Omalizumab for food allergy: a cost-effectiveness analysis
Published online: June 24, 2024
Families with food allergies and clinicians are optimistic that the approval of omalizumab (OMA) for food allergy will add to the growing landscape of food allergy treatment options. The Omalizumab as Monotherapy and as Adjunct Therapy to Multiallergen OIT in Children and Adults With Food Allergy trial (OUtMATCH) showed that after 16-20 weeks of use, 67% of those randomized to OMA vs 6.7% of those randomized to placebo were able to tolerate either 600 mg (peanut) or 1,000 mg (cashew, egg, milk, wheat, hazelnut) of allergen without moderate or severe symptoms. Making sense of how OMA’s real-world value is challenging, given difficulty in finding a surrogate for effectiveness to identify responders besides food challenge, limited long-term outcomes, and OMA’s high retail price which may limit pharmacoequity.
In a recent issue of The Journal of Allergy and Clinical Immunology: In Practice, Shaker and colleagues present findings of a cost-effectiveness analysis of OMA. The authors evaluated cost-effectiveness of OMA using Markov cohorts of simulated infants (n=40,000) with food allergy over a 15-year time horizon, comparing health-economic outcomes of infants who received OMA with those who did not. The authors took a novel approach of using both individual-level (e.g. change experienced by the food allergic patient) as well as family-level (e.g., change experienced by the entire family) analyses to incorporate broad views of health utility change from a societal perspective, given OMA treatment likely benefits both caregivers and patients in terms of potential reduction in anxiety and improved quality of life.
In the family-level cohort analysis, OMA exceeded usual cost-effectiveness thresholds (willingness-to-pay [WTP] $100,000/Quality-Adjusted Life-Year [QALY]), with an incremental cost-effectiveness ratio (ICER) of $185,183/QALY. When considered in the individual-level analysis, OMA was even less cost-effective ($573,698/QALY). However, while not cost-effective in the base-case, OMA could become cost-effective (WTP, $100,000/QALY) at a cumulative health utility improvement of 26.5% (experienced across the entire family), or at a value-based price of $14,166 (individual-level analysis) to $23,791 (family-level analysis). Of note, universally requiring initial in-office dosing under clinical supervision due to the risk of OMA-associated anaphylaxis (which occurs at a rate of 0.1-0.2%) was not cost-effective (ICER, $260,239/QALY). This study illustrates that OMA’s cost-effectiveness will be limited by how equitably OMA is priced, as well as the importance of considering that health utility change is likely shared across the family and not limited to just one food allergic individual. Health utility in any food allergy therapy, OMA included, has not been directly measured, meaning the only truly adaptable variable is price. This underscores the tenuous pathway which exists for OMA to be cost-effective, and the potential that at the current price, it will only be cost-effective to those with the highest burden of anxiety and poorest quality of life. The challenge also remains to find less invasive measures to determine treatment response in clinical practice than food challenges, which many patients and practices may mutually prefer to avoid. Still, even with this uncertainty, improvements in quality of life among responders may be particularly pronounced for some individuals and their families living with food allergies, helping to prove OMA’s true value in changing these lives for the better.
The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.
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