Mapping food allergy care with omalizumab and real-world data

IgE-mediated food allergies (FAs) pose a significant health risk due to their potential to cause life-threatening reactions, such as anaphylaxis. These conditions represent a critical area of public health surveillance, impacting millions of patients and placing considerable strain on healthcare systems. On February 16, 2024, the FDA approved a biologic therapy, omalizumab (brand name Xolair), for IgE-mediated food allergies, marking an important milestone in allergy treatment, but the data shows an interesting trend.¹ 

Utilizing the nation's largest healthcare and consumer data ecosystem, HealthVerity Marketplace enabled researchers to examine national healthcare medical claims and pharmacy claims data, providing unmatched coverage and source-stability to analyze treatment patterns.¹

Precision in allergy treatment: understanding IgE mechanisms and omalizumab

IgE-mediated food allergies occur when the immune system mistakenly identifies specific food proteins as harmful, triggering IgE antibodies that activate mast cells and basophils. This activation releases histamine and other mediators, causing allergic reactions ranging from mild to severe.²
The newly approved biologic, omalizumab, is a monoclonal antibody that selectively binds free IgE, reducing allergic sensitivity and the likelihood of severe reactions. Its approval signifies an essential therapeutic advancement, offering precision treatment to affected patients.²

Transparency and rigor in methodology: claims-based analysis

This retrospective claims-based analysis used healthcare and pharmacy claims data from the HealthVerity Marketplace.¹ Researchers identified medical claims for food allergy diagnoses (ICD-10 code Z91.01) and pharmacy claims for the biologic treatment omalizumab between January 1, 2012, and August 15, 2024. Transparency in data sourcing and explicit governance standards ensured clear, verifiable results.

Figure 1 shows the overlap between patients diagnosed with food allergies and those who received omalizumab therapy, providing detailed demographic insights.

Demographic insights and utilization trends of omalizumab

The analysis identified a total of 18.9 million healthcare claims for food allergies and 67,000 pharmacy claims for omalizumab. However, only 14,000 of these claims overlapped, representing just 0.07% of food allergy claims.

Figure 1: The overlap between patients diagnosed with food allergies and those who received omalizumab therapy. Only 14,000 patients diagnosed with food allergies received omalizumab as a therapy (pink overlap). Data from Wan et al., 2025 

Among those patients approved for omalizumab treatment, demographic patterns emerged (Figure 2):

• 81.6% female, 18.4% male
• Age distribution:
  • 0-17 years: 16.0%
  • 18-44 years: 35.8%
  • 45-64 years: 44.9%
  • 65 and older: 3.3%

Figure 2: Gender and age demographic patterns for patients approved for omalizumab treatment from Wan et al., 2025 

Stability of market access and strategic insights

The study's findings underscore the relatively low early adoption of omalizumab, highlighting stability concerns around market penetration and insurance approval processes. Pharmaceutical companies can use these insights to develop targeted strategies, improving market access, provider education, and patient advocacy.

For government and public health authorities, this analysis using HealthVerity Marketplace provides a stable foundation for ongoing surveillance and identification of access disparities, guiding policy development and resource allocation to enhance patient outcomes.

Using HealthVerity Marketplace for actionable insights

HealthVerity Marketplace provides Verified access to:

• Precise demographic insights through linked, privacy-compliant claims data
  
  
• Transparent treatment adoption patterns across diverse populations
  
  
• Stable data sources that support reliable longitudinal analyses
  
  

We cover more use-cases and explore how HealthVerity Marketplace works in our webinar, watch a replay or read more here.

References

1. Wan L, Lee-wong M, Promisloff R, et al. National demographic trends and approval rates for omalizumab use to treat food allergy: a retrospective claims-based analysis since fda approval. Journal of Allergy and Clinical Immunology. 2025;155(2):AB139.
2. Bégin, P., Waserman, S., Protudjer, J.L.P. et al. Immunoglobulin E (IgE)-mediated food allergy. Allergy Asthma Clin Immunol 20 (Suppl 3), 75 (2024).