paediatric arv procurement working group … · country ethiopia included in papwg forecast nigeria...

PAEDIATRIC ARV PROCUREMENT WORKING GROUP Consolidated Pediatric ARV Forecast of the Procurement Consortium

WHO/AMDS Meeting with Pharmaceutical Companies and Stakeholders Geneva, Switzerland 20 March 2015

PAEDIATRIC ARV PROCUREMENT WORKING GROUP MEMBERSHIP

Working Group Members • Clinton Health Access Initiative • Global Fund to Fight AIDS, TB and

Malaria • Organization of Eastern Caribbean States • Partnership for Supply Chain

Management • Supply Chain Management Systems • UNICEF • UNITAID • PAHO • KEMSA • PFSA

Working Group Observers • Drugs for Neglected Diseases initiative • International AIDS Society • Early Infant Diagnostics Working Group • Médecins Sans Frontières • World Health Organization

Procurement Consortium

• Global Fund Pooled Procurement Mechanism (PPM)

• UNICEF

• SCMS

• CHAI

• OECS (observer)

• MSF (observer)

• PAHO

• KEMSA

• PFSA

PAEDIATRIC ARV PROCUREMENT AND SUPPLY SECURITY RISKS

Market Landscape

Unattractive market: large number of countries with small orders and small tenders

Large range of products; demand for some less than batch size, further fragmented by the use and procurement of duplicative and suboptimal formulations (e.g., syrups, non-dispersible ARVs)

Lack of sufficient visibility, volumes, and/or capacities to individually coordinate sufficient orders and to aggregate demand

Poor supply security with long and variable lead-times

Objective: Reducing the risks of supply disruption to paediatric ARVs (improving the supply security)

Ensure sustained supply through 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

