Agenda
• Introduction- Jessica Rodrigues, IATT
• Paediatric Treatment Optimization- George Silberry, Senior
Technical Advisor for Pediatric HIV, OGAC
• Optimal regimen selection and sequencing- Elaine Abrams
Senior Director for Research, ICAP
• Optimal formulation selection- Marc Lallemant Head of
Pediatric HIV, DNDi and Janice Lee Project Manager for
Pediatric HIV, DNDi
• Optimizing supply chain management- Nandita Sugandhi,
Senior Clinical Advisor, CHAI and Marianne Gauval
Associate Director of Pediatric Access, CHAI
• Q&A/Discussion- Surbhi Modi, Maternal and Infant HIV
Team Lead, CDC
<7% patients on ART are children
93 adult patients
7 pediatric patients
All ages & weight bands
Multiple weight bands
One pill, once-a-day
Multiple formulations
2
Wide variety of Paeds ARV formulations 65+ Products and counting!
DDI
FTC
Tablet (disp,scored) as
sulfate
Tablet (scored) as sulfate
Oral liquid as sulfate
Tablet (dispersible, scored)
Oral liquid
Tablet (scored)
Capsule
Tablet
Oral liquid
Tablet (dispersible)
Tablets
Capsule
Capsule
Powder for Oral solution
Cap, unbuffered, enteric
coated
Cap, unbuffered, enteric
coated
Tab (buffered, chewable,
disp)
Tablet (buffered, chewable,
dispersible)
Tablet (buffered, chewable,
dispersible)
powder for Oral liquid
(Buffered)
Oral liquid
TDF
TDF
TDF
Oral powder
Tablet (unscored)
Tablet (unscored)
ABC
ABC
ABC
AZT
AZT
AZT
AZT
AZT
3TC
3TC
3TC
D4T
D4T
D4T
DDI
DDI
DDI
DDI
DDI
PI cont’d
NNRTI
NRTI
Tablet (scored)
Tablet
Tablet (unscored)
Tablet (disp)
Capsules
Capsules
Capsules
Oral liquid
Tablet (dispersible,
NVP scored)
200mg
50mg
200 mg
100mg
50 mg
100 mg
200 mg
150mg/5ml
TPV
FPV
50mg
NVP Tablet (non dispersible)
50mg
NVP Tablet (non dispersible)
NVP Oral liquid
100mg
50mg/5ml
NVP Tablet (dispersible)
100 mg
125 mg
NVP Tablet (nondispersible)
ETV Tablet
20mg
25mg
200 mg
ETV Tablet
100mg
60 mg
60 mg
100mg/5ml
60 mg
50mg/5ml
60mg
100 mg
100 mg
50mg/5ml
30mg
30mg
15mg
20mg
5mg/5ml
EFV
EFV
EFV
EFV
EFV
EFV
EFV
EFV
PI
25mg
50 mg
100 mg
2g, 4g
bottle
10 mg/ml
40mg/scoo
p
150 mg
200mg
LPV/r
LPV/r
LPV/r
RTV
DRV
DRV
DRV
ATV
ATV
ATV
ATV
Tablet (hs)
Oral liquid
Oral pellets
Oral liquid
Tablets
Tablets
Oral liquid
caps as sulfate
caps as sulfate
Powder
caps as sulfate
Oral liquid
Oral liquid
Integrase Inhibitors
RAL
chewable Tabs (scored)
100 mg
RAL
chewable Tabs
25 mg
RAL
Packets for oral susp
100mg
FDC’s
AZT/3TC
AZT/3TC
AZT/3TC/NVP
D4T/3TC/NVP
100mg/25mg
80/ 20 mg/ml
40mg/10mg
400mg/5ml
75 mg
150 mg
500mg/5ml
100 mg
150 mg
50mg
200 mg
500mg/5mL
250mg/5mL
D4T/3TC/NVP
D4T/3TC
D4T/3TC
ABC/3TC
ABC/3TC
ABC/3TC
ABC/3TC/AZT
Tablet (disp
scored)
Tablet (scored)
Tablet (disp
scored)
Tablet (disp
scored)
Tablet (disp,
scored)
Tablet (disp,
scored)
Tablet
(dispersible,
scored)
Tablet(disp,
scored)
Tablet (disp,
scored)
Tablet (scored)
Tablet (non disp,
scored)
60/30 mg
60/30 mg
60/30/50 mg
6/30/50 mg
12/60/100
mg
6/30 mg
12/30 mg
60/30 mg
120/60 mg
60/30 mg
3
60/30/60mg
Low volumes and fragmentation are
problematic
Suppliers are limited by minimum batch requirements
►Manufacturers produce a minimum of generally several thousand packs of a particular
product, called the “minimum batch requirement”
► A product will not be produced until orders are meet the minimum batch requirement;
otherwise, supplier risks incurring losses from carrying stocks which fall below country shelflife requirements
► Supply timelines can become highly unstable without ordering coordination
Minimum batch size
Optimize treatment with existing products
Drug Class
Drug
Formulation
Dose
NNRTI
NNRTI
EFV
NVP
Tablet (scored)
Tablet (disp, scored)
200 mg
50 mg
NNRTI
NVP
Oral liquid
50 mg/5mL, 100ml
PI
LPV/r
