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; 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

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, 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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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 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 language	English
Pages (from-to)	1202-1216.e23
Journal	The Journal of Allergy and Clinical Immunology: In Practice
Volume	10
Issue number	5
DOIs	https://doi.org/10.1016/j.jaip.2021.12.027
Publication status	Published - 05 May 2022

Bibliographical note

Keywords

Biologics access
Biologics eligibility
Severe asthma

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Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma
Copyright 2022 the authors. This is an open access article published under a Creative Commons Attribution-NonCommercial-NoDerivs License (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits distribution and reproduction for non-commercial purposes, provided the author and source are cited.
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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. (2022). Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma. The Journal of Allergy and Clinical Immunology: In Practice, 10(5), 1202-1216.e23. https://doi.org/10.1016/j.jaip.2021.12.027

Porsbjerg, Celeste M ; Menzies-Gow, Andrew N ; Tran, Trung N ; Murray, Ruth B ; Unni, Bindhu ; Audrey Ang, Shi Ling ; Alacqua, Marianna ; Al-Ahmad, Mona ; Al-Lehebi, Riyad ; Altraja, Alan ; Belevskiy, Andrey S ; Björnsdóttir, Unnur S ; Bourdin, Arnaud ; Busby, John ; Canonica, G Walter ; Christoff, George C ; Cosio, Borja G ; Costello, Richard W ; FitzGerald, J Mark ; Fonseca, João A ; Hansen, Susanne ; Heaney, Liam G ; Heffler, Enrico ; Hew, Mark ; Iwanaga, Takashi ; Jackson, David J ; Kocks, Janwillem W H ; Kallieri, Maria ; Bruce Ko, Hsin-Kuo ; Koh, Mariko Siyue ; Larenas-Linnemann, Désirée ; Lehtimäki, Lauri A ; Loukides, Stelios ; Lugogo, Njira ; Maspero, Jorge ; Papaioannou, Andriana I ; Perez-de-Llano, Luis ; Pitrez, Paulo Márcio ; Popov, Todor A ; Rasmussen, Linda M ; Rhee, Chin Kook ; Sadatsafavi, Mohsen ; Schmid, Johannes ; Siddiqui, Salman ; Taillé, Camille ; Taube, Christian ; Torres-Duque, Carlos A ; Ulrik, Charlotte ; Upham, John W ; Wang, Eileen ; Wechsler, Michael E ; Bulathsinhala, Lakmini ; Carter, Victoria ; Chaudhry, Isha ; Eleangovan, Neva ; Hosseini, Naeimeh ; Rowlands, Mari-Anne ; Price, David ; van Boven, Job Fm. / Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma. In: The Journal of Allergy and Clinical Immunology: In Practice. 2022 ; Vol. 10, No. 5. pp. 1202-1216.e23.

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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 (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.",

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, {David 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 Mari-Anne Rowlands and David Price and {van Boven}, {Job Fm}",

note = "Copyright {\textcopyright} 2021. Published by Elsevier Inc.",

year = "2022",

month = may,

day = "5",

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

language = "English",

volume = "10",

pages = "1202--1216.e23",

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

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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, H-K, 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, M-A, Price, D & van Boven, JF 2022, 'Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma', The 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

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

In: The Journal of Allergy and Clinical Immunology: In Practice, Vol. 10, No. 5, 05.05.2022, p. 1202-1216.e23.

Research output: Contribution to journal › Article › peer-review

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, David 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

AU - van Boven, Job Fm

PY - 2022/5/5

Y1 - 2022/5/5

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 (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.

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 (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.

KW - Biologics access

KW - Biologics eligibility

KW - Severe asthma

U2 - 10.1016/j.jaip.2021.12.027

DO - 10.1016/j.jaip.2021.12.027

M3 - Article

C2 - 34990866

VL - 10

SP - 1202-1216.e23

JO - The Journal of Allergy and Clinical Immunology: In Practice

JF - The Journal of Allergy and Clinical Immunology: In Practice

SN - 2213-2198

IS - 5

ER -

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

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