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From availability to uptake: planning for the introduction of new, child-friendly anti-tuberculosis formulations
S Malhotra1, I Ursu2, R Ghoneim3
1Global Alliance for TB Drug Development, New York, New York, USA.
Insights
Introducing new child-friendly tuberculosis treatments requires assessing country readiness. Diverse processes and varying evidence needs complicate introduction, highlighting the need for tailored strategies to improve pediatric tuberculosis care.
Area of Science:
- Global Health
- Pharmaceutical Policy
- Pediatric Infectious Diseases
Background:
- Effective tuberculosis (TB) treatment for children is crucial for disease control.
- New child-friendly anti-TB formulations aim to improve treatment adherence and outcomes.
- Assessing country readiness is vital for timely access to pediatric TB treatments.
Purpose of the Study:
- To identify pathways and obstacles in introducing new pediatric anti-TB formulations.
- To understand country-specific factors influencing the adoption of improved TB treatments for children.
Main Methods:
- A comprehensive desk review of relevant policy documents was conducted.
- 146 stakeholder interviews were performed across 19 high-burden countries.
- Analysis focused on country readiness and adoption processes for pediatric TB treatments.
Main Results:
- World Health Organization (WHO) guidance often triggers adoption, but alignment and timelines vary.
- Adoption criteria differ: expert endorsement and local evidence in high-income countries; ease of administration and cost in low-income settings.
- Introduction involves an average of 10 steps, taking 18–71 months, with significant country-level variation.
Conclusions:
- Country-specific processes, adoption criteria, and evidence needs complicate new pediatric TB treatment introduction.
- Challenges in introducing new TB treatments for children vary significantly between low-income and high-income countries.
- Tailored strategies are essential to address unique hurdles and ensure a sustainable market for improved pediatric anti-TB drugs.
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.
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