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

1

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

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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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