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. Fonseca; Susanne Hansen; Liam G. Heaney; Enrico Heffler; Mark Hew; Takashi Iwanaga; Daniel 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 B. Price; Job F.M. van Boven

doi:10.1016/j.jaip.2021.12.027

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, Daniel 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 B. Price, Job F.M. van Boven

Division of Pulmonology

Research output: Contribution to journal › Review article › peer-review

30 Scopus citations

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.

Original language	English
Pages (from-to)	1202-1216.e23
Journal	Journal of Allergy and Clinical Immunology: In Practice
Volume	10
Issue number	5
DOIs	https://doi.org/10.1016/j.jaip.2021.12.027
State	Published - May 2022

Bibliographical note

Publisher Copyright:
© 2022 The Authors

Keywords

Biologics access
Biologics eligibility
Severe asthma

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10.1016/j.jaip.2021.12.027

Cite this

Porsbjerg, C. M., Menzies-Gow, A. N., Tran, T. N., Murray, R. B., Unni, B., Audrey Ang, S. L., Alacqua, M., Al-Ahmad, M., Al-Lehebi, R., Altraja, A., Belevskiy, A. S., Björnsdóttir, U. S., Bourdin, A., Busby, J., Canonica, G. W., Christoff, G. C., Cosio, B. G., Costello, R. W., FitzGerald, J. M., ... van Boven, J. F. M. (2022). Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma. Journal of Allergy and Clinical Immunology: In Practice, 10(5), 1202-1216.e23. https://doi.org/10.1016/j.jaip.2021.12.027

@article{2e87756577f340f2b29fdf4598c78695,

title = "Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma",

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",

author = "Porsbjerg, {Celeste M.} and Menzies-Gow, {Andrew N.} and Tran, {Trung N.} and Murray, {Ruth B.} and Bindhu Unni and {Audrey Ang}, {Shi Ling} and Marianna Alacqua and Mona Al-Ahmad and Riyad Al-Lehebi and Alan Altraja and Belevskiy, {Andrey S.} and Bj{\"o}rnsd{\'o}ttir, {Unnur S.} and Arnaud Bourdin and John Busby and Canonica, {G. Walter} and Christoff, {George C.} and Cosio, {Borja G.} and Costello, {Richard W.} and FitzGerald, {J. Mark} and Fonseca, {Jo{\~a}o A.} and Susanne Hansen and Heaney, {Liam G.} and Enrico Heffler and Mark Hew and Takashi Iwanaga and Jackson, {Daniel J.} and Kocks, {Janwillem W.H.} and Maria Kallieri and {Bruce Ko}, {Hsin Kuo} and Koh, {Mariko Siyue} and D{\'e}sir{\'e}e Larenas-Linnemann and Lehtim{\"a}ki, {Lauri A.} and Stelios Loukides and Njira Lugogo and Jorge Maspero and Papaioannou, {Andriana I.} and Luis Perez-de-Llano and Pitrez, {Paulo M{\'a}rcio} and Popov, {Todor A.} and Rasmussen, {Linda M.} and Rhee, {Chin Kook} and Mohsen Sadatsafavi and Johannes Schmid and Salman Siddiqui and Camille Taill{\'e} and Christian Taube and Torres-Duque, {Carlos A.} and Charlotte Ulrik and Upham, {John W.} and Eileen Wang and Wechsler, {Michael E.} and Lakmini Bulathsinhala and Victoria Carter and Isha Chaudhry and Neva Eleangovan and Naeimeh Hosseini and Rowlands, {Mari Anne} and Price, {David B.} and {van Boven}, {Job F.M.}",

