From Availability to Uptake: Planning for the Introduction of New, Child-Friendly Anti-Tuberculosis Formulations

Journal Article
  • S. Malhotra
  • I. Ursu
  • R. Ghoneim
  • P. Paredes Jodrey
  • M. Soucy Brown
  • M. Barr-DiChiara
International Journal of Tuberculosis and Lung Disease
Dec. 1, 2015, Vol. 19 (Suppl. 1): S32-S38(7).

Abstract

BACKGROUND:

Assessing the state of country readiness for the introduction of newchild-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.

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