1. October 31, 2014 Satellite Symposium: The pediatric TB drug market: progress and future direction Market understanding: new data on the purchasing habits of 22 high-burden countries Cherise Scott Director, Pediatric Programs cherise.scott@tballiance.org

2. 2 Unmet Medical Need Not enough kids being treated – and not being treated appropriately Goal Increase access to correctly dosed, properly formulated, affordable, high quality pediatric TB medicines Implementing Partner Timeline High quality, child-friendly, properly dosed HRZ, HR and E products available by early 2016 Speeding Treatments to End Pediatric TB (STEP)-TB Overview

3. 3 Uptake Influenced Global treatment guidelines adopted National guidelines developed and health workers trained Child TB included in NSPs and Global Fund Concept Notes Funding committed for product and implementation Uptake Influenced Global treatment guidelines adopted National guidelines developed and health workers trained Child TB included in NSPs and Global Fund Concept Notes Funding committed for product and implementation Drugs Available Correct dosage & dispersible form for HRZ, HR, and E Shorten gap between approval of adult products vs. pediatric products Drugs Available Correct dosage & dispersible form for HRZ, HR, and E Shorten gap between approval of adult products vs. pediatric products Market Catalyzed Market Research--How many patients? Where? How are they currently being treated? Manufacturers’ commitments Momentum and visibility Market Catalyzed Market Research--How many patients? Where? How are they currently being treated? Manufacturers’ commitments Momentum and visibility Scope of Pediatric Initiative Three Key Outcomes Mid- 2013 Mid- 2016

4. 4 To understand countries readiness to adopt new child-friendly formulations To understand procurement processes and timelines in priority countries including key drivers and criteria for decision-making To obtain insight into the types and sources of funding used for pediatric treatments To identify potential barriers and bottlenecks to introduction and scale up of new formulations To gather data in order to inform targeted uptake planning activities and specific country strategies To landscape important stakeholders and partners in priority countries What we learn from the purchasing practices of countries? Purpose of Procurement Study

5. 5 Considered the largest supplier to national TB programs of quality pediatric TB drugs Possesses the most comprehensive data set on pediatric TB drug procurement Supplies products to countries through a direct procurement service and also offers grants to countries through donor funds 12 HBCs procure pediatric products from GDF as of 2014 Pediatrics products procured by grants and direct purchase using donor funds Initial Analysis

6. 6 Current Pediatric TB Market Understanding Source: 2014 WHO Global TB Report GDF Procurement Database

7. 7 Modeling the pediatric TB Burden in 22 HBCs Market Quantification Current Global Drug Facility (GDF) Clients

8. 8 Evidence that procured based on 2010 Rapid Advice Policy and Implementation of the 2010 Rapid Advice What we know HBCs supplied Peds Rx by the GDF AfghanistanBangladesh CambodiaKenya MyanmarNigeria Pakistan AfghanistanBangladesh CambodiaCongo (DR) KenyaMozambique MyanmarNigeria PakistanTanzania (UR) UgandaViet Nam

9. 9 What we know HBCs NOT supplied Peds Rx by the GDF Brazil Policy change and adoption to 2010 Rapid Advice; procure from PAHO China Policy unknown; NTP has shown interest; Adult products used for children Ethiopia Policy change and adoption of 2010 Rapid Advice; procurement unknown India Modified policy; some indication that changing to daily dosing; extent of use of pediatric FDCs unclear Indonesia Policy change and adoption of 2010 Rapid Advice; local procurement of pediatric FDCs (NOT PQ’d)

10. 10 What we know HBCs NOT supplied Peds Rx by the GDF Philippines Policy change and adoption of 2010 Rapid Advice; local procurement; adult products and syrups are used Russian FederationPolicy unknown; adult products used South Africa Policy change and adoption of 2010 Rapid Advice; local procurement Thailand Policy change and incomplete implementation of 2010 Rapid Advice; create on solutions using adult products from local manufacturers Zimbabwe Policy change and adoption of 2010 Rapid Advice; unknown procurement

11. 11 Underscores the need for strategy to access the markets outside of the GDF to create a viable market Feeds into larger efforts to understand all the aspects of the market especially in specific countries Procurement within the private sector needs to be further ascertained in these markets Country adoption of formulations can not be taken for granted Understanding where, when and what regarding country procurement of products to treat children shows where to target product launch/introduction efforts The timeline and location can be charted for introduction of the new pediatric formulations Using the data to inform product introduction and uptake Conclusions/Next Steps

12. Thank you! For more information on childhood TB go to: tballiance.org/children tballiance.org/children 12