Outcomes and follow-up of the GDF GeneXpert procurement stakeholders meeting, Paris, October 2013

Transcription

1 Outcomes and follow-up of the GDF GeneXpert procurement stakeholders meeting, Paris, October 2013 Thomas Vergès GDF Country Support Officer EXPANDx-TB/Diagnostics

2 What is the Global Drug Facility? An initiative of the Stop TB Partnership (2001), hosted in WHO and managed by the Stop TB Partnership secretariat An operating mechanism to support the Stop TB Strategy: expanding accessto quality-assured first(fld)and second-line TB drugs(sld) and diagnostics, contributing to the development of sustainable procurement and supply management for countries in need GDF began supplying FLDs in 2001, and in 2008 added the supply of SLDs, pediatric TB medicines and new diagnostics liquid culture, LPA and GeneXpert 2

3 Diagnostics methods available via GDF Number of diagnostics delivered 2007 April 2014 TB on Liquid Culture : 809,600 tests DST on Liquid Culture : 136,720 tests Line Probe Assay: 645,600 tests Xpert MTB/RIF: 1,299,910 tests Sputum container: 17,105,000 units Source : 3

4 GDF DIAGNOSTICS PROCUREMENT ALL FEE INCLUDED IN USD -PER SUPPLIER -PER YEAR $30,000,000 $25,000,000 TTM GDF SUPPLIERS BD : Liquid Culture $20,000,000 $15,000,000 TTM Svizera HAIN CEPHEID : Xpert MTB/Rif HAIN : Line Probe Assay $10,000,000 $5,000,000 $- TTM Svizera Svizera Cepheid SAS HAIN Cepheid SAS HAIN TTM HAIN TTM Cepheid SAS Cepheid SAS Cepheid SAS Svizera HAIN BD BD BD BD BD SVIZERA: Microscopy Kits TTM : General Lab items Diagnostics is representing in 2012 and 2013 approximately 13% of GDF procurement 4

5 GeneXpert procurement stakeholders meeting Procurement and Logistics Discussion points 5

6 CHANGE OF PACKAGING Change of the packaging from 10 Test pack to 50 Test pack Description Xpert MTB/RIF, IVD, CE-IVD, 10 Tests Xpert MTB/RIF, IVD, CE-IVD, 50 Tests Unit Dimensions cm Unit Weight Kg Pallets Nbof kits Pallets Dimensions Pallets Weight Kg 29*14* *100* *27* *100*

7 CHANGE OF PACKAGING - STORAGE Change of the packaging from 10 Test pack to 50 Test pack Gross weight per test has decreased of 22% and volume of 65% Description Number of test per pallets Pallets Dimensions Pallets Weight Kg Gross weight per test ADVANTAGE FOR A LABORATORY : In a storage room of 10 M 2, you can store 6 pallets With 50 test pack : 18,000 tests can be stored With 10 test pack : 8,640 tests can be stored Gross volume per Test XpertMTB/RIF, IVD, CE-IVD, 10 Tests 1, *100* g per test 1.25 dm3 XpertMTB/RIF, IVD, CE-IVD, 50 Tests 3, *100* g per test 0.44 dm3 7

8 CHANGE OF PACKAGING & FREIGHT COST Change of the packaging from 10 Test pack to 50 Test pack Average freight decrease for GDF orders between 15 to 20% Number of Tests Packaging Freight cost 10 Test Pack 50 Test Pack 10 Test Pack 50 Test Pack Saving GEORGIA Pallets Kg 4 Pallets Kg $ 7,600 $ 3,270 57% INDIA Pallet - 45Kg 1 Pallet Kg $ 420 $ % Change of the packaging has a big impact for shipment over 6000 tests Air freight rate decreases for each threshold of weight with a minimum fee Example : India Shipment of 50 test pack For a shipment of 100 packs, freight cost per cartridges is 0.57 USD For a shipment of 48 packs, freight cost per cartridges is 0.83 USD 8

9 STABILITY TESTING Participants of the GeneXpert Stakeholders meeting request more data related to shipment at high or low temperatures and different humidity levels. Information in package insert of CGXMTB/RIF-50 kit : Store the Xpert MTB/RIF cartridges and reagents at 2 to 28 C. The cartridges are stable up to 2 weeks at 2 to 48 C after opening the pouch Additional information received from CEPHEID on shipping study in both summer and winter conditions to define shelf life based on real time data. Each protocol is based on a total of 7 days, with several variations of temperature to simulate shipments, and with the 5 last days at 50 C (summer protocol ) or at minus 18 C (winter protocol). The tests which have been following these shipping simulations, are then tested at T0, then stored at 5 or 25 or 35 C, (simulating customer storage) and then tested after 3, 12, 24,36 months. 9

10 WARRANTY AND SUPPORT Request to have a white paper that documents what is included and what is not included in the price of the warranty Warranty Extension agreement has been drafted and cover - Preventive maintenance (Calibration) - Modules swap when required - Exchange or repair of any defective parts - Shipping Charges CIP local airport Document to direct you to the right contact inside the company for : Quotations/Orders/ Supplies Program Management Training Centre Hotline 10