Barriers and facilitators to early access of bedaquiline and delamanid for MDR-TB: a mixed-methods study
Objective: To inform improvements in early access, we explored experiences of providers and advocates in accessing BDQ and DLM before the end of 2015 using a mixed-methods design.
Design: We examined barriers and facilitators to early access through an electronic survey. Barriers and facilitators were classified as occurring at the manufacturer- or country-level. We identified themes using inductive content analysis and illustrated themes through case studies.
Results: We analysed 41 survey responses from 36 respondents reporting on 22 countries; early access was attempted in 30 (73%) survey responses. Eligibility restrictions (11/30, 37%) and complicated and slow processes (8/30, 27%) were manufacturer-level barriers; access to companion drugs (10, 33%) and importation difficulties (4, 13%) were country-level barriers. Previous experience with manufacturer (3/30, 10%) and country processes (2/30, 7%) facilitated access. Eight case studies show the human impact of barriers and facilitators.
Conclusion: Manufacturers and countries should develop transparent processes to permit early access, particularly for diseases that largely affect the poor, such as MDR-TB. Developers should plan for this need and rapidly register drugs with proven benefit, prioritizing high-burden settings.
Document Type: Research Article
Affiliations: 1: Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA 2: Médecins Sans Frontières, Paris, France, Centre National de Référence des Mycobactéries et de la Résistance des Mycobactéries aux Antituberculeux, Bactériologie-Hygiène, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Assistance publique Hopitaux de Paris, Paris, France, Team E13 (Bactériologie), Centre d’Immunologie et des Maladies Infectieuses, Sorbonne Université, Université Pierre et Marie Curie, Université Paris 06, Centre de Recherche 7, Institut national de la Santé et de la Recherche médicale Unité 1135, Paris, France 3: Médecins Sans Frontières, Paris, France 4: Sanatorium, Centre Hospitalier de Bligny, Briissous-Forges, France 5: Treatment Action Group, New York, New York, USA
Publication date: March 21, 2019
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