1. Pediatric TB Drugs Panel
Cherise Scott Janet Ginnard Rajneesh Taneja Grania Brigden

2. Overview of Pediatric Plan
Cherise Scott – TB Alliance
SHA Meeting
28 October 2013
Paris, France

3. Childhood TB
NO safe, appropriately-dosed formulations of first- line TB drugs for children
TB is one of the top 10 killers of children worldwide
In 2012, WHO reports an estimated 530,000 children acquired TB, and 74,000 children died (among HIV-negative children)
Due to diagnostic and reporting challenges, many children go untreated and unreported.
Children are susceptible to the most severe and fatal forms of the disease

4. Speeding treatments to end pediatric TB
Requires multi-faceted approach
Market Understanding
Clinical and Regulatory Understanding
Engaging Manufacturers
Policy and Uptake by Countries
Engaging Countries and Donors
Information Exchange
Goal & Major Outcome: Increase access to optimal pediatric TB medicines which means correctly dosed, properly formulated, affordable, high quality products available

5. Market Challenges Janet Ginnard - UNITAID SHA Meeting 28 October 2013
Paris, France

6. Market challenges in paediatric TB
Unknown scale of the problem
Already small market reduced further
Limited market incentives / high risk to participate in market
Poorly adapted products

7. Unknown scale of TB in children
Est. incident paediatric TB cases
~530,000 – 1,000,000
530K uses adult CDR
Diagnosed & notified
~349,000 (2012)
First reported in 2012
On treatment – 242K by GDF (2010)
Only 20-25% of children with TB?
Complete treatment - ?
No appropriately formulated, quality assured TB medicines in the right doses for children  individualized treatment approaches
Cured - ?
Sources: UNITAID TB medicines landscape 2013; WHO Global TB report 2013; Detjen et al. Public Health Action 2012

8. Manufacturing and Regulatory Challenges
Rajneesh Taneja – TB Alliance
SHA Meeting
28 October 2013
Paris, France

9. Key Manufacturing & Regulatory Challenges
Design and development of an age appropriate drug product
Stable
Dispersible in small quantities of water or food
Palatable
Economical
Regulatory approval challenges for the manufacturers
Manufacturer’s hesitation to incur initial expenditure for product development and stocking inventory

10. Policy and Uptake Challenges
Grania Brigden - Médecins Sans Frontières
SHA Meeting
28 October 2013
Paris, France

11. Policy and Uptake Challenges
For MSF
Country guidelines
If country has not adopted new guidelines then difficult to implement separate treatment guidelines
Lack of funding
Stock outs of TB drugs at peripheral health structures due to disruptions in funding
Lack of appropriate formulations
Difficulty in prescribing current formulations to match new dosage. Adding to pill burden, esp with HIV co-infection
For Others (results of survey)
34 countries responded 29 had childhood TB guidelines
19 incorporated the new 2010 guidance in national guideline
16 had started to implement the new dosages
To deliver correct dosages to children, 11 countries were using adult formulations, which were either broken or crushed, 11 were combining existing FDCs and loose products, while 2 countries were using only loose products.
Detjen, A. K et al. Public Health Action, Volume 2, Number 4, 21 December 2012 , pp (7)
MSF Access Campaign

12. The way ahead
Training at ALL levels to overcome the difficulties of the dosing regimens
WHO to give clear guidance for countries and manufacturers
Define market size and shape to encourage manufacturers to make new FDCs
Adequate Funding
Countries to prioritize children in TB programmes: Decentralization and integration.
MSF Access Campaign 12