Cherise 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, 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 TB

4

Goal & Major Outcome:

Increase access to optimal pediatric TB medicines which means correctly dosed, properly formulated, affordable, high quality products available

Requires multi-faceted approachSpeeding treatments to end pediatric TB

Market Understanding

Clinical and Regulatory

Understanding

Engaging Manufacturers

Policy and Uptake by Countries

Engaging Countries and

Donors

Information Exchange

Market Challenges

Janet Ginnard - UNITAID

SHA Meeting

28 October 2013

Paris, France

Page 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

Page 7

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 - ?

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

9

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.

MSF Access Campaign

Detjen, A. K et al. Public Health Action, Volume 2, Number 4, 21 December 2012 , pp. 126-132(7)

11

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