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 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

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

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

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

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

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

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) MSF Access Campaign

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