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

Celeste M Porsbjerg¹, Andrew N Menzies-Gow², Trung N Tran³, Ruth B Murray⁴, Bindhu Unni⁴, Shi Ling Audrey Ang⁴, Marianna Alacqua⁵, Mona Al-Ahmad⁶, Riyad Al-Lehebi⁷, Alan Altraja⁸, Andrey S Belevskiy⁹, Unnur S Björnsdóttir¹⁰, Arnaud Bourdin¹¹, John Busby¹², G Walter Canonica¹³, George C Christoff¹⁴, Borja G Cosio¹⁵, Richard W Costello¹⁶, J Mark FitzGerald¹⁷, João A Fonseca¹⁸, Susanne Hansen¹⁹, Liam G Heaney²⁰, Enrico Heffler¹³, Mark Hew²¹, Takashi Iwanaga²², Daniel J Jackson²³, Janwillem W H Kocks²⁴, Maria Kallieri²⁵, Hsin-Kuo Bruce Ko²⁶, Mariko Siyue Koh²⁷, Désirée Larenas-Linnemann²⁸, Lauri A Lehtimäki²⁹, Stelios Loukides²⁵, Njira Lugogo³⁰, Jorge Maspero³¹, Andriana I Papaioannou²⁵, Luis Perez-de-Llano³², Paulo Márcio Pitrez³³, Todor A Popov³⁴, Linda M Rasmussen³⁵, Chin Kook Rhee³⁶, Mohsen Sadatsafavi³⁷, Johannes Schmid³⁸, Salman Siddiqui³⁹, Camille Taillé⁴⁰, Christian Taube⁴¹, Carlos A Torres-Duque⁴², Charlotte Ulrik⁴³, John W Upham⁴⁴, Eileen Wang⁴⁵, Michael E Wechsler⁴⁶, Lakmini Bulathsinhala⁴, Victoria Carter⁴, Isha Chaudhry⁴, Neva Eleangovan⁴, Naeimeh Hosseini⁴, Mari-Anne Rowlands⁴, David B Price⁴⁷, Job F M van Boven⁴⁸

Affiliations

¹ Respiratory Research Unit, Copenhagen University Hospital-Bispebjerg, Copenhagen, Denmark.
² UK Severe Asthma Network and National Registry, Royal Brompton and Harefield Hospitals, London, United Kingdom.
³ AstraZeneca, Gaithersburg, Md.
⁴ Optimum Patient Care, Cambridge, United Kingdom; Observational and Pragmatic Research Institute, Singapore, Singapore.
⁵ AstraZeneca, Cambridge, United Kingdom.
⁶ Al-Rashed Allergy Center, Ministry of Health, Microbiology Department, Faculty of Medicine, Kuwait University, Kuwait.
⁷ Department of Pulmonology, King Fahad Medical City, Riyadh, Saudi Arabia.
⁸ Department of Pulmonology, University of Tartu and Lung Clinic, Tartu University Hospital, Tartu, Estonia.
⁹ Department of Pulmonology, N.I. Pirogov Russian State National Research Medical University, Moscow, Russian Federation.
¹⁰ Department of Respiratory Medicine and Sleep, Landspitali, The National University Hospital of Iceland, Reykjavik, Iceland.
¹¹ PhyMedExp, University of Montpellier, CNRS, INSERM, CHU Montpellier, Montpellier, France.
¹² UK Severe Asthma Network and National Registry, Queen's University Belfast, Belfast, Northern Ireland.
¹³ Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
¹⁴ Medical University-Sofia, Faculty of Public Health, Sofia, Bulgaria.
¹⁵ Son Espases University Hospital-IdISBa-Ciberes, Mallorca, Spain.
¹⁶ Clinical Research Centre, Smurfit Building Beaumont Hospital, Department of Respiratory Medicine, RCSI, Dublin, Ireland.
¹⁷ Centre for Lung Health, Vancouver, British Columbia, Canada.
¹⁸ Health Information and Decision Sciences Department (MEDCIDS) and Center for Health Technology and Services Research (CINTESIS), Faculty of Medicine of University of Porto, Porto, Portugal.
¹⁹ Respiratory Research Unit, Copenhagen University Hospital-Bispebjerg, Copenhagen, Denmark; Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
²⁰ Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, Northern Ireland.
²¹ Allergy, Asthma, and Clinical Immunology Service, Alfred Health, Melbourne, Victoria, Australia; Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