note = "Publisher Copyright: {\textcopyright} 2022 The Authors",

year = "2022",

month = may,

doi = "10.1016/j.jaip.2021.12.027",

language = "English",

volume = "10",

pages = "1202--1216.e23",

journal = "Journal of Allergy and Clinical Immunology: In Practice",

issn = "2213-2198",

publisher = "Elsevier",

number = "5",

}

Porsbjerg, CM, Menzies-Gow, AN, Tran, TN, Murray, RB, Unni, B, Audrey Ang, SL, Alacqua, M, Al-Ahmad, M, Al-Lehebi, R, Altraja, A, Belevskiy, AS, Björnsdóttir, US, Bourdin, A, Busby, J, Canonica, GW, Christoff, GC, Cosio, BG, Costello, RW, FitzGerald, JM, Fonseca, JA, Hansen, S, Heaney, LG, Heffler, E, Hew, M, Iwanaga, T, Jackson, DJ, Kocks, JWH, Kallieri, M, Bruce Ko, HK, Koh, MS, Larenas-Linnemann, D, Lehtimäki, LA, Loukides, S, Lugogo, N, Maspero, J, Papaioannou, AI, Perez-de-Llano, L, Pitrez, PM, Popov, TA, Rasmussen, LM, Rhee, CK, Sadatsafavi, M, Schmid, J, Siddiqui, S, Taillé, C, Taube, C, Torres-Duque, CA, Ulrik, C, Upham, JW, Wang, E, Wechsler, ME, Bulathsinhala, L, Carter, V, Chaudhry, I, Eleangovan, N, Hosseini, N, Rowlands, MA, Price, DB & van Boven, JFM 2022, 'Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma', Journal of Allergy and Clinical Immunology: In Practice, vol. 10, no. 5, pp. 1202-1216.e23. https://doi.org/10.1016/j.jaip.2021.12.027

TY - JOUR

T1 - Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma

AU - Porsbjerg, Celeste M.

AU - Menzies-Gow, Andrew N.

AU - Tran, Trung N.

AU - Murray, Ruth B.

AU - Unni, Bindhu

AU - Audrey Ang, Shi Ling

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 - Canonica, G. Walter

AU - Christoff, George C.

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, Daniel J.

AU - Kocks, Janwillem W.H.

AU - Kallieri, Maria

AU - Bruce Ko, Hsin Kuo

AU - Koh, Mariko Siyue

AU - Larenas-Linnemann, Désirée

AU - Lehtimäki, Lauri A.

AU - Loukides, Stelios

AU - Lugogo, Njira

AU - Maspero, Jorge

AU - Papaioannou, Andriana I.

AU - Perez-de-Llano, Luis

AU - Pitrez, Paulo Márcio

AU - Popov, Todor A.

AU - Rasmussen, Linda M.

AU - Rhee, Chin Kook

AU - Sadatsafavi, Mohsen

AU - Schmid, Johannes

AU - Siddiqui, Salman

AU - Taillé, Camille

AU - Taube, Christian

AU - Torres-Duque, Carlos A.

AU - Ulrik, Charlotte

AU - Upham, John W.

AU - Wang, Eileen

AU - Wechsler, Michael E.

AU - Bulathsinhala, Lakmini

AU - Carter, Victoria

AU - Chaudhry, Isha

AU - Eleangovan, Neva

AU - Hosseini, Naeimeh

AU - Rowlands, Mari Anne

AU - Price, David B.

AU - van Boven, Job F.M.

PY - 2022/5

Y1 - 2022/5

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 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.

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 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.

KW - Biologics access

KW - Biologics eligibility

KW - Severe asthma

UR - http://www.scopus.com/inward/record.url?scp=85124182218&partnerID=8YFLogxK

U2 - 10.1016/j.jaip.2021.12.027

DO - 10.1016/j.jaip.2021.12.027

M3 - Review article

C2 - 34990866

AN - SCOPUS:85124182218

SN - 2213-2198

VL - 10

SP - 1202-1216.e23

JO - Journal of Allergy and Clinical Immunology: In Practice

JF - Journal of Allergy and Clinical Immunology: In Practice

IS - 5

ER -

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

Abstract

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Keywords

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