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

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1 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

2 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

3 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

4 2013 IATT OPTIMAL PAEDIATRIC ARV FORMULARY 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 4

5 PROCUREMENT VOLUMES OF THE PROCUREMENT CONSORTIUM *Based on 2011 IATT List Formulation 2013 TOTAL 9,023,695 Optimal* 7,686,211 AZT/3TC/NVP (60/30/50 mg) Tablet (Disp) ,480,902 NVP (50/5 mg/ml) Syrup ,750 ABC/3TC (60/30 mg) Tablet (Disp) ,178 NVP (50 mg) Tablet (Disp) ,880 EFV (200 mg) Tablet (Scored) ,868 AZT/3TC (60/30 mg) Tablet (Disp) ,865 LPV/r (100/25 mg) Tablet (HS) ,396 AZT (50/5 mg/ml) Syrup ,419 d4t/3tc/nvp (6/30/50 mg) Tablet (Disp) ,290 NVP (50/5 mg/ml) Syrup ,285 NVP (50/5 mg/ml) Syrup ,727 d4t/3tc (6/30 mg) Tablet (Disp) ,892 LPV/r (80/20 mg/ml) Syrup ,684 AZT (50/5 mg/ml) Syrup ,338 ABC (60 mg) Tablet (Disp) ,610 ddi (25 mg) Tablet (disp) ,506 LPV/r (80/20 mg/ml) Syrup ,823 NVP (50 mg) Tablet (Disp) ,900 ddi (200 mg) Capsule (EC) ,596 ddi (125 mg) Capsule (EC) ,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) ,321,816 NVP (50/5 mg/ml) Syrup ,820,485 AZT/3TC (60/30 mg) Tablet (Disp) ,337 ABC/3TC (60/30 mg) Tablet (Disp) ,412 NVP (50/5 mg/ml) Syrup ,328 EFV (200 mg) Tablet (Scored) ,926 LPV/r (100/25 mg) Tablet (HS) ,780 NVP (50/5 mg/ml) Syrup ,122 NVP (50 mg) Tablet (Disp) ,139 AZT (50/5 mg/ml) Syrup ,936 LPV/r (80/20 mg/ml) Syrup ,881 NVP (50 mg) Tablet (Disp) ,242 LPV/r (80/20 mg/ml) Syrup ,676 AZT (50/5 mg/ml) Syrup ,021 AZT (50/5 mg/ml) Syrup ,886 d4t/3tc (6/30 mg) Tablet (Disp) ,887 d4t/3tc/nvp (6/30/50 mg) Tablet (Disp) ,000 ddi (25 mg) Tablet (disp) ,935 ddi (200 mg) Capsule (EC) ,200 d4t/3tc/nvp (12/60/100 mg) Tablet (Disp)

6 FORECAST 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

7 PROCUREMENT CONSORTIUM FORECAST: COUNTRY SCOPE Country Number of Included in Children on PAPWG forecast ARVs* ART ⱡ Pediatric ARV Procurement Sources Coverage* Afghanistan Yes 16 32% GFATM-UNICEF Algeria No % 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 % 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 % Egypt No 53 22% El Salvador Yes % GFATM-UNICEF Eritrea No % Ethiopia No 18,931 9% Fiji No - - Gabon No % Gambia No % Georgia Yes 45 74% GFATM-PPM Ghana No 3,907 11% Guatemala No % 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 % GFATM-PPM India No 41,638 30% Indonesia Yes 1,631 0% GFATM-PPM Iran No 172 8% Jamaica No % Kenya Yes 60,141 31% GFATM-KEMSA Kyrgyzstan Yes % GFATM-UNICEF Lao No % 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 % Maldives No - - Mali Yes 2,001 13% Mauritania Yes - - GFATM-PPM Mauritius No - - Mexico No 1,802 80% Morocco Yes % 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 % GFATM-PPM Nicaragua No % Niger Yes 554 7% GFATM-PPM Nigeria Yes 47,313 12% GFATM-PPM, USAID-SCMS Pakistan No 70 4% Palestine No - - Panama No % Papua New Guinea No % Paraguay No % Peru No % Philippines Yes - - GFATM-PPM Rep. of Moldova No 82 69% Rwanda Yes - - USAID-SCMS S.Tome&Principe No 11 3% Senegal No % 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 % 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 % 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

8 PROCUREMENT CONSORTIUM FORECAST: IATT FORMULARY PROFILE 2015 Planned Procurements Optimal - PMTCT 8% Limited-Use 0% Unreviewed 0% Non- Essential 7% 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) Optimal 85% 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).

9 PROCUREMENT CONSORTIUM FORECAST: COUNTRY DEMAND BY IATT STANCE Kenya High Volume Countries Malawi Myanmar Tanzania Optimal Optimal - PMTCT Limited-Use Non-Essential Zimbabwe

10 PROCUREMENT CONSORTIUM FORECAST: COUNTRY DEMAND BY IATT STANCE Cote d'ivoire Medium Volume Countries Kyrgyzstan Mozambique Nigeria Rwanda Sri Lanka Optimal Optimal - PMTCT Limited-Use Non-Essential Uganda Vietnam Zambia

11 PROCUREMENT CONSORTIUM FORECAST: OPTIMAL PEDIATRIC ARVs HIGH VOLUME OPTIMAL ABC/3TC (60/30 mg) Tablet (Disp) - 60 AZT/3TC (60/30 mg) Tablet (Disp) - 60 AZT/3TC/NVP (60/30/50 mg) Tablet (Disp) - 60 EFV (200 mg) Tablet (Scored) - 90 Consortium

12 PROCUREMENT CONSORTIUM FORECAST: OPTIMAL PEDIATRIC ARVs OPTIMAL PMTCT AZT (50/5 mg/ml) Syrup AZT (50/5 mg/ml) Syrup NVP (50/5 mg/ml) Syrup NVP (50/5 mg/ml) Syrup Consortium

13 PROCUREMENT CONSORTIUM FORECAST: OPTIMAL PEDIATRIC ARVs OTHER OPTIMAL ABC/3TC (120/60 ABC/3TC (60/30 mg) mg) Tablet (Disp) - Tablet (Disp) AZT/ABC/3TC (60/60/30 mg) Tablet - 60 LPV/r (100/25 mg) Tablet (HS) LPV/r (100/25 mg) Tablet (HS) - 60 LPV/r (80/20 mg/ml) Syrup LPV/r (80/20 mg/ml) Syrup - 60 NVP (50 mg) Tablet (Disp) - 30 NVP (50 mg) Tablet (Disp) - 60 Consortium

14 PROCUREMENT CONSORTIUM FORECAST: NON- ESSENTIAL PEDIATRIC ARVs High Volume Non-Essential Products ABC/3TC (60/30 mg) Tablet - 60 AZT (100 mg) Capsule AZT/3TC (60/30 mg) Tablet - 60 EFV (50 mg) Tablet - 30 Consortium

15 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

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