Rationalizing Pediatric ARV Formularies: The IATT Optimal Pediatric ARV List

1. Rationalizing Pediatric ARV Formularies: The IATT Optimal Pediatric ARV List Presented at IAS - July 2012 Dr. Nandita Sugandhi Clinical Advisor at the Clinton Health Access Initiative (CHAI)

2. Released April 23, 2012:

3. Questions you may be asking yourself • Who is the IATT? • Why do we need an “optimal pediatric list”? • How will this list help scale up treatment for children? • How was this list created? • What are the next steps?

4. Intra-agency Task Team on Prevention of HIV Infection in Pregnant Women, Mothers IATT and their Children (IATT) IATT Overview • Established in 1998 - included 5 UN agencies working in HIV and health: • (WHO, UNICEF, UNFPA, UNAIDS, World Bank) • 2003: membership expanded to include global partners in PMTCT and HIV care and treatment in children (23 agencies currently involved) • Provides a forum for: • Information sharing • Consensus building IATT Subcommittees Pediatric Working Group (PWG) Infant feeding Working Group + • Pediatric Working Group • Sub-committee of the main IATT • Focused on issues related to pediatric care and treatment issues • 2011 restructuring of IATT: consolidation of 2 working groups Developed Child Survival Working Group Optimal Pediatric Formulary List

5. IATT: Consensus amongst stakeholders Consensus amongst all stakeholders • Patients and Families • Clinicians • National Programs • Global Partners

6. May 2011: Creation of the 1st IATT Optimal Pediatric Formulary List Reasons for Development • WHO guidelines only recommend particular regimens but do not specify formulations of each drug to use • Proliferation of product choices and market fragmentation leading to instability in the pediatric marketplace • Normative guidance was needed on the best options to deliver all required 1st and 2nd line regimens for pediatric HIV patients • An optimal formulary can serve as guidance for national programs, procurement agencies, manufacturers

7. A dramatic scale-up of children on ART has been achieved with improved treatment options introduced over the past five years Yet pediatric ART coverage is less than half that of adult ART coverage +45% CAGR Source: WHO TUAPR 2011, published November 2011.

8. Current Number of Pediatric ARV formulations available: 43

9. Proliferation and Market fragmentation Uncoordinated transition to new products further spreads volumes Small volumes are further fragmented into sub-groups by age and weight bands The pediatric market is relatively small: ~456,000 on ART in 2010 Adult AZT Formulations AZT 300 mg AZT/3TC 300/150 mg AZT/3TC/NVP 300/150/200 mg Pediatric AZT Formulations AZT 50 mg/5 ml AZT 100 mg AZT/3TC 60/30 mg AZT/3TC 60/30 mg dispersible AZT/3TC/NVP 60/30/50 mg AZT 300 mg AZT/3TC 300/150 mg AZT/3TC/NVP 300/150/200 mg

10. Low individual country demand volumes and fragmentation continue to be problematic • Drug manufacturers are limited by minimum batch requirements • Manufacturers produce a minimum of generally several thousand packs of a particular product, called the “minimum batch requirement” • A product will not be produced until orders are meet the minimum batch requirement; otherwise, supplier risks incurring losses from carrying stocks which fall below country shelf-life requirements • Supply timelines can become highly unstable without ordering coordination Minimum batch size for LPV = 13.3k packs

11. What is fragmentation? What is rationalization?

12. Rationalization = Balancing the Need Individualized Treatment Public Health Approach

13. The Public Health Approach: WHO Essential Medicines List • Essential Medicines – satisfy the needs of the majority of the population and, therefore, should be available at all times, in adequate amounts, in appropriate dosage forms at a price the individual and community can afford. • EML list – used as a model list for developing countries to prioritize the selection and procurement of drugs that meet the needs of the population

14. Creation of the IATT Optimal Pediatric Formulary List: Selection Process Additional considerations include: • Historic global volumes • Manufacturing capacity • Characteristics of drug formulations (administration, transport, stability, cost)

15. Formulations, or products, reviewed

16. 15 formulations were identified by PWG IATT for inclusion on list of optimal paediatric ARV products that serve all recommended WHO regimens across all weight bands 15 optimal products serve all regimens and all weight-bands (including 2 syrups for PMTCT) Dispersible tablets of each drug , where available, were prioritized for inclusion LPV/r is the only pediatric treatment syrup on the optimal list outside of PMTCT use An additional 11 productswererecognized to be of limited-use

17. Challenges and Limitations • Not definitive • Not all-inclusive • Adult formulations not included • Only currently approved products listed • Needs to be updated regularly

18. Next steps: National-level adoption • Adaptation required at a national level to meet local needs that can then be used to guide procurement • Development of a standardized “toolkit” to assist programs to rationalize themselves • See Poster THPE704

19. Revision Process • Include new products and remove outdated ones • Adapt for new treatment recommendations • Consider the evolving epidemic and program needs

20. Why this matters… • Implementation of Treatment 2.0 for children • Enables sustainable access to paediatric ARV’s for continued scale-up • Creates a stable environment for further research and product development • Better outcomes for children living with HIV

21. Thanks! Poster #: THPE673 Poster #: THPE704