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

被引：50

作者：

Porsbjerg, Celeste M. ^{[1
]}

Menzies-Gow, Andrew N. ^{[2
]}

Tran, Trung N. ^{[3
]}

Murray, Ruth B. ^{[4
,5
]}

Unni, Bindhu ^{[4
,5
]}

Ang, Shi Ling Audrey ^{[4
,5
]}

Alacqua, Marianna ^{[6
]}

Al-Ahmad, Mona ^{[7
]}

Al-Lehebi, Riyad ^{[8
]}

Altraja, Alan ^{[9
,10
]}

Belevskiy, Andrey S. ^{[11
]}

Bjornsdottir, Unnur S. ^{[12
]}

Bourdin, Arnaud ^{[13
]}

Busby, John ^{[14
]}

Canonica, G. Walter ^{[15
,16
]}

Christoff, George C. ^{[17
]}

Cosio, Borja G. ^{[18
]}

Costello, Richard W. ^{[19
]}

FitzGerald, J. Mark ^{[20
]}

Fonseca, Joao A. ^{[21
,22
]}

Hansen, Susanne ^{[1
,23
]}

Heaney, Liam G. ^{[24
]}

Heffler, Enrico ^{[15
,16
]}

Hew, Mark ^{[25
,26
]}

Iwanaga, Takashi ^{[27
]}

Jackson, David J. ^{[28
,29
]}

Kocks, Janwillem W. H. ^{[5
,30
,31
,32
]}

Kallieri, Maria ^{[33
]}

Ko, Hsin-Kuo Bruce ^{[34
]}

Koh, Mariko Siyue ^{[35
,36
]}

Larenas-Linnemann, Desiree ^{[37
]}

Lehtimaki, Lauri A. ^{[38
,39
]}

Loukides, Stelios ^{[33
]}

Lugogo, Njira ^{[40
]}

Maspero, Jorge ^{[41
,42
]}

Papaioannou, Andriana, I ^{[33
]}

Perez-de-Llano, Luis ^{[43
]}

Pitrez, Paulo Marcio ^{[44
,45
]}

Popov, Todor A. ^{[46
]}

Rasmussen, Linda M. ^{[47
]}

Rhee, Chin Kook ^{[48
]}

Sadatsafavi, Mohsen ^{[49
]}

Schmid, Johannes ^{[50
]}

Siddiqui, Salman ^{[51
,52
]}

Taille, Camille ^{[53
]}

Taube, Christian ^{[54
]}

Torres-Duque, Carlos A. ^{[55
]}

Ulrik, Charlotte ^{[56
]}

Upham, John W. ^{[57
,58
]}

Wang, Eileen ^{[59
,60
]}

机构：

[1] Copenhagen Univ Hosp Bispebjerg, Resp Res Unit, Copenhagen, Denmark

[2] Royal Brompton & Harefield Hosp, UK Severe Asthma Network & Natl Registry, London, England

[3] AstraZeneca, Gaithersburg, MD USA

[4] Optimum Patient Care, Cambridge, England

[5] Observat & Pragmat Res Inst, 22 Sin Ming Lane,06 Midview City, Singapore 573969, Singapore

[6] AstraZeneca, Cambridge, England

[7] Kuwait Univ, Fac Med, Al Rashed Allergy Ctr, Microbiol Dept,Minist Hlth, Kuwait, Kuwait

[8] King Fahad Med City, Dept Pulmonol, Riyadh, Saudi Arabia

[9] Univ Tartu, Dept Pulmonol, Tartu, Estonia

[10] Tartu Univ Hosp, Lung Clin, Tartu, Estonia

[11] NI Pirogov Russian State Natl Res Med Univ, Dept Pulmonol, Moscow, Russia

[12] Natl Univ Hosp Iceland, Dept Resp Med & Sleep, Landspitali, Reykjavik, Iceland

[13] Univ Montpellier, CHU Montpellier, INSERM, CNRS,PhyMedExp, Montpellier, France

[14] Queens Univ Belfast, UK Severe Asthma Network & Natl Registry, Belfast, Antrim, North Ireland

[15] Humanitas Clin & Res Ctr IRCCS, Personalized Med Asthma & Allergy, Milan, Italy

