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Pediatric TB
Drugs Panel
Cherise Scott
Janet Ginnard
Rajneesh Taneja
Grania Brigden
Overview of Pediatric Plan
Cherise Scott – TB Alliance
SHA Meeting
28 October 2013
Paris, France
Childhood TB
• NO safe, appropriately-dosed formulations of firstline 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
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Speeding treatments to end pediatric TB
Requires multi-faceted approach
Engaging
Manufacturers
Goal & Major Outcome:
Increase access to optimal
pediatric TB medicines which
means correctly dosed,
properly formulated,
affordable, high quality
products available
Market
Understanding
Clinical and
Regulatory
Understanding
Policy and
Uptake by
Countries
Engaging
Countries and
Donors
Information
Exchange
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Market Challenges
Janet Ginnard - UNITAID
SHA Meeting
28 October 2013
Paris, France
Market challenges in paediatric TB
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Poorly
adapted
products
Unknown
scale of the
problem
Limited
market
incentives /
high risk to
participate in
market
Already small
market
reduced
further
Unknown scale of TB in children
Est. incident paediatric TB cases
~530,000 – 1,000,000
Diagnosed & notified
~349,000 (2012)
On treatment – 242K
by GDF (2010)
Complete
treatment - ?
Cured - ?
530K uses
adult CDR
First reported in
2012
Only 20-25% of
children with TB?
No appropriately formulated,
quality assured TB medicines
in the right doses for children
 individualized treatment
approaches
Sources: UNITAID TB medicines landscape 2013; WHO Global TB report 2013; Detjen et al. Public Health Action 2012
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Manufacturing and Regulatory
Challenges
Rajneesh Taneja – TB Alliance
SHA Meeting
28 October 2013
Paris, France
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
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Policy and Uptake Challenges
Grania Brigden - Médecins Sans Frontières
SHA Meeting
28 October 2013
Paris, France
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. 126-132(7)
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MSF Access Campaign
The way ahead
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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