ArticlePublic health action2019
Barriers and facilitators to early access of bedaquiline and delamanid for MDR-TB: a mixed-methods study.
Article in Public health action, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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Who cites it
6 citing papers in PubMed.
- Article
- Treatment outcomes of extensively drug-resistant tuberculosis in Europe: a retrospective cohort study.The Lancet regional health. Europe · 2025Article
- Country-level heterogeneity in MDR-TB drug susceptibility supports country-specific policy development.Frontiers in tuberculosis · 2025Article
- Access to Innovative Medicines: Regulation Change and Factors Associated with Drug Approval Lag in Malaysia.Therapeutic innovation & regulatory science · 2024Article
- Addressing the needs of people with extensively drug-resistant TB through pre-approval access to drugs and research.Public health action · 2023Article
- Bedaquiline resistance probability to guide treatment decision making for rifampicin-resistant tuberculosis: insights from a qualitative study.BMC infectious diseases · 2022Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
settingPhase 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.
objectiveTo 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.
designWe 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.
resultsWe 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.
conclusionManufacturers 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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