Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma

Celeste M Porsbjerg, Andrew N Menzies-Gow, Trung N Tran, Ruth B Murray, Bindhu Unni, Shi Ling Audrey Ang, Marianna Alacqua, Mona Al-Ahmad, Riyad Al-Lehebi, Alan Altraja, Andrey S Belevskiy, Unnur S Björnsdóttir, Arnaud Bourdin, John Busby, G Walter Canonica, George C Christoff, Borja G Cosio, Richard W Costello, J Mark FitzGerald, João A FonsecaSusanne Hansen, Liam G Heaney, Enrico Heffler, Mark Hew, Takashi Iwanaga, David J Jackson, Janwillem W H Kocks, Maria Kallieri, Hsin-Kuo Bruce Ko, Mariko Siyue Koh, Désirée Larenas-Linnemann, Lauri A Lehtimäki, Stelios Loukides, Njira Lugogo, Jorge Maspero, Andriana I Papaioannou, Luis Perez-de-Llano, Paulo Márcio Pitrez, Todor A Popov, Linda M Rasmussen, Chin Kook Rhee, Mohsen Sadatsafavi, Johannes Schmid, Salman Siddiqui, Camille Taillé, Christian Taube, Carlos A Torres-Duque, Charlotte Ulrik, John W Upham, Eileen Wang, Michael E Wechsler, Lakmini Bulathsinhala, Victoria Carter, Isha Chaudhry, Neva Eleangovan, Naeimeh Hosseini, Mari-Anne Rowlands, David Price, Job Fm van Boven

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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 ease-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 languageEnglish
Pages (from-to)1202-1216.e23
JournalThe Journal of Allergy and Clinical Immunology: In Practice
Issue number5
Publication statusPublished - 05 May 2022

Bibliographical note

Copyright © 2021. Published by Elsevier Inc.


  • Biologics access
  • Biologics eligibility
  • Severe asthma


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