1. The Role of the IATT Optimal Paediatric ARV Formulary and Considerations for New Product Introduction Nandita Sugandhi, M.D. Clinton Health Access Initiative July 22, 2014 Melbourne, Australia

2. The Pediatric ARV Market is small and relatively complex Adoption of the IATT Optimal Formulary is a strategy for mitigating risks related to fragmentation Products phasing in/out may be included on the IATT Limited Use Formulary Considerations for transitioning to new optimal products Overview

3. Pediatric ARV market is small but complex. 93 adult patients All ages & weight bands One pill, once-a- day 7 paediatric patients Multiple formulations and regimens Multiple ages and weight bands Slide courtesy of IATT Child Survival Working Group..

4. IATT ART Formulary 4 Minimum number of ARV formulations needed to provide all currently recommended preferred and alternative 1 st and 2 nd line WHO recommended regimens for all paediatric weight bands Optimal Formulations that may be needed during transition and /or for special circumstances Limited-use Everything else (not needed) Non-essential IATT Paediatric ART Formulary

5. Evaluation Criteria 5 CriteriaDescription Meets WHO requirements Includes in the latest WHO guidelines for paediatric treatment Dosing flexibility Allows for the widest range of dosing options Approved by SRA/WHO PQ ≥ 1 quality assured product available User friendly Easy for HCWs to prescribe Easy for caregivers to administer Supports adherence in children Optimizes supply chain Easy to transport Easy to store Easy to distribute Available in resource limited settings In country registration Reliable supply Comparative cost Cost should NOT be the deciding factor in selection of a drug but comparative cost of similar drugs/drug formulations should be considered

6. IATT revised the Optimal Paediatric ARV Formulary in 2013. 6

7. Limited-use list: Transitioning Products and Special Circumstances 7 Transition – Phase in of TDF – Phase out of d4T (dual and triple FDC) Special circumstances – Third line – d4T

8. 8 UNICEF Procurement Trends – IATT 2013 Formulary Uptake of Optimal Formulations Use of Limited Use Formulations Phase out of Non-essential Formulations

9. The IATT list is a living document that will reviewed on a regular basis 9 Normative Guidance – WHO Guidelines Paediatric ARV Procurement Working Group (PAPWG) – Coordination of global procurement – Monitor trends in procurement and supply Country feedback – Consumption data End Users – HCW, caregiver and patient acceptability and preferences

10. Keeping Up With Change 10 Lists to be revisited at a minimum every 12 months with mandatory revisions every 2 years in line with WHO guideline schedule Specific ordering and utilization trends to be considered at next review – d4T phase out – ABC/AZT/3TC demand – Utilization of AZT syrup for PMTCT – DRV use – TDF demand – Adult formulations used in children Potential for new products to be included when available – LPV/r pellets – TDF/3TC/EFV – ABC/3TC/EFV – 4 in 1 granules

11. Country Introduction of New Formulations 11 Product Introduction SRA Approval Country Registration Product Selection Quantification Tendering and Procurement Communication and Training Phase in strategy Monitoring uptake

12. Country Introduction of New Formulations 12 Product Introduction SRA Approval Country Registration Product Selection Quantification Tendering and Procurement Communication and Training Phase in strategy Monitoring uptake IATT Optimal Formulary

13. Estimating Market Size and Implementation Issues 13 Estimating Market Size – Country Adoption Rapid v. Slow/Cautious Country Planning Cycles – Country guidelines v. Actual use – Quantification Additional or Replacement for existing formulations Changes in practice with introduction Target population Implementation – Phase in/Distribution – Communication Prescribers Caregivers – Monitoring and Evaluation Acceptability Actual Use Product Introduction SRA Approval Country Registrat ion Product Selection Quantific ation Tendering and Procurement Commun ication Phase in strategy Monitori ng uptake

14. Summary 14 Fragmentation leaves the Pediatric ARV market vulnerable to disruption Strategies such as adoption of the IATT Optimal Paediatric Formulary help mitigate some of these risks Several “optimal” ARV formulations are still needed and are in development Coordination by all stakeholders to ensure the market remains sustainable and meets the need for high quality pediatric ARV’s Careful consideration and planning is needed to ensure smooth introduction of new formulations. Thank you!