications approved. Furthermore, 1,960, 4,410, 7,561 additional patients could be treated with CT- through investment and collection of realworld evidence that help to increase willingness on clinicians.…”

“…Finally, even when applied to the Spanish setting (assuming a 10% discount of Benepali ® vs. Enbrel), this budget impact model showed that a more rapid uptake of Benepali ® (market share = 20%, 40%, and 60% at year 1, 2, and 3, respectively) resulted in a greater saving (€ 24.5 mln over 3 years) vs. a slower adoption rate (market share = 10%, 20%, and 30% at year 1, 2, and 3, respectively, saving over 3 years: € 12.3 mln) [28]. Similar results were achieved by CT-P13 (the first biosimilar to infliximab) in two economic models built by Jha et al [29] and Brodszky et al [30]. The budget impact performed by Jha et al [29], which considered both switch and naïve patients, showed that, during the first year after launch in Germany, UK, Italy, the Netherlands, and Belgium, CT-P13 was associated with a potential savings equal to € 25.789, € 51.578, and € 77.367 in the three discount scenarios considered (10, 20 and 30%, respectively) and for all the indications approved.…”

Infliximab Biosimilar (Remsima™) in Therapy of Inflammatory Bowel Diseases Patients: Experience from One Tertiary Inflammatory Bowel Diseases Centre

“…This is very important mainly in patients with chronic diseases such as IBD who require long-standing treatment. An economic model for the introduction of biosimilar IFX in 5 West European countries showed potential considerable cost-saving effects already within 1 year of therapy [23] . Similarly, a 3-year budget impact analysis in countries from Central and Eastern Europe reported substantial cost-saving by using biosimilar IFX [24] .…”

Biosimilar infliximab for the management of rheumatoid arthritis in France: what are the expected savings?

“…For example, the study by Brodszky et al showed that the introduction of biosimilar infliximab in six Central and Eastern European countries could lead to substantial cost saving of €15.3 million to €20.8 million over a 3-year period, depending on the scenario envisioned 19. In 2015, Jha et al 20 considered the impact over 1 year of the introduction of biosimilar infliximab in five European countries for the treatment of inflammatory autoimmune diseases (RA, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis and psoriatic arthritis) and showed cumulative cost saving of €77.37 million with a 30% discount. Another study carried out by Kim et al found total 5-year savings of €96 million to €433 million for the management of RA across the UK, Italy, France and Germany 23…”