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GDF Diagnostics John Loeber
Procurement Team Manager
Joint UNICEF, UNFPA & WHO Meeting with Manufacturers and Suppliers
Copenhagen, Denmark September 2013
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GDF Diagnostics Overview
1. Standard Diagnostics
Provided to GDF clients using own funding GDF Diagnostic Kits (Microscope, Equipment / Start-Up, Consumables, Sputum Containers)
2. GeneXpert (Cepheid Inc.)
• TB REACH Initiative / GDF, financed by CIDA Rollout to TB REACH Grantees from mid 2011
• TBXpert Project, UNITAID financed Consortium among seven partners incl. GDF 2013 - 2015
3. Expandx-TB Project, UNITAID financed, providing New Diagnostics for MDR-TB Executed by GLI, FIND, GDF 2009 – 2014 New Diagnostics to be supplied on a reimbursable basis to GDF clients from 2013
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- Diagnostic Kits designed by GDF in 2005 / 2006 - Bright-field Microscopy and (since 2013:) LED Microscopy - Deliveries of approx. 1 million USD p.a.
- Kits for preparation of 1000 slides
GDF Standard Diagnostics
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Old New Microscope Kit LED Microscope Equipment Starter Kit Equipment and Starter Kit Consumables Kit Diagnostics and
Consumables Kit Sputum Container Kit Sputum Container Kit
GDF Orders – Std. Diagnostics
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Trend 2013: 2.8 mln US$ 0
0.5
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1.5
2
2.5
2012 2013
2.4
1.3
Sales (mln US$)
20122013
GeneXpert TB REACH /GDF
• Globally, TB REACH /GDF is the largest GeneXpert pooled procurement mechanism
• Approx. 300 machines and 500,000 cartridges ordered in 21 months for delivery to 35 countries
• Value of orders placed: 10.3 million USD • All shipments on average delivered within target arrival date; median order lead time: 55 days • GeneXpert procured at approximately 25 % of the market price. • Innovative business model established in 2011, widely acknowledged by
implementers, donors • Dedicated electronic Order Management System (OMS) • Standard Operating Procedure (SOP) agreed with Cepheid • Technical Assistance by TB REACH / GDF
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GeneXpert Services
Direct support (free of charge, via internet / web) • Installation, set up, usage of equipment • Training, technical counsel
Additional, payable services • Installation support: Unpacking, power up, start up • Training in theoretical and practical instruction on principle use, basic regular
maintenance • After sales technical support, services (through certified local service provider) Covers onsite demonstration, maintenance, calibration Warranty matters: dealt with by Cepheid and certified local service provider
WHO/TBP Long-term Agreement with Cepheid on strategic aspects such as forecasts for optimising production planning, preferential pricing policy, SOPs, innovations
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GeneXpert Order Process
1. Signing of Technical Agreement / Product Request Form Identifying items, quantities, requested delivery dates. Note: limited shelf life of cartridges (6 – 9 months) implies 2 – 3 installments / year. Site preparedness, deployment plans and diagnostic algorithms, consumption rates are also examined.
2. GDF provides a Cost Estimate to the Client, based on quote from Cepheid. Includes transport, insurance. Currently, TB REACH/GDF are not charging a handling fee.
3. Client transfers funds 4. Order placed with Cepheid 5. Monitoring and expediting of order by GDF
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GeneXpert Order Process (cont.)
6. GDF provides shipment pre-advice to Client 7. Delivery at port of entry (airport) 8. The client is responsible for taking delivery,
import / customs clearance. On request, GDF provides a Gift Certificate to facilitate the process.
9. Post-delivery monitoring performed by WHO Stop TB Department, TB REACH and partners
10.GDF issues a Statement of Account to Client, indicating remaining balance, if any.