²² Center for General Medical Education and Clinical Training, Kindai University Hospital, Osakasayama, Japan.
²³ UK Severe Asthma Network and National Registry, Guy's and St Thomas' NHS Trust, London, United Kingdom; School of Immunology and Microbial Sciences, King's College London, London, United Kingdom.
²⁴ Observational and Pragmatic Research Institute, Singapore, Singapore; General Practitioners Research Institute, Groningen, The Netherlands; Groningen Research Institute Asthma and COPD, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; Department of Pulmonology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
²⁵ Second Respiratory Medicine Department, National and Kapodistrian University of Athens Medical School, Attikon University Hospital, Athens, Greece.
²⁶ Taipei Veterans General Hospital, Taipei, Taiwan, Republic of China.
²⁷ Respiratory and Critical Care Medicine, Singapore General Hospital, Singapore; SingHealth Duke-NUS Lung Centre, Duke-NUS Medical School, Singapore.
²⁸ Directora Centro de Excelencia en Asma y Alergia, Hospital Médica Sur, Ciudad de México, Mexico City, Mexico.
²⁹ Allergy Centre, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
³⁰ Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, Mich.
³¹ Clinical Research for Allergy and Respiratory Medicine, CIDEA Foundation, Buenos Aires, Argentina; University Career of Specialists in Allergy and Clinical Immunology at the Buenos Aires University School of Medicine, Buenos Aires, Argentina.
³² Department of Respiratory Medicine, Hospital Universitario Lucus Augusti, Lugo, Spain.
³³ Hospital Moinhos de Vento, Porto Alegre, Brazil and Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil.
³⁴ University Hospital Sv Ivan Rilski, Sofia, Bulgaria.
³⁵ Allergy Clinic, Copenhagen University Hospital-Gentofte, Hellerup, Denmark.
³⁶ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
³⁷ Respiratory Evaluation Sciences Program, Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia, Canada.
³⁸ University Hospital of Aarhus, Aarhus, Denmark.
³⁹ University of Leicester, Department of Respiratory Sciences and NIHR Leicester Biomedical Research Centre, Leicester, United Kingdom.
⁴⁰ Department of Respiratory Diseases, Bichat Hospital, AP-HP Nord-Université de Paris, Paris, France.
⁴¹ Department of Pulmonary Medicine, University Medical Center Essen-Ruhrlandklinik, Essen, Germany.
⁴² Departamento de Investigación, Fundación Neumológica Colombiana, Bogotá, Colombia.
⁴³ Respiratory Research Unit, Department of Respiratory Medicine, Copenhagen University Hospital-Hvidovre, Hvidovre, Denmark.
⁴⁴ Diamantina Institute and PA-Southside Clinical Unit, The University of Queensland, Brisbane, Queensland, Australia.
⁴⁵ Division of Allergy and Clinical Immunology, Department of Medicine, National Jewish Health, Denver, Colo; Division of Allergy and Clinical Immunology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colo.
⁴⁶ NJH Cohen Family Asthma Institute, Department of Medicine, National Jewish Health, Denver, Colo.
⁴⁷ Optimum Patient Care, Cambridge, United Kingdom; Observational and Pragmatic Research Institute, Singapore, Singapore; Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, United Kingdom. Electronic address: dprice@opri.sg.
⁴⁸ Department of Clinical Pharmacy and Pharmacology, Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.