Tablet (heat stable)
100 mg/25mg
PI
FDC
LPV/r
AZT/3TC
Oral liquid
Tablet (disp, scored)
80 mg/20 mg/mL
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,
120mg/60mg
Criteria'
Descrip, on'
WHO'recommended''
Safety'and'efficacy'established'
Available'in'resource'limited'
se9 ngs'
In'country'registra6on'
SRA/WHO'PQ'approved'
≥'1'quality'assured'product'available'
User'friendly'
Easy'for'HCW’s'to'prescribe'
Easy'for'caregivers'to'administer'
Supports'adherence'in'children'
Op, mizes'supply'chain'
x
Easy'to'transport'
Easy'to'store'
Easy'to'distribute'
Dosing'flei bility'
Allows'for'the'widest'range'of'dosing'op6ons'
Compara, ve'cost'
Cost'should'NOT'be'the'deciding'factor'in'selec6on'
of'a'drug'but'compara6ve'cost'of'similar'drugs/
drug'formula6ons'should'be'considered'
Reliable'supply'
2015 Optimal IATT formulary
2015 IATT Limited-use list
Stay tuned….
•
•
•
The IATT Paediatric Optimal Formulary and
Limited use lists are designed to evolve over
time as treatment recommendations,
programme trends and available dosage
forms change.
The next revision is scheduled for 2016 Q1
Issues to be addressed
– Placement of newer dosage forms (e.g.. LPV/r oral
pellets)
– New dosing recommendations from WHO
•
•
•
2011
2013
Drug%
Class%
Drug%
Formula- on%
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%
15 Products
Tablet%(heat%
stable)%
100%mg/25mg%
PI%
LPV/r%
Oral%liquid%
80%mg/20%mg/mL%
FDC%
AZT/3TC%
LPV/r%
Tablet%(disp,%
scored)%
60%mg/30%mg%
2014
Drug%
Class%
Drug%
Formula- on%
Dose%
NNRTI%
EFV%
Tablet%(scored)%
200%mg%
NVP%
FDC%
AZT/
3TC/NVP%
Tablet%(disp,%
scored)%
60%mg/30%mg/50%
mg%
NNRTI%
Tablet%(disp,%scored)%
50%mg%
FDC%
ABC/3TC%
Tablet%(disp,%
scored)%
60%mg/30%mg%
NNRTI%
NVP%
Oral%liquid%
50%mg/5mL,%100ml%
PI%
LPV/r%
Tablet%(heat%stable)%
100%mg/25mg%
FDC%
ABC/
Tablet%(non%disp,% 60%mg/60%mg/30%
AZT/3TC%
scored)%
mg%
10 Products
LPV/r%
Oral%liquid%
FDC%
AZT/3TC%
Tablet%(disp,%scored)%
60%mg/30%mg%
FDC%
PI%
AZT/3TC/
NVP%
Tablet%(disp,%scored)%
60%mg/30%mg/50%mg%
FDC%
ABC/3TC%
Tablet%(disp,%scored)%
9 Products
Drug%
Formula+on%
Dose%
2013
2014
Drug%
Class%
First line
Second line
Third line
•
Feedback from country programmes is
essential to maintain the optimal formulary
Global level support for pediatric ARV
procurement is available
60%mg/30%mg,%120mg/
60mg%
2011
Drug%
Formula+on%
Dose%
– Procurement trends
– Supply concerns
•
80%mg/20%mg/mL%
11 Products
13 Products
10
Products
Ra+onale%
for%
use%
Paediatric ARV Procurement Working Group (PAPWG)
Supporting sustained supply through the coordinated procurement of paediatric ARVs
Objective: Reducing the risks of supply disruption to paediatric ARVs (improving the supply
security) by ensuring sustained supply through a coordinated procurement mechanism
 Strategically manage demand
 Reduce fragmentation through streamlined product selection
 Advocate for and transition countries to use the IATT formulary list of optimal and
limited-use products emphasizing the use of the 2013 WHO Consolidated Guidelines
 Support the transition to new HIV/AIDS treatment formulations and regimens
(WHO/IATT/UNICEF) Policy Briefs
 Recommendations to address phase-out of d4T and ddI procurement challenges in the
paediatric ARV market
 Supply planning for new dosage form of lopinavir and ritonavir oral pellets

Raise awareness with stakeholders on general and specific challenges in the paediatric
ARV marketplace
 Regular communication through the Paediatric ARV Procurement Working Group Update, a biannual publication available in English, Spanish, and French
More information on the PAPWG is available @
http://www.theglobalfund.org/en/sourcingprocurement/updates/2014-0813_Update_on_Paediatric_ARV_Procurement_Working_Group/
