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

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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.; 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 B.; Van Boven, Job F.m.

I: The Journal of Allergy and Clinical Immunology: In Practice, Bind 10, Nr. 5, 2022, s. 1202-1216.e23.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Harvard

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, Heaney, LG, Heffler, E, Hew, M, Iwanaga, T, Jackson, DJ, Kocks, JWH, Kallieri, M, Bruce Ko, H, 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, Price, DB & Van Boven, JFM 2022, 'Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma', The Journal of Allergy and Clinical Immunology: In Practice, bind 10, nr. 5, s. 1202-1216.e23. https://doi.org/10.1016/j.jaip.2021.12.027

APA

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. The Journal of Allergy and Clinical Immunology: In Practice, 10(5), 1202-1216.e23. https://doi.org/10.1016/j.jaip.2021.12.027

Vancouver

Porsbjerg CM, Menzies-gow AN, Tran TN, Murray RB, Unni B, Audrey Ang SL o.a. Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma. The Journal of Allergy and Clinical Immunology: In Practice. 2022;10(5):1202-1216.e23. https://doi.org/10.1016/j.jaip.2021.12.027

Author

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. ; 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 B. ; Van Boven, Job F.m. / Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma. I: The Journal of Allergy and Clinical Immunology: In Practice. 2022 ; Bind 10, Nr. 5. s. 1202-1216.e23.

Bibtex

@article{1a5f7d3b239f45da9a2010dfe04f1c25,
title = "Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma",
abstract = "BackgroundRegulatory bodies have approved five biologics for severe asthma. However, regional differences in accessibility may limit the global potential for personalized medicine.ObjectiveTo compare global differences in ease of access to biologics.MethodsIn 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.ResultsBiologic 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.ConclusionsAlthough 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.",
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 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 Price, {David B.} and {Van Boven}, {Job F.m.}",
year = "2022",
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",
issn = "2213-2198",
publisher = "Elsevier",
number = "5",

}

RIS

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 - 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 B.

AU - Van Boven, Job F.m.

PY - 2022

Y1 - 2022

N2 - BackgroundRegulatory bodies have approved five biologics for severe asthma. However, regional differences in accessibility may limit the global potential for personalized medicine.ObjectiveTo compare global differences in ease of access to biologics.MethodsIn 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.ResultsBiologic 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.ConclusionsAlthough 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 - BackgroundRegulatory bodies have approved five biologics for severe asthma. However, regional differences in accessibility may limit the global potential for personalized medicine.ObjectiveTo compare global differences in ease of access to biologics.MethodsIn 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.ResultsBiologic 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.ConclusionsAlthough 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.

U2 - 10.1016/j.jaip.2021.12.027

DO - 10.1016/j.jaip.2021.12.027

M3 - Journal 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 -

ID: 321270707