PMID: 34990866
DOI: 10.1016/j.jaip.2021.12.027

Free article

Review

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

Celeste M Porsbjerg et al. J Allergy Clin Immunol Pract. 2022 May.

Free article

. 2022 May;10(5):1202-1216.e23.

doi: 10.1016/j.jaip.2021.12.027. Epub 2022 Jan 3.

Authors

Affiliations

¹ Respiratory Research Unit, Copenhagen University Hospital-Bispebjerg, Copenhagen, Denmark.
² UK Severe Asthma Network and National Registry, Royal Brompton and Harefield Hospitals, London, United Kingdom.
³ AstraZeneca, Gaithersburg, Md.
⁴ Optimum Patient Care, Cambridge, United Kingdom; Observational and Pragmatic Research Institute, Singapore, Singapore.
⁵ AstraZeneca, Cambridge, United Kingdom.
⁶ Al-Rashed Allergy Center, Ministry of Health, Microbiology Department, Faculty of Medicine, Kuwait University, Kuwait.
⁷ Department of Pulmonology, King Fahad Medical City, Riyadh, Saudi Arabia.
⁸ Department of Pulmonology, University of Tartu and Lung Clinic, Tartu University Hospital, Tartu, Estonia.
⁹ Department of Pulmonology, N.I. Pirogov Russian State National Research Medical University, Moscow, Russian Federation.
¹⁰ Department of Respiratory Medicine and Sleep, Landspitali, The National University Hospital of Iceland, Reykjavik, Iceland.
¹¹ PhyMedExp, University of Montpellier, CNRS, INSERM, CHU Montpellier, Montpellier, France.
¹² UK Severe Asthma Network and National Registry, Queen's University Belfast, Belfast, Northern Ireland.
¹³ Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
¹⁴ Medical University-Sofia, Faculty of Public Health, Sofia, Bulgaria.
¹⁵ Son Espases University Hospital-IdISBa-Ciberes, Mallorca, Spain.
¹⁶ Clinical Research Centre, Smurfit Building Beaumont Hospital, Department of Respiratory Medicine, RCSI, Dublin, Ireland.
¹⁷ Centre for Lung Health, Vancouver, British Columbia, Canada.
¹⁸ Health Information and Decision Sciences Department (MEDCIDS) and Center for Health Technology and Services Research (CINTESIS), Faculty of Medicine of University of Porto, Porto, Portugal.
¹⁹ Respiratory Research Unit, Copenhagen University Hospital-Bispebjerg, Copenhagen, Denmark; Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
²⁰ Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, Northern Ireland.
²¹ Allergy, Asthma, and Clinical Immunology Service, Alfred Health, Melbourne, Victoria, Australia; Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
²² Center for General Medical Education and Clinical Training, Kindai University Hospital, Osakasayama, Japan.
²³ UK Severe Asthma Network and National Registry, Guy's and St Thomas' NHS Trust, London, United Kingdom; School of Immunology and Microbial Sciences, King's College London, London, United Kingdom.
²⁴ Observational and Pragmatic Research Institute, Singapore, Singapore; General Practitioners Research Institute, Groningen, The Netherlands; Groningen Research Institute Asthma and COPD, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; Department of Pulmonology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
²⁵ Second Respiratory Medicine Department, National and Kapodistrian University of Athens Medical School, Attikon University Hospital, Athens, Greece.
²⁶ Taipei Veterans General Hospital, Taipei, Taiwan, Republic of China.
²⁷ Respiratory and Critical Care Medicine, Singapore General Hospital, Singapore; SingHealth Duke-NUS Lung Centre, Duke-NUS Medical School, Singapore.
²⁸ Directora Centro de Excelencia en Asma y Alergia, Hospital Médica Sur, Ciudad de México, Mexico City, Mexico.
²⁹ Allergy Centre, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
³⁰ Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, Mich.
³¹ Clinical Research for Allergy and Respiratory Medicine, CIDEA Foundation, Buenos Aires, Argentina; University Career of Specialists in Allergy and Clinical Immunology at the Buenos Aires University School of Medicine, Buenos Aires, Argentina.
³² Department of Respiratory Medicine, Hospital Universitario Lucus Augusti, Lugo, Spain.
³³ Hospital Moinhos de Vento, Porto Alegre, Brazil and Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil.
³⁴ University Hospital Sv Ivan Rilski, Sofia, Bulgaria.
³⁵ Allergy Clinic, Copenhagen University Hospital-Gentofte, Hellerup, Denmark.
³⁶ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
³⁷ Respiratory Evaluation Sciences Program, Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia, Canada.
³⁸ University Hospital of Aarhus, Aarhus, Denmark.
³⁹ University of Leicester, Department of Respiratory Sciences and NIHR Leicester Biomedical Research Centre, Leicester, United Kingdom.
⁴⁰ Department of Respiratory Diseases, Bichat Hospital, AP-HP Nord-Université de Paris, Paris, France.
⁴¹ Department of Pulmonary Medicine, University Medical Center Essen-Ruhrlandklinik, Essen, Germany.
⁴² Departamento de Investigación, Fundación Neumológica Colombiana, Bogotá, Colombia.
⁴³ Respiratory Research Unit, Department of Respiratory Medicine, Copenhagen University Hospital-Hvidovre, Hvidovre, Denmark.
⁴⁴ Diamantina Institute and PA-Southside Clinical Unit, The University of Queensland, Brisbane, Queensland, Australia.
⁴⁵ Division of Allergy and Clinical Immunology, Department of Medicine, National Jewish Health, Denver, Colo; Division of Allergy and Clinical Immunology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colo.
⁴⁶ NJH Cohen Family Asthma Institute, Department of Medicine, National Jewish Health, Denver, Colo.
⁴⁷ Optimum Patient Care, Cambridge, United Kingdom; Observational and Pragmatic Research Institute, Singapore, Singapore; Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, United Kingdom. Electronic address: dprice@opri.sg.
⁴⁸ Department of Clinical Pharmacy and Pharmacology, Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.

PMID: 34990866
DOI: 10.1016/j.jaip.2021.12.027

Erratum in

Corrigendum.
[No authors listed] [No authors listed] J Allergy Clin Immunol Pract. 2022 Jun;10(6):1673. doi: 10.1016/j.jaip.2022.05.001. J Allergy Clin Immunol Pract. 2022. PMID: 35688511 No abstract available.

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 marketing authorization specifications, a higher score reflects easier access.

Results: Biologic prescription criteria differed substantially across 28 countries from five continents. Blood eosinophil count thresholds (usually ≥300 cells/μL) and exacerbations were key requirements for anti-IgE/anti-IL-5/5R prescriptions in around 80% of licensed countries. Most countries (40% for dupilumab to 54% for mepolizumab) require two or more moderate or severe exacerbations, whereas numbers ranged from none to four. Moreover, 0% (for reslizumab) to 21% (for omalizumab) of countries 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 European Medicines Agency reference BACS. For reslizumab, all countries scored lower.

Conclusions: Although some differences were expected in country-specific biologic prescription criteria and ease of access, the substantial differences found in the current study present a challenge to implementing precision medicine across the world.

Keywords: Biologics access; Biologics eligibility; Severe asthma.

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

Affiliations

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

Authors

Affiliations

Erratum in

Abstract

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MeSH terms

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LinkOut - more resources

Full Text Sources

Medical

Miscellaneous