PAPWG and Procurement Consortium Membership
Working Group Members
 Clinton Health Access Initiative (CHAI)
 Ethiopia Pharmaceuticals Fund and
Supply Agency (PFSA)
 Global Fund to Fight AIDS, TB and
Malaria
 Kenya Medical Supply Authority
(KEMSA)
 Organization of Eastern Caribbean
States (OECS)
 Pan-American Health Organization
(PAHO)
 Partnership for Supply Chain
Management (PfSCM)
 President's Emergency Plan for AIDS
Relief (PEPFAR)
 United Nations Children’s Fund
(UNICEF)
 UNITAID
Working Group Observers
 Drugs for Neglected Diseases Initiative (DNDi)
 Elizabeth Glaser Pediatric AIDS Foundation (EGPAF)
 International AIDS Society (IAS)
 Médecins Sans Frontières (MSF)
 World Health Organization (WHO)
Procurement Consortium
 CHAI
 Global Fund, Pooled Procurement Mechanism
(PPM)
 KEMSA
 MSF
 OECS
 PAHO
 PFSA
 USAID, Supply Chain Management System (SCMS)
 UNICEF
Reference: Paediatric ARV Procurement Working Group Update _ 5 October 2015
PROCUREMENT CONSORTIUM FORECAST (2015):
IATT Formulary Profile
2015 Planned Procurements
Limited-Use
0%
Optimal / PMTCT
8%
Unreviewed
0%
Non-Essential
7%
Optimal
85%
The IATT stance for paediatric formulations (Optimal, Limited-Use and Non-Essential) reflects the 2013 Updated Paediatric ARV Formulary List
from The Interagency Task Team on the Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and Children.
Courtesy of Wesley Kreft, WHO/AMDS Meeting with Pharmaceutical Companies and Stakeholders / Geneva, Switzerland / 20 March 2015
Quarterly Order Cycle Coordination
Procurement Consortium places orders for paediatric ARVs for the respective country
recipients and partners they support
•
•
•
Quarterly coordinated procurement benefits manufacturers to better plan for impending orders
and production, thereby, minimizing the uncertainty of the timing of market demand. Through
this process, better planning can take place by suppliers for longer manufacturing runs and
minimum batch sizes.
The PAPWG expects that through scheduled coordinated procurement, a majority of paediatric
ARV orders will be placed four times a year on pre-determined dates that are made available to
both procurers and suppliers.
Countries and procurement entities may therein reduce fragmented demand for commodities by
adhering to order cycles and deadlines.
Regardless of the funding source, ordering on a synchronized, quarterly schedule is critical to the reliable supply of paediatric ARVs for
all countries. Furthermore, those procuring paediatric ARVs are likely to be able to leverage better lead-times by placing their orders
with manufacturers on these dates.
Reference: Paediatric ARV Procurement Working Group Update _ 5 October 2015
Road Ahead: Improved Engagement
 Active engagement with countries and partners to adopt/transition to the
prescribed IATT formulary to guide selection and procurement of paediatric ARVs
around a subset of optimal products
 Periodic review of forecasts to communicate to Manufacturers/Suppliers
anticipated orders by the Procurement Consortium members
 Ongoing monitoring of market challenges and development of solutions as a group
(e.g., registration/WHO PQ/FDA approvals, sub-batch orders, lead-times)
 Implement reporting point indicators to track and validate progress made by the
group
 Work with countries not part of the procurement consortium to join or at a
minimum adopt coordination practices
 Continue to engage with suppliers individually and collectively as the PAPWG
Courtesy of Wesley Kreft, WHO/AMDS Meeting with Pharmaceutical Companies and Stakeholders / Geneva, Switzerland / 20 March 2015
Q&A/Discussion