Abstract
BACKGROUND: Regulatory bodies have approved five biologics for severe asthma. However, regional differences in accessibility may limit the global potential for personalized medicine.
OBJECTIVE: To compare global differences in ease-of-access to biologics.
METHODS: In April 2021, national prescription criteria for omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab were reviewed by severe asthma experts collaborating in the International Severe Asthma Registry. Outcomes (per country, per biologic) were (1) country-specific prescription
criteria and (2) development of the Biologic ACcessibility Score (BACS). The BACS composite score incorporates 10 prescription criteria, each with a maximum score of 10 points. Referenced to European Medicines Agency (EMA) marketing authorization specifications, a higher score reflects easier access.
RESULTS: Biologic prescription criteria differed substantially across 28 countries from 5 continents. Blood eosinophil count thresholds (usually ≥300 cells/μL) and exacerbations were key requirements for anti-IgE/anti–IL-5/5R prescription in around 80% of the licensed countries. Most countries (40% for dupilumab to 54% for mepolizumab) require ≥2 moderate/severe exacerbations, while numbers ranged between none to four. Between 0% (for reslizumab) and 21% (for omalizumab) of countries also required long-term oral corticosteroid use. The BACS highlighted marked between-country differences in ease-of access. For omalizumab, mepolizumab, benralizumab, and dupilumab, only two, one, four and seven countries respectively scored equal or higher than the EMA reference BACS. For reslizumab, all countries scored lower.
CONCLUSIONS: Although some differences in country-specific biologic prescription criteria and ease338 of-access were expected, the substantial differences found in the current study present a challenge to the implementation of precision medicine across the world.
OBJECTIVE: To compare global differences in ease-of-access to biologics.
METHODS: In April 2021, national prescription criteria for omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab were reviewed by severe asthma experts collaborating in the International Severe Asthma Registry. Outcomes (per country, per biologic) were (1) country-specific prescription
criteria and (2) development of the Biologic ACcessibility Score (BACS). The BACS composite score incorporates 10 prescription criteria, each with a maximum score of 10 points. Referenced to European Medicines Agency (EMA) marketing authorization specifications, a higher score reflects easier access.
RESULTS: Biologic prescription criteria differed substantially across 28 countries from 5 continents. Blood eosinophil count thresholds (usually ≥300 cells/μL) and exacerbations were key requirements for anti-IgE/anti–IL-5/5R prescription in around 80% of the licensed countries. Most countries (40% for dupilumab to 54% for mepolizumab) require ≥2 moderate/severe exacerbations, while numbers ranged between none to four. Between 0% (for reslizumab) and 21% (for omalizumab) of countries also required long-term oral corticosteroid use. The BACS highlighted marked between-country differences in ease-of access. For omalizumab, mepolizumab, benralizumab, and dupilumab, only two, one, four and seven countries respectively scored equal or higher than the EMA reference BACS. For reslizumab, all countries scored lower.
CONCLUSIONS: Although some differences in country-specific biologic prescription criteria and ease338 of-access were expected, the substantial differences found in the current study present a challenge to the implementation of precision medicine across the world.
| Original language | English |
|---|---|
| Journal | The Journal of Allergy and Clinical Immunology: In Practice |
| Publication status | Accepted/In press - 7 Dec 2021 |
Keywords
- severe asthma
- Biologics access
- Biologic eligibility