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

Autor: Meghoufel, Z, Cherifi, F, Boukra, A, Terki, F, Porsbjerg, Celeste, Menzies-Gow, Andrew, Tran, Trung, Murray, Ruth, Unni, Bindhu, Audrey Ang, Shi Ling, Alacqua, Marianna, Al-Ahmad, Mona, Al-Lehebi, Riyad, Altraja, Alan, Belevskiy, Andrey, Björnsdóttir, Unnur, Bourdin, Arnaud, Busby, John, Canonica, G. Walter, Christoff, George, Cosio, Borja, Costello, Richard, FitzGerald, J. Mark, Fonseca, João, Hansen, Susanne, Heaney, Liam, Heffler, Enrico, Hew, Mark, Iwanaga, Takashi, Jackson, David, Kocks, Janwillem W.H., Kallieri, Maria, Bruce Ko, Hsin-Kuo, Koh, Mariko Siyue, Larenas-Linnemann, Désirée, Lehtimäki, Lauri, Loukides, Stelios, Lugogo, Njira, Maspero, Jorge, Papaioannou, Andriana, Perez-de-Llano, Luis, Pitrez, Paulo Márcio, Popov, Todor, Rasmussen, Linda, Rhee, Chin Kook, Sadatsafavi, Mohsen, Schmid, Johannes, Siddiqui, Salman, Taillé, Camille, Taube, Christian, Torres-Duque, Carlos, Ulrik, Charlotte, Upham, John, Wang, Eileen, Wechsler, Michael, Bulathsinhala, Lakmini, Carter, Victoria, Chaudhry, Isha, Eleangovan, Neva, Hosseini, Naeimeh, Rowlands, Mari-Anne, Price, David, van Boven, Job FM.
Přispěvatelé: Groningen Research Institute for Asthma and COPD (GRIAC), Value, Affordability and Sustainability (VALUE), Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Journal of Allergy and Clinical Immunology: In Practice, 10(5), 1202-1216.e23. American Academy of Allergy, Asthma and Immunology
Journal of Allergy and Clinical Immunology: In Practice
Journal of Allergy and Clinical Immunology: In Practice, Elsevier, 2022, 33 (39), pp.395701. ⟨10.1016/j.jaip.2021.12.027⟩
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, Fonseca, J A, Hansen, S, Heaney, L G, Heffler, E, Hew, M, Iwanaga, T, Jackson, D J, Kocks, J W H, Kallieri, M, Bruce Ko, H-K, Koh, M S, Larenas-Linnemann, D, Lehtimäki, L A, Loukides, S, Lugogo, N, Maspero, J, Papaioannou, A I, Perez-de-Llano, L, Pitrez, P M, Popov, T A, Rasmussen, L M, Rhee, C K, Sadatsafavi, M, Schmid, J, Siddiqui, S, Taillé, C, Taube, C, Torres-Duque, C A, Ulrik, C, Upham, J W, Wang, E, Wechsler, M E, Bulathsinhala, L, Carter, V, Chaudhry, I, Eleangovan, N, Hosseini, N, Rowlands, M-A, Price, D & 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, vol. 10, no. 5, pp. 1202-1216.e23 . https://doi.org/10.1016/j.jaip.2021.12.027
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, Fonseca, J A, Hansen, S, Heaney, L G, Heffler, E, Hew, M, Iwanaga, T, Jackson, D J, Kocks, J W H, Kallieri, M, Bruce Ko, H K, Koh, M S, Larenas-Linnemann, D, Lehtimäki, L A, Loukides, S, Lugogo, N, Maspero, J, Papaioannou, A I, Perez-de-Llano, L, Pitrez, P M, Popov, T A, Rasmussen, L M, Rhee, C K, Sadatsafavi, M, Schmid, J, Siddiqui, S, Taillé, C, Taube, C, Torres-Duque, C A, Ulrik, C, Upham, J W, Wang, E, Wechsler, M E, Bulathsinhala, L, Carter, V, Chaudhry, I, Eleangovan, N, Hosseini, N, Rowlands, M A, Price, D B & 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, vol. 10, no. 5, pp. 1202-1216.e23 . https://doi.org/10.1016/j.jaip.2021.12.027
1216.e23
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, Fonseca, J A, Heaney, L G, Heffler, E, Hew, M, Iwanaga, T, Jackson, D J, Kocks, J W H, Kallieri, M, Bruce Ko, H, Koh, M S, Larenas-linnemann, D, Lehtimäki, L A, Loukides, S, Lugogo, N, Maspero, J, Papaioannou, A I, Perez-de-llano, L, Pitrez, P M, Popov, T A, Rasmussen, L M, Rhee, C K, Sadatsafavi, M, Schmid, J, Siddiqui, S, Taillé, C, Taube, C, Torres-duque, C A, Ulrik, C, Upham, J W, Wang, E, Wechsler, M E, Bulathsinhala, L, Carter, V, Chaudhry, I, Eleangovan, N, Hosseini, N, Rowlands, M, Price, D B & 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, vol. 10, no. 5, pp. 1202-1216.e23 . https://doi.org/10.1016/j.jaip.2021.12.027
ISSN: 2213-2198
Popis: 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.
Databáze: OpenAIRE
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