2013 IATT OPTIMAL PAEDIATRIC ARV FORMULARY

4

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

* Oral liquid to be used to provide infant prophylaxis for PMTCT

*Based on 2011 IATT List

Formulation 2013

TOTAL 9,023,695

Optimal* 7,686,211

AZT/3TC/NVP (60/30/50 mg) Tablet (Disp) - 60 4,480,902

NVP (50/5 mg/ml) Syrup - 100 757,750

ABC/3TC (60/30 mg) Tablet (Disp) - 60 353,178

NVP (50 mg) Tablet (Disp) - 30 300,880

EFV (200 mg) Tablet (Scored) - 90 300,868

AZT/3TC (60/30 mg) Tablet (Disp) - 60 295,865

LPV/r (100/25 mg) Tablet (HS) - 60 240,396

AZT (50/5 mg/ml) Syrup - 240 214,419

d4T/3TC/NVP (6/30/50 mg) Tablet (Disp) - 60 213,290

NVP (50/5 mg/ml) Syrup - 240 206,285

NVP (50/5 mg/ml) Syrup - 25 119,727

d4T/3TC (6/30 mg) Tablet (Disp) - 60 66,892

LPV/r (80/20 mg/ml) Syrup - 300 40,684

AZT (50/5 mg/ml) Syrup - 100 33,338

ABC (60 mg) Tablet (Disp) - 60 30,610

ddI (25 mg) Tablet (disp) - 60 12,506

LPV/r (80/20 mg/ml) Syrup - 160 9,823


ddI (200 mg) Capsule (EC) - 30 3,596

ddI (125 mg) Capsule (EC) - 30 1,302

*Based on 2013 IATT List

Formulation 2014

TOTAL 10,598,289

Optimal* 9,447,987

AZT/3TC/NVP (60/30/50 mg) Tablet (Disp) - 60 4,321,816

NVP (50/5 mg/ml) Syrup - 100 1,820,485

AZT/3TC (60/30 mg) Tablet (Disp) - 60 797,337

ABC/3TC (60/30 mg) Tablet (Disp) - 60 763,412

NVP (50/5 mg/ml) Syrup - 25 389,328

EFV (200 mg) Tablet (Scored) - 90 388,926

LPV/r (100/25 mg) Tablet (HS) - 60 253,780

NVP (50/5 mg/ml) Syrup - 240 246,122


AZT (50/5 mg/ml) Syrup - 240 133,936

LPV/r (80/20 mg/ml) Syrup - 300 49,881


LPV/r (80/20 mg/ml) Syrup - 160 18,676

AZT (50/5 mg/ml) Syrup - 100 12,021

AZT (50/5 mg/ml) Syrup - 200 2,886

d4T/3TC (6/30 mg) Tablet (Disp) - 60 13,887

d4T/3TC/NVP (6/30/50 mg) Tablet (Disp) - 60 2,000

ddI (25 mg) Tablet (disp) - 60 4,935

ddI (200 mg) Capsule (EC) - 30 2,200

d4T/3TC/NVP (12/60/100 mg) Tablet (Disp) - 60 207

2013 – 2014 PROCUREMENT VOLUMES OF THE PROCUREMENT CONSORTIUM

Methodology and Assumptions This Anticipated Demand Forecast represents the 2015 preliminary planned procurement orders for paediatric ARVs procured through the PAPWG Procurement Consortium. Countries receiving GFATM funding but procuring through their own procurement systems have not been included. Source Data: •GF PSM: Preliminary aggregated order data from the Global

Fund PSM (Procurement and Supply Management) Plans for orders procured through PPM, UNICEF and Country Governments. • SCMS: Aggregated data from SCMS procurement database for

