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Open Access Barriers and facilitators to early access of bedaquiline and delamanid for MDR-TB: a mixed-methods study

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Setting: Phase II trials for bedaquiline (BDQ) and delamanid (DLM) were completed by 2011 and the drugs were approved by stringent regulatory authorities for the treatment of multidrug-resistant tuberculosis (MDR-TB) between 2012 and 2014. Manufacturers established ‘early access’ mechanisms to provide drugs before local registration.

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.
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Keywords: compassionate use; drug-resistant tuberculosis; early access; expanded access

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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  • Public Health Action (PHA), The Union's quarterly Open Access journal, welcomes the submission of articles on operational research. It publishes high-quality scientific research on health services, providing new knowledge on how to improve access, equity, quality and efficiency of health systems and services.

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