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

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• 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

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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.

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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

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• 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

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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

The IATT list is a living document that will reviewed on a regular basis

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• 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

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• 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

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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

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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

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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

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• 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!