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: December 1, 2015
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