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

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slide1

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

slide2

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
pediatric arv market is small but complex
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..

slide7

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
slide8

UNICEF Procurement Trends – IATT 2013 Formulary

Uptake of Optimal Formulations

Use of Limited Use Formulations

Phase out of Non-essential Formulations

slide9

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
slide10

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
slide13

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
slide14

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!