Ethical Approach to Prescribing Biologic Inhalers in Pediatric Asthma
It is inappropriate to prescribe an expensive biologic medication without clear medical need, and the provider must disclose their previous involvement with the drug regardless of whether direct financial compensation was received. 1
Clinical Necessity Must Drive the Decision
The fundamental ethical principle is that clinical necessity, not cost alone, determines the appropriateness of biologic therapy 1. However, this does not mean cost is irrelevant—prescribing expensive biologics without medical justification violates evidence-based practice and ethical standards 1.
Biologics Require Documented Treatment Failure
Before any biologic can be ethically prescribed, the following must be verified 1:
- High-dose inhaled corticosteroids (ICS) with proper technique confirmed have failed to control asthma 1
- Additional controllers have been tried, including leukotriene receptor antagonists 1
- Environmental triggers have been addressed, particularly maternal smoking 1
- Adherence has been verified—many children fail treatment due to poor technique or non-compliance, not medication inadequacy 1
Biologics should only be considered for severe asthma refractory to optimized standard therapy, with evidence showing 40-70% reduction in severe exacerbations in appropriately selected patients 1. The European Respiratory Society is explicit that biologics like omalizumab, mepolizumab, dupilumab, and tezepelumab should only be considered when asthma remains uncontrolled despite adherence to high-dose ICS 1.
The Transparency Imperative
The provider must disclose any financial relationships with the manufacturer, as recommended by the World Health Organization 1. This includes:
- Speaking at conferences about the drug (as in this scenario)
- Consulting arrangements
- Research funding
- Any other professional relationship
The American Medical Association states that while cost alone does not determine appropriateness, generic ICS formulations are the appropriate initial treatment and must be tried before considering biologics 1. The fact that the provider has given a conference about this specific drug creates a potential conflict of interest that must be disclosed during informed consent 1.
Critical Pitfalls to Avoid
The American Academy of Pediatrics identifies three cardinal violations 1:
- Never prescribe biologics as first-line therapy—ICS are the preferred first-line controller for all children with persistent asthma 1
- Never skip the ICS trial—inhaled corticosteroids demonstrate superior efficacy in improving lung function, reducing exacerbations, and decreasing hospitalizations compared to all other long-term controller options 1
- Never fail to disclose financial relationships—this violates both evidence-based guidelines and ethical principles 1
Informed Consent Requirements
The National Institute for Health and Care Excellence recommends discussing 1:
- Realistic expectations of biologic therapy
- Alternative options that remain untried (different ICS doses, additional controllers, environmental modifications)
- The provider's relationship with the manufacturer, including conference presentations
Why This Matters for Patient Outcomes
The British Thoracic Society guidelines emphasize that many expensive treatments are prescribed prematurely when simpler interventions would suffice 2. For example, nebulizers are noted as "overused both in hospital and in the community. They are expensive, time consuming, and inefficient. They may often be replaced by large volume spacer devices" 2. This same principle applies to biologics—expensive does not mean better when standard therapy has not been optimized.
The most recent evidence confirms that omalizumab has the most robust long-term safety data in children, as several biologics have been available for a relatively short time 3. This underscores the importance of not rushing to newer, potentially less-studied options without clear medical justification.