1 / 14

Nandita Sugandhi, M.D. Clinton Health Access Initiative July 22, 2014 Melbourne, Australia

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. Overview. The Pediatric ARV Market is small and relatively complex

chadwick-morse
Download Presentation

Nandita Sugandhi, M.D. Clinton Health Access Initiative July 22, 2014 Melbourne, Australia

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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. Overview • 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

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

  4. IATT Paediatric ART Formulary IATT ART Formulary

  5. Evaluation Criteria

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

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

  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 • 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 • Lists to be revisited at a minimumevery 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

  12. Country Introduction of New Formulations IATT Optimal Formulary

  13. Estimating Market Size and Implementation Issues 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

  14. Summary • 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!

More Related