TY - JOUR
T1 - Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma
AU - Porsbjerg, Celeste M.
AU - Menzies-Gow, Andrew
AU - Tran, Trung N
AU - Murray, Ruth B
AU - Unni, Bindhu
AU - Ang, Shi Ling Audrey
AU - Alacqua, Marianna
AU - Al-Ahmad, Mona
AU - Al-Lehebi, Riyad
AU - Altraja, Alan
AU - Belevskiy, Andrey S.
AU - Björnsdóttir, Unnur S.
AU - Bourdin, Arnaud
AU - Busby, John
AU - Walter Canonica, G
AU - Christoff, George
AU - Cosio, Borja G.
AU - Costello, Richard W
AU - FitzGerald, J. Mark
AU - Fonseca, João A.
AU - Hansen, Susanne
AU - Heaney, Liam G
AU - Heffler, Enrico
AU - Hew, Mark
AU - Iwanaga, Takashi
AU - Jackson, David J
AU - Kocks, Janwillem W H
AU - Kallieri, Maria
AU - Bruce Ko, Hsin-Kuo
AU - Siyue, Mariko Koh
AU - Larenas-Linnemann, Désirée
AU - Lehtimäki, Lauri A.
AU - Loukides, Stelios
AU - Lugogo, Njira
AU - Maspero, Jorge F
AU - Papaioannou, Andriana I.
AU - Perez de Llano, Luis
AU - Márcio Pitrez , Paulo
AU - Popov, Todor A
AU - Rasmussen, Linda M.
AU - Rhee, Chin Kook
AU - Sadatsafavi, Mohsen
AU - Schmidt, Johannes
AU - Siddiqui, Salman
AU - Taillé, Camille
AU - Taube, Christian
AU - Torres-Duque, Carlos A.
AU - Ulrik, Charlotte
AU - Upham, John W
AU - Eileen, Wang
AU - Wechsler, Michael E
AU - Bulathsinhala, Lakmini
AU - Carter, Victoria
AU - Chaudhry, Isha
AU - Eleangovan, Nevaashni
AU - Hosseini, Naeimeh
AU - Rowlands, Mari-Anne
AU - Price, David
AU - van Boven, Job FM
N1 - Funding: This research study was funded and delivered by the Observational & Pragmatic Research Institute Pte Ltd (OPRI). The International Severe Asthma Registry is co-funded by Optimum Patient Care Global Limited and AstraZeneca.
PY - 2022/1/3
Y1 - 2022/1/3
N2 - 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 prescriptioncriteria 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.
AB - 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 prescriptioncriteria 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.
KW - severe asthma
KW - Biologics access
KW - Biologic eligibility
U2 - https://doi.org/10.1016/j.jaip.2021.12.027
DO - https://doi.org/10.1016/j.jaip.2021.12.027
M3 - Article
JO - The Journal of Allergy and Clinical Immunology: In Practice
JF - The Journal of Allergy and Clinical Immunology: In Practice
SN - 2213-2198
ER -