GDF Diagnostics. John Loeber Procurement Team Manager

Transcription

1 GDF Diagnostics John Loeber Procurement Team Manager Joint UNICEF, UNFPA & WHO Meeting with Manufacturers and Suppliers Copenhagen, Denmark September

2 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 Expandx-TB Project, UNITAID financed, providing New Diagnostics for MDR-TB Executed by GLI, FIND, GDF New Diagnostics to be supplied on a reimbursable basis to GDF clients from

3 GDF Standard Diagnostics - Diagnostic Kits designed by GDF in 2005 / Bright-field Microscopy and (since 2013:) LED Microscopy - Deliveries of approx. 1 million USD p.a. - Kits for preparation of 1000 slides Old Microscope Kit Equipment Starter Kit Consumables Kit Sputum Container Kit New LED Microscope Equipment and Starter Kit Diagnostics and Consumables Kit Sputum Container Kit 3

4 GDF Orders Std. Diagnostics Sales (mln US$) Trend 2013: 2.8 mln US$ 4

5 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 5

6 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 6

7 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 7

8 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. 8

9 TBXpert Project 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 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

10 >220 GeneXperts and 1.4 million Xpert MTB/RIF cartridges in 21 countries, from Procurement by GDF/TB REACH TBXpert Project TB REACH contributing 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

11 TBXpert Project 21 recipient countries

12 EXPAND-TBx Project Narrowing the Gap: Expanding and accelerating access to diagnostics for patients at risk of MDR-TB Procurement and Logistics 12

13 Complementary capacities and responsibilities Global Laboratory Initiative FIND Global Drug Facility 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 Public-private partnership focused on development, evaluation, and accelerated uptake of new diagnostics ISO 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 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 13

14 Objectives 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. 14

15 Recipient countries 15

16 Procurement and logistics data Number of orders placed Value of orders placed in USD Number of shipments delivered ,388 2,874,338 5,204,710 10,553, 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% 16

17 Number of tests delivered Supplier Name of essential reagents BBL MGIT Tubes (7ml) 9, , , , , ,704 BD BACTEC MGIT 960 Supplement Kit 4,900 61,500 92, , , ,089 BACTEC MGIT 960 SIRE kit, 40 test ,080 18,720 43,480 83,011 81,923 Hain GenoType MTBDR plus V2 277, , ,620 SD Rapid test for Detection of MPT 64 10,100 69,900 83,795 83,142 CEPHEID Xpert MTB/RIF 61, ,400 Number of test delivered by method 450, , , , , , , ,000 50, TB CULTURE DST LPA MPT 64 identification test

18 EXPANDx-TB Suppliers Shipments are sent directly from suppliers to countries 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 18

19 Xpert MTB/RIF implementation in EXPAND-TB project 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 Azerbaijan 6 13,860 Ethiopia 6,930 CIDA-Stop TB India 12 23,600 Partnership Myanmar 2 4,620 Swaziland 4 9,240 Uzbekistan 6 13,860 TOTAL 15 countries ,110

20 Improved Ordering Method 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 to be supplied on a reimbursable basis to GDF Clients from 2013 New Diagnostics 20

21 Thank You for your attention 21