orders placed in 2015

2015 - 2016 FORECAST OF THE PROCUREMENT CONSORTIUM

Country Included in PAPWG forecast

Number of Children on ARVs*

ART Coverage*

Pediatric ARV Procurement Sources ⱡ

Afghanistan Yes 16 32% GFATM-UNICEF

Algeria No 437 40%

Angola No 4,167 14%

Argentina No 3,337 0%

Armenia Yes - - GFATM-PPM

Azerbaijan No 36 21%

Bangladesh No 60 21%

Belarus No - -

Belize No 98 47%

Benin No 1,374 16%

Bhutan No - -

Bolivia No 104 10%

Botswana No 9,553 84%

Brazil No 6,150 0%

Burkina Faso No 1,869 10%

Burundi Yes 2,189 12% USAID-SCMS

Cambodia No 4,052 78%

Cameroon No 5,631 6%

Cape Verde No 63 48%

Central African Republic No 922 5%

Chad No 1,573 5%

Chile No - -

China** No 2,322 -

Columbia No - -

Comoros Yes - - GFATM-PPM

Congo No 1,170 9%

Costa Rica No - -

Cote d'Ivoire Yes 5,467 8% GFATM-PPM, USAID-SCMS

Cuba No - -

D R Congo No 5,055 8%

Djibouti No 46 4%

Dominican Republic No - -

Ecuador No 580 70%

Egypt No 53 22%

El Salvador Yes 308 35% GFATM-UNICEF

Eritrea No 692 21%

Ethiopia No 18,931 9%

Fiji No - -

Gabon No 732 18%

Gambia No 289 18%

Georgia Yes 45 74% GFATM-PPM

Ghana No 3,907 11%

Guatemala No 945 31%

Guinea No 1,333 10%

Guinea-Bissau No 428 7%

Guyana Yes - - GFATM-PPM

Haiti Yes 2,625 20% GFATM-UNICEF, USAID-SCMS

Honduras Yes 725 33% GFATM-PPM

India No 41,638 30%

Indonesia Yes 1,631 0% GFATM-PPM

Iran No 172 8%

Jamaica No 515 93%

Kenya Yes 60,141 31% GFATM-KEMSA

Kyrgyzstan Yes 295 95% GFATM-UNICEF

Lao No 183 35%

Lebanon No 4 0%

Lesotho No 5,243 15%

Liberia No 378 7%

Madagascar No 17 0%

Malawi Yes 42,220 24% GFATM-PPM

Malaysia No 507 68%

Maldives No - -

Mali Yes 2,001 13%

Mauritania Yes - - GFATM-PPM

Mauritius No - -

Mexico No 1,802 80%

Morocco Yes 333 53% GFATM-PPM

Mozambique Yes 41,400 22% GFATM-PPM, USAID-SCMS

Multicountry Americas (CARICOM / PANCAP) *** No - -

Multicountry Western Pacific No - -

Myanmar Yes 4,925 43% GFATM-UNICEF

Namibia No 10,247 45%

Nepal Yes 638 34% GFATM-PPM

Nicaragua No 112 75%

Niger Yes 554 7% GFATM-PPM

Nigeria Yes 47,313 12% GFATM-PPM, USAID-SCMS

Pakistan No 70 4%

Palestine No - -

Panama No 226 84%

Papua New Guinea No 876 20%

Paraguay No 219 78%

Peru No 901 37%

Philippines Yes - - GFATM-PPM

Rep. of Moldova No 82 69%

Rwanda Yes - - USAID-SCMS

S.Tome&Principe No 11 3%

Senegal No 823 15%

Sierra Leone No 385 8%

Somalia No 315 6%

South Africa No 156,706 44%

South Sudan No 286 2%

Sri Lanka Yes - - GFATM-PPM

Sudan No 250 5%

Suriname No - -

Swaziland No 7,898 46%

Tajikistan Yes 254 26%

Tanzania Yes 38,848 16% GFATM-PPM

Thailand No 5,142 62%

East Timor Yes - - GFATM-PPM

Togo No 3,258 16%

Tunisia No - -

Uganda Yes 43,525 22% GFATM-PPM, USAID-SCMS

Ukraine No - -

Uruguay No - -

Uzbekistan No 3,145 95%

Venezuela No 976 32%

Vietnam No 4,204 85%

Yemen No 59 17%

Zambia Yes 49,389 33% GFATM-UNICEF, USAID-SCMS

Zimbabwe Yes 46,319 27% DFID-SCMS

PROCUREMENT CONSORTIUM FORECAST: COUNTRY SCOPE

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. Optimal: The paediatric ARV formulations that serve all currently recommended preferred and alternative paediatric first and second-line WHO regimens for all paediatric weight-bands (<35kg) Limited Use: Paediatric formulations that may be needed in limited supply during transition periods and/or for special circumstances. Non-essential: Formulations not recommended for procurement (all remaining paediatric formulations not included on optimal and limited use lists).

PROCUREMENT CONSORTIUM FORECAST: IATT FORMULARY PROFILE

Optimal 85%

Optimal - PMTCT 8%

Limited-Use 0%

Non-Essential

7%

Unreviewed 0%

2015 Planned Procurements

PROCUREMENT CONSORTIUM FORECAST: COUNTRY DEMAND BY IATT STANCE

0 500 000 1 000 000 1 500 000 2 000 000 2 500 000 3 000 000 3 500 000

Zimbabwe

Tanzania

Myanmar

Malawi

Kenya

High Volume Countries

Optimal

Optimal - PMTCT

Limited-Use

Non-Essential

PROCUREMENT CONSORTIUM FORECAST: COUNTRY DEMAND BY IATT STANCE

0 100000 200000 300000 400000 500000 600000 700000 800000 900000

Zambia

Vietnam

Uganda

Sri Lanka

Rwanda

Nigeria

Mozambique

Kyrgyzstan

Cote d'Ivoire

Medium Volume Countries

Optimal

Optimal - PMTCT

Limited-Use

Non-Essential

PROCUREMENT CONSORTIUM FORECAST: OPTIMAL PEDIATRIC ARVs

-

1 000 000

2 000 000

3 000 000

4 000 000

5 000 000

6 000 000

7 000 000

ABC/3TC (60/30 mg)Tablet (Disp) - 60

AZT/3TC (60/30 mg)Tablet (Disp) - 60

AZT/3TC/NVP (60/30/50mg) Tablet (Disp) - 60

EFV (200 mg) Tablet(Scored) - 90

HIGH VOLUME OPTIMAL

Consortium


-

100 000

200 000

300 000

400 000

500 000

600 000

700 000

AZT (50/5 mg/ml) Syrup - 100 AZT (50/5 mg/ml) Syrup - 240 NVP (50/5 mg/ml) Syrup - 100 NVP (50/5 mg/ml) Syrup - 240

OPTIMAL PMTCT

Consortium


-

50 000

100 000

150 000

200 000

250 000

300 000

350 000

400 000

450 000

ABC/3TC (120/60mg) Tablet (Disp) -

60

ABC/3TC (60/30 mg)Tablet (Disp) - 30

AZT/ABC/3TC(60/60/30 mg)

Tablet - 60

LPV/r (100/25 mg)Tablet (HS) - 120

LPV/r (100/25 mg)Tablet (HS) - 60

LPV/r (80/20mg/ml) Syrup - 300

LPV/r (80/20mg/ml) Syrup - 60

NVP (50 mg) Tablet(Disp) - 30

NVP (50 mg) Tablet(Disp) - 60

OTHER OPTIMAL

Consortium

PROCUREMENT CONSORTIUM FORECAST: NON-ESSENTIAL PEDIATRIC ARVs

-

50 000

100 000

150 000

200 000

250 000

300 000

350 000

400 000

450 000

500 000

ABC/3TC (60/30 mg)Tablet - 60

AZT (100 mg) Capsule -100

AZT/3TC (60/30 mg)Tablet - 60

EFV (50 mg) Tablet - 30

High Volume Non-Essential Products

Consortium

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

ROAD AHEAD: IMPROVED ENGAGEMENT

paediatric arv procurement working group … · country ethiopia included in papwg forecast nigeria...

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