title: From availability to uptake: planning for the introduction of new, child-friendly anti-tuberculosis formulations.
abstract: BACKGROUND
  Assessing the state of country readiness for the introduction of new, child-friendly anti-tuberculosis formulations can highlight potential bottlenecks, facilitate early planning, and accelerate access to appropriate treatment for children with tuberculosis (TB).
  
  
  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.
authors.affiliation: Global Alliance for TB Drug Development, New York, New York, USA.
authors.forename: S
authors.initials: S
authors.lastname: Malhotra
authors.affiliation: Mapping Health, London, UK.
authors.forename: I
authors.initials: I
authors.lastname: Ursu
authors.affiliation: Management Sciences for Health, Arlington, Virginia.
authors.forename: R
authors.initials: R
authors.lastname: Ghoneim
authors.affiliation: Management Sciences for Health, Arlington, Virginia.
authors.forename: P Paredes
authors.initials: PP
authors.lastname: Jodrey
authors.affiliation: Management Sciences for Health, Arlington, Virginia.
authors.forename: M Soucy
authors.initials: MS
authors.lastname: Brown
authors.affiliation: Mapping Health, London, UK.
authors.forename: M
authors.initials: M
authors.lastname: Barr-DiChiara
mesh_terms: D000995:Antitubercular Agents / Q000008:administration & dosage / Q000191:economics*; D002626:Chemistry, Pharmaceutical / Q000191:economics*; D002648:Child; D017048:Health Care Costs; D006801:Humans; D017410:Practice Guidelines as Topic; D014376:Tuberculosis / Q000188:drug therapy* / Q000191:economics*; D014944:World Health Organization
chemical_list: D000995:Antitubercular Agents