Journal of medical economics · 2025
Budget impact of introducing an omalizumab biosimilar in 23 European countries.
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Jang Minyoung, Lee Jooyeop, Yi Seungjae, Kwon Taek Sang
Аннотация
BACKGROUND: Omalizumab, a monoclonal antibody indicated for severe persistent allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP), imposes a financial burden on European healthcare systems due to its high cost, with expenditures exceeding €787 million across 23 countries in 2024. Introducing an omalizumab biosimilar offers a promising avenue to reduce expenditure while maintaining clinical outcomes.
OBJECTIVE: To evaluate the budgetary impact of introducing an omalizumab biosimilar for severe persistent allergic asthma, CSU, and CRSwNP across 23 European countries from a payer's perspective.
METHODS: A biosimilar market share uptake-based budget impact model (BIM) was developed in Microsoft Excel to compare two scenarios over 5 years: one without biosimilar introduction and one with gradual adoption. Market share evolution was modeled using country-specific biosimilar uptake as a proxy, while omalizumab usage growth was estimated from historical compound annual growth rates. Drug acquisition costs came from national price databases, assuming a 30% discount for the biosimilar. Sensitivity analysis applying 50% and 70% discount rates was conducted to reflect reimbursed cost from the payer's perspective.
RESULTS: Introducing an omalizumab biosimilar is projected to save €40 million in the first year at a 30% discounted price compared with using only the originator across 23 countries. Over 5 years, cumulative savings could reach €640 million, potentially enabling treatment for ∼96,000 additional patients per year from the derived budget savings. These estimates are a conservative baseline because the model does not incorporate competitive price erosion of the originator following biosimilar entry; in real-world settings, savings are typically higher when originator prices decline in response to competition.
CONCLUSION: Adopting an omalizumab biosimilar in European healthcare systems could yield substantial cost savings, enhance patient access, and reduce fiscal pressure. This analysis supports biosimilars as a strategic tool for sustainable biologic therapy access in Europe.
OBJECTIVE: To evaluate the budgetary impact of introducing an omalizumab biosimilar for severe persistent allergic asthma, CSU, and CRSwNP across 23 European countries from a payer's perspective.
METHODS: A biosimilar market share uptake-based budget impact model (BIM) was developed in Microsoft Excel to compare two scenarios over 5 years: one without biosimilar introduction and one with gradual adoption. Market share evolution was modeled using country-specific biosimilar uptake as a proxy, while omalizumab usage growth was estimated from historical compound annual growth rates. Drug acquisition costs came from national price databases, assuming a 30% discount for the biosimilar. Sensitivity analysis applying 50% and 70% discount rates was conducted to reflect reimbursed cost from the payer's perspective.
RESULTS: Introducing an omalizumab biosimilar is projected to save €40 million in the first year at a 30% discounted price compared with using only the originator across 23 countries. Over 5 years, cumulative savings could reach €640 million, potentially enabling treatment for ∼96,000 additional patients per year from the derived budget savings. These estimates are a conservative baseline because the model does not incorporate competitive price erosion of the originator following biosimilar entry; in real-world settings, savings are typically higher when originator prices decline in response to competition.
CONCLUSION: Adopting an omalizumab biosimilar in European healthcare systems could yield substantial cost savings, enhance patient access, and reduce fiscal pressure. This analysis supports biosimilars as a strategic tool for sustainable biologic therapy access in Europe.