Understanding Market Size and Reporting Gaps for Paediatric TB in Indonesia, Nigeria and Pakistan: Supporting Improved Treatment of Childhood TB in the Advent of New Medicines

<div><p>Objective of the Study</p><p>We sought to understand gaps in reporting childhood TB cases among public and private sector health facilities (dubbed “non-NTP” facilities) outside the network of national TB control programmes, and the resulting impact of under-reporting on estimates of paediatric disease burden and market demand for new medicines.</p><p>Methodology</p><p>Exploratory assessments were carried out in Indonesia, Nigeria and Pakistan, reaching a range of facility types in two selected areas of each country. Record reviews and interviews of healthcare providers were carried out to assess numbers of unreported paediatric TB cases, diagnostic pathways followed and treatment regimens prescribed.</p><p>Main Findings</p><p>A total of 985 unreported diagnosed paediatric TB cases were identified over a three month period in 2013 in Indonesia from 64 facilities, 463 in Pakistan from 35 facilities and 24 in Nigeria from 20 facilities. These represent an absolute additional annualised yield to 2013 notifications reported to WHO of 15% for Indonesia, 2% for Nigeria and 7% for Pakistan. Only 12% of all facilities provided age and sex-disaggregated data. Findings highlight the challenges of confirming childhood TB. Diagnosis patterns in Nigeria highlight a very low suspicion for childhood TB. Providers note the need for paediatric medicines aligned to WHO recommendations.</p><p>Conclusion: How Market Data Can Support Better Public Health Interventions</p><p>This study emphasises the impact of incomplete reporting on the estimation of disease burden and potential market size of paediatric TB medicines. Further studies on “hubs” (facilities treating large numbers of childhood TB cases) will improve our understanding of the epidemic, support introduction efforts for new treatments and better measure markets for new paediatric medicines.</p></div

Numbers of Paediatric Patients Estimated Per Facility Type and Numbers of Estimated New Paediatric TB Cases.

<p>Numbers of Paediatric Patients Estimated Per Facility Type and Numbers of Estimated New Paediatric TB Cases.</p

Summary of Sites Visited, by Country and Facility Type.

<p>Summary of Sites Visited, by Country and Facility Type.</p

Diagnostic Tests requested by healthcare practitioners when faced with a suspect case of paediatric TB (several tests may be requested for one child).

<p>Diagnostic Tests requested by healthcare practitioners when faced with a suspect case of paediatric TB (several tests may be requested for one child).</p

Overview of findings: number of children seen in non-NTP facilities, diagnosed with suspect or confirmed tuberculosis, but not reported to NTP (by country, (May–July 2013).

<p>Overview of findings: number of children seen in non-NTP facilities, diagnosed with suspect or confirmed tuberculosis, but not reported to NTP (by country, (May–July 2013).</p

Geographic distribution of patients.

<p>Locations of patients included in the individual patient data meta-analysis. The number indicates the number of participants included from each location.</p

Summary of treatment outcomes for children treated for MDR-TB.

<p>Summary of treatment outcomes for children treated for MDR-TB.</p

Tuberculosis case definitions and treatment outcome definitions.

<p>Tuberculosis case definitions and treatment outcome definitions.</p

Clinical variables associated with treatment outcome in children with MDR-TB: <i>N</i> = 975.

<p>Clinical variables associated with treatment outcome in children with MDR-TB: <i>N</i> = 975.</p

Proportion of patients achieving successful treatment outcomes, stratified by method of diagnosis, by site.

<p>Excludes lost to follow-up and cases that did not have an outcome. Results estimated via random effects modeling to account for clustering by cohort. The 95% confidence limits were estimated using exact (Clopper-Pearson) method. *Unpublished data.</p