Global Forum objectives and status of the global roll-out of Xpert MTB/RIF

Size: px

Start display at page:

Download "Global Forum objectives and status of the global roll-out of Xpert MTB/RIF"

Frederica Glenn
5 years ago
Views:

1 Photo: Riccardo Venturi Global Forum objectives and status of the global roll-out of Xpert MTB/RIF Wayne van Gemert WHO Global TB Programme, Geneva Global Forum of Xpert MTB/RIF Implementers Geneva, 1-2 May 2014

2 Global Forum: Objectives To provide a forum for the exchange of experiences and lessons learned on implementation of Xpert MTB/RIF in different epidemiological and resource settings, with different patient groups, and in different algorithms using complementary tools To share up-to-date information on the use of Xpert MTB/RIF in line with updated WHO policy guidance, including for detection of paediatric and extrapulmonary TB To share partner innovations in expanding access to new patient groups and in development of new tools

3 Topics of the Forum Global Forum: Agenda Newly recommended uses of Xpert MTB/RIF Procurement of Xpert MTB/RIF: advancements Optimizing use and measuring impact of Xpert MTB/RIF for PLHIV Country and partner experiences in implementing Xpert MTB/RIF Monitoring and evaluation: Electronic recording & reporting tools Expanding access

4 1,200,000 1,000,000 Quarterly number of Xpert MTB/RIF cartridges procured under concessional pricing 1,071, ,000 Cartridges 600, , ,000 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q Data provided by FIND 2014

Cartridges 1,200,000 1,000,000 400,000 Quarterly number of Xpert MTB/RIF cartridges procured under concessional pricing Q4 2012-Q2 2013: Global shortage in Xpert MTB/RIF cartridges August 2012:

5 Cartridges 1,200,000 1,000, ,000 Quarterly number of Xpert MTB/RIF cartridges procured under concessional pricing Q Q2 2