From availability to uptake: planning for the introduction of new, child-friendly anti-tuberculosis formulations
METHODS: To understand pathways and potential obstacles to the introduction of new pediatric formulations, we performed a desk review of key policy documents and conducted 146 stakeholder interviews in 19 high-burden countries.
RESULTS: Issuance of World Health Organization (WHO) guidance serves as the trigger for considering adoption in most countries; however, the degree of alignment with WHO recommendations and duration of introduction processes vary. Endorsement by experts and availability of local evidence are leading criteria for adoption in upper-middle- and high-income countries. Ease of administration, decreased pill burden, and reduced treatment costs are prioritized in low- and lower-middle-income settings. Countries report an average of 10 steps on the path to new treatment introduction, with core steps taking between 18 and 71 months.
CONCLUSIONS: The process of new treatment introduction is complicated by diverse country processes, adoption criteria, and evidence requirements. Challenges differ between low- and middle-to-high-income countries. Responsiveness to the unique hurdles faced across settings is important in ensuring a sustainable market for improved pediatric anti-tuberculosis treatment.
Document Type: Research Article
Affiliations: 1: Global Alliance for TB Drug Development, New York, New York, USA 2: Mapping Health, London, UK 3: Management Sciences for Health, Arlington, Virginia
Publication date: 01 December 2015
The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.
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