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• 25.9 million USD UNITAID-funded project for procurement of GeneXperts and Xpert MTB/RIF cartridges
• Consortium: WHO Stop TB Department, Stop TB Partnership, Global Laboratory Initiative (GLI), TB REACH, Global Drug Facility (GDF), EXPAND-TB, African Society for Laboratory Medicine (ASLM), Interactive Research and Development (IRD)
• Project Objectives:
– To reduce the cartridge price from 16.86 USD to 9.98 USD to generate demand and create a sustainable market
– To rapidly scale-up implementation of Xpert MTB/RIF in target countries using effective diagnostic algorithms
– To develop and establish innovative PPM models to accelerate uptake and increase demand
TBXpert Project
• >220 GeneXperts and 1.4 million Xpert MTB/RIF cartridges in 21 countries, from 2013-2015
• Procurement by GDF/TB REACH
• TB REACH contributing 10-12 million USD for support of implementation at selected sites (according to the TB REACH Proposal Review Committee)
• IRD to establish sustainable social business models in Jakarta, Dhaka and Karachi (25 GeneXperts in each city)
• ASLM to coordinate technical assistance support in Congo, Ethiopia, Tanzania, Mozambique, Kenya
• Cooperation with PEPFAR, USAID, CDC, Supranational Reference Laboratories and other partners to ensure provision of technical assistance and treatment of patients diagnosed with rifampicin-resistance
TBXpert Project
21 recipient countries
TBXpert Project
EXPAND-TBx Project
Narrowing the Gap: Expanding and accelerating access to diagnostics for patients at risk of MDR-TB
Procurement and Logistics
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Global Laboratory Initiative Global Drug Facility FIND
• Network of international partners dedicated to laboratory strengthening
• Components include: - Policy guidance - Capacity development and
coordination - Integration with other
laboratory networks - Standardized quality
assurance - Coordination of technical
assistance - Knowledge sharing
• Ensures access to anti-TB drugs and diagnostics at lowest possible price
• Provides procurement services • Technical expertise in
managing and monitoring of commodities
• Has achieved cost-containment for first-line TB drugs under UNITAID
• Current projects with UNITAID also include scale-up of procurement for drugs to treat MDR-TB and paediatric TB
• Public-private partnership focused on development, evaluation, and accelerated uptake of new diagnostics
• ISO 13485 certified • Extensive experience with
clinical trials of new diagnostics in developing countries
• Will ensure access to new diagnostics including: TB liquid culture Immunoassay for species
identification Line probe assay
Complementary capacities and responsibilities
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Operational objectives :
Improve control of MDR-TB through expanding and accelerating access to new diagnostic technologies
Improve market dynamics by increasing number of manufacturers and driving prices down Ensure that these tools are properly integrated within TB control programmes through complementary support from other global health partners
Final Objective: identify 35% of all MDR-TB cases in the 27 countries covered under the project.
Objectives
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Recipient countries
Procurement and logistics data
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2009 2010 2011 2012 Number of orders
placed 31 41 85 129
Value of orders placed in USD 850,388 2,874,338 5,204,710 10,553,731
Number of shipments delivered 2 104 266 514
Procurement Budget Total Expenses Total Budget % of Expenses
A-Equipment Cost 7,259,245 13,373,581 54%
B-Consumables and reagents 8,793,925 31,799,695 28%
C-Essential Supplies (Bio-safety) 3,710,482 7,580,483 49%
Grand Total 19,763,653 52,753,759 37%
Number of tests delivered
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Supplier Name of essential reagents 2009 2010 2011 2012 2013 2014
BD BBL MGIT Tubes (7ml) 9,000 113,400 166,400 441,400 810,379 818,704 BACTEC MGIT 960 Supplement Kit 4,900 61,500 92,800 257,500 395,324 409,089 BACTEC MGIT 960 SIRE kit, 40 test 840 20,080 18,720 43,480 83,011 81,923
Hain GenoType MTBDR plus V2 277,440 371,265 340,620 SD Rapid test for Detection of MPT 64 10,100 69,900 83,795 83,142 CEPHEID Xpert MTB/RIF 61,600 169,400
0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
400,000
450,000
2009 2010 2011 2012 2013 2014
Number of test delivered by method
TB CULTURE DST LPA MPT 64 identification test
Example of shipments
Normal cargo Twincubator GT Blot 48
BACTEC 960 system, AST Carrier set…
All generic TB laboratory items
Rapid Speciation test sent by DHL
Cool cargo (+2-8°C) GenoType® MTBDRplus V2
SIRE Kits OADC/PANTA Kits
Second line drugs for laboratory use
Normal cargo (IVD) BD MGIT 7ml tubes
Dangerous cargo Ethanol, Formalin…
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Shipments are sent directly from suppliers to countries
EXPANDx-TB Suppliers
Funds Country GeneXperts Xpert MTB/RIF Cartridges
UNITAID
Azerbaijan 4 26,400 Cameroun 3 19,800 Côte d'Ivoire 3 19,800 Georgia 4 26,400 Haiti 2 13,200 Kazakhstan 6 39,600 Lesotho 2 13,200 Rwanda 5 33,000 Senegal 3 19,800 Tajikistan 3 19,800
CIDA-Stop TB Partnership
Azerbaijan 6 13,860 Ethiopia 6,930 India 12 23,600 Myanmar 2 4,620 Swaziland 4 9,240 Uzbekistan 6 13,860
TOTAL 15 countries 65 303,110
Xpert MTB/RIF implementation in EXPAND-TB project
• Delivery Schedule is established : • One order every 9 months • Specific ordering month per country • Delivery lead time calculated based on experience
• Orders are drafted based on
• Calculation tool developed for EXPANDx-TB • Number of tests to be performed per method • New MoU budget • Inventory of laboratory stock (if available)
New Diagnostics
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Improved Ordering Method
New Diagnostics to be supplied on a reimbursable basis to GDF Clients from 2013
Thank You for your attention
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