nandita sugandhi, m.d. clinton health access initiative july 22, 2014 melbourne, australia
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
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, 2014Melbourne, Australia
• 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
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..
IATT ART Formulary
4
• Minimum number of ARV formulations needed to provide all currently recommended preferred and alternative 1st and 2nd line WHO recommended regimens for all paediatric weight bands
Optimal
• Formulations that may be needed during transition and /or for special circumstancesLimited-use
• Everything else (not needed)Non-essential
IATT Paediatric ART Formulary
Evaluation Criteria
5
Criteria Description
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 prescribeEasy for caregivers to administerSupports adherence in children
Optimizes supply chain Easy to transportEasy to storeEasy to distribute
Available in resource limited settings
In country registrationReliable 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
IATT revised the Optimal Paediatric ARV Formulary in 2013.
6
Drug Class Drug Formulation Dose
NRTI AZT Oral liquid 50 mg/5mL
NNRTI EFV Tablet (scored) 200 mg
NNRTI NVP Tablet (disp, scored) 50 mg
NNRTI NVP Oral liquid 50 mg/5mL
PI LPV/r Tablet (heat stable) 100 mg/25mg
PI LPV/r Oral liquid 80 mg/20 mg/mL
FDC AZT/3TC Tablet (disp, scored) 60 mg/30 mg
FDC AZT/3TC/NVP Tablet (disp, scored) 60 mg/30 mg/50 mg
FDC ABC/3TC Tablet (disp, scored) 60 mg/30 mg
FDC ABC/AZT/3TC Tablet (non disp, scored) 60 mg/60 mg/30 mg
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
Drug Class Drug Formulation Dose
NRTI 3TC Tablet (disp) 30 mgNRTI TDF Oral powder 40 mg/scoop
NRTI TDF Tablet (unscored) 150 mgNRTI TDF Tablet (unscored) 200 mg
NNRTI ETV Tablet 25 mgNNRTI ETV Tablet 100 mg
PI DRV Tablet 75 mgPI RTV Oral liquid 400 mg/5mL
PI ATV Solid oral dosage form 100 mg
PI ATV Solid oral dosage form 150 mg
Int Inh RAL Chew tab (scored) 100 mgFDC d4T/3TC/NVP Tablet (disp, scored) 6 mg/30 mg/
50 mgFDC d4T/3TC Tablet (disp, scored) 6 mg/30 mg
8
UNICEF Procurement Trends – IATT 2013 Formulary
Uptake of Optimal Formulations
Use of Limited Use Formulations
Phase out of Non-essential Formulations
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
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
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
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
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
Registration
Product Selection
Quantification
Tendering and
Procurement
Communication
Phase in strategy
Monitoring
uptake
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!