[16] Humanitas Univ, Dept Biomed Sci, Milan, Italy

[17] Med Univ Sofia, Fac Publ Hlth, Sofia, Bulgaria

[18] Son Espases Univ Hosp IdISBa Ciberes, Mallorca, Spain

[19] Smurfit Bldg Beaumont Hosp, Dept Resp Med, RCSI, Clin Res Ctr, Dublin, Ireland

[20] Ctr Lung Hlth, Vancouver, BC, Canada

[21] Univ Porto, Hlth Informat & Decis Sci Dept MEDCIDS, Fac Med, Porto, Portugal

[22] Univ Porto, Ctr Hlth Technol & Serv Res CINTESIS, Fac Med, Porto, Portugal

[23] Bispebjerg & Frederiksberg Hosp, Ctr Clin Res & Prevent, Copenhagen, Denmark

[24] Queens Univ Belfast, Wellcome Wolfson Ctr Expt Med, Belfast, Antrim, North Ireland

[25] Alfred Hlth, Allergy Asthma & Clin Immunol Serv, Melbourne, Vic, Australia

[26] Monash Univ, Publ Hlth & Prevent Med, Melbourne, Vic, Australia

[27] Kindai Univ Hosp, Ctr Gen Med Educ & Clin Training, Osakasayama, Japan

[28] Guys & St Thomas NHS Trust, UK Severe Asthma Network & Natl Registry, London, England

[29] Kings Coll London, Sch Immunol & Microbial Sci, London, England

[30] Gen Practitioners Res Inst, Groningen, Netherlands

[31] Univ Groningen, Univ Med Ctr Groningen, Groningen Res Inst Asthma & COPD, Groningen, Netherlands

[32] Univ Groningen, Univ Med Ctr Groningen, Dept Pulmonol, Groningen, Netherlands

[33] Natl & Kapodistrian Univ Athens, Attikon Univ Hosp, Resp Med Dept 2, Med Sch, Athens, Greece

[34] Taipei Vet Gen Hosp, Taipei, Taiwan

[35] Singapore Gen Hosp, Resp & Crit Care Med, Singapore, Singapore

[36] Duke NUS Med Sch, SingHlth Duke NUS Lung Ctr, Singapore, Singapore

[37] Hosp Med Sur, Directora Ctr Excelencia Asma & Alergia, Mexico City, DF, Mexico

[38] Tampere Univ, Tampere Univ Hosp, Allergy Ctr, Tampere, Finland

[39] Tampere Univ, Fac Med & Hlth Technol, Tampere, Finland

[40] Univ Michigan, Dept Med, Div Pulm & Crit Care Med, Ann Arbor, MI 48109 USA

[41] CIDEA Fdn, Clin Res Allergy & Resp Med, Buenos Aires, DF, Argentina

[42] Buenos Aires Univ, Univ Career Specialists Allergy & Clin Immunol, Sch Med, Buenos Aires, DF, Argentina

[43] Hosp Univ Lucus Augusti, Dept Resp Med, Lugo, Spain

[44] Hosp Moinhos Vento, Porto Alegre, RS, Brazil

[45] Pontificia Univ Catolica Rio Grande do Sul PUCRS, Porto Alegre, RS, Brazil

[46] Univ Hosp Sv Ivan Rilski, Sofia, Bulgaria

[47] Copenhagen Univ Hosp Gentofte, Allergy Clin, Hellerup, Denmark

[48] Catholic Univ Korea, Coll Med, Dept Internal Med, Div Pulm & Crit Care Med,Seoul St Marys Hosp, Seoul, South Korea

[49] Univ British Columbia, Fac Pharmaceut Sci, Resp Evaluat Sci Program, Vancouver, BC, Canada

[50] Univ Hosp Aarhus, Aarhus, Denmark

来源：

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE | 2022年 / 10卷 / 05期

关键词：

Severe asthma; Biologics access; Biologics eligibility; MULTICENTER; MEPOLIZUMAB;

D O I：

10.1016/j.jaip.2021.12.027

中图分类号：

R392 [医学免疫学];

学科分类号：

100102 ;

摘要：

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/mu L) 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. (C) 2022 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology.

引用

页码：1202 / +

页数：38

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