OBJECTIVES: This study explores the role of reimbursement guidelines in access to omalizumab, an anti-IgE antibody used to treat allergic asthma (AA), chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP). The high cost and stringent eligibility criteria of omalizumab create significant barriers to treatment. This research investigates the perspectives of healthcare professionals (HCPs) and stakeholders on these challenges and assesses the potential impact of the biosimilar omalizumab biosimilar in mitigating these issues, including shortage and potential off-label uses.

METHODS: A review of reimbursement guidelines for omalizumab was conducted across European countries, focusing on national health insurance policies. In-depth qualitative interviews were carried out with HCPs to gain insights into practical challenges in prescribing omalizumab and expectations from the introduction of omalizumab biosimilar.

RESULTS: The findings reveal disparities in the access to omalizumab. HCPs from 18 out of 25 countries addressed the need for improvement in accessibility. For instance, Norway and Portugal do not include omalizumab in their national insurance coverage for AA. Patients with CRSwNP in countries like France, the UK, and Spain also face barriers due to lack of reimbursement. Criteria for treatment initiation are stringent, with some countries requiring evidence of multiple severe asthma exacerbations or high urticaria activity scores for eligibility. The average price reduction of omalizumab biosimilar compared to the originator is on average 34%. When compared with dupilumab, mepolizumab, and tezepelumab, the expected annual savings would average 43%, with a maximum of 75%.

CONCLUSIONS: The disparities highlighted in this study underscore the need for improvement in access to omalizumab across Europe. This study highlights the need for comprehensive policy reforms and the introduction of omalizumab biosimilar to ensure equitable access to omalizumab across Europe, enhancing patient care and potentially solving shortage issues and expanding treatment options for off-label indications such as urticarial vasculitis and food allergy.