Scott Janet Ginnard Rajneesh Taneja Grania Brigden Pediatric TB Drugs Panel Overview of Pediatric Plan Cherise Scott TB Alliance SHA Meeting 28 October 2013 Paris France 3 NO safe appropriatelydosed formulations of firstline TB drugs for ID: 475478
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Slide1
Cherise Scott Janet GinnardRajneesh TanejaGrania Brigden
Pediatric TB Drugs PanelSlide2
Overview of Pediatric Plan
Cherise Scott – TB Alliance
SHA Meeting
28 October 2013
Paris, FranceSlide3
3
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
Childhood TBSlide4
4Goal & Major Outcome:Increase access to optimal pediatric TB medicines
which means
c
orrectly dosed, properly formulated, affordable, high quality products available
Requires multi-faceted approach
Speeding treatments to end pediatric TB
Market Understanding
Clinical and Regulatory Understanding
Engaging Manufacturers
Policy and Uptake by Countries
Engaging Countries and Donors
Information
ExchangeSlide5
Market Challenges
Janet
Ginnard
- UNITAID
SHA Meeting
28 October 2013
Paris, FranceSlide6
Market challenges in paediatric TBSlide7
First reported in 2012
Only 20-25% of children with TB?
530K uses adult CDR
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
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 - ?Slide8
Manufacturing and Regulatory Challenges
Rajneesh Taneja – TB Alliance
SHA Meeting
28 October 2013
Paris, FranceSlide9
Key Manufacturing & Regulatory ChallengesDesign and development of an age appropriate drug productStableDispersible 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
9Slide10
Policy and Uptake Challenges
Grania
Brigden
-
Médecins
Sans
Frontières
SHA Meeting
28 October 2013
Paris, FranceSlide11
Policy and Uptake ChallengesFor MSFCountry 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.
MSF Access Campaign
Detjen, A. K et al.
Public Health Action
, Volume 2, Number 4, 21 December 2012 , pp. 126-132(7)
11Slide12
The way aheadTraining at ALL levels to overcome the difficulties of the dosing regimensWHO 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