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
• 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.
93 adult
patients
7 paediatric
patients
Slide courtesy of IATT Child Survival Working Group..
All ages & weight
bands
Multiple ages and
weight bands
One pill, once-aday
Multiple formulations
and regimens
IATT Paediatric ART Formulary
Optimal
Limited-use
Non-essential
• 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
ART Formulary
•IATT
Formulations
that may be needed during transition and
/or for special circumstances
• Everything else (not needed)
4
Evaluation Criteria
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 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
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formulations should be considered
IATT revised the Optimal Paediatric ARV Formulary in 2013.
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
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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
Drug Class
Drug
Formulation
Dose
NRTI
3TC
Tablet (disp)
30 mg
NRTI
TDF
Oral powder
40 mg/scoop
NRTI
TDF
Tablet (unscored)
150 mg
NRTI
TDF
Tablet (unscored)
200 mg
NNRTI
ETV
Tablet
25 mg
NNRTI
ETV
Tablet
100 mg
PI
DRV
Tablet
75 mg
PI
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 mg
FDC
d4T/3TC/NVP
Tablet (disp, scored)
6 mg/30 mg/
50 mg
FDC
d4T/3TC
Tablet (disp, scored)
6 mg/30 mg
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UNICEF Procurement Trends – IATT 2013 Formulary
Uptake of Optimal Formulations
Use of Limited Use Formulations
Phase out of Non-essential Formulations
8
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
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Keeping Up With Change
• 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
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Country Introduction of New Formulations
SRA Approval
Monitoring
uptake
Phase in
strategy
Country
Registration
Product
Introduction
Communication
and Training
Product
Selection
Quantification
Tendering
and
Procurement
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Country Introduction of New Formulations
SRA Approval
Monitoring
uptake
Phase in
strategy
Country
Registration
Product
Introduction
Communication
and Training
Product
Selection
IATT
Optimal
Formulary
Quantification
Tendering
and
Procurement
12
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
Monitori
ng
uptake
Phase in
strategy
SRA
Approval
Country
Registrat
ion
Product
Introduction
Commun
ication
Product
Selection
Quantific
ation
Tendering
and
Procurement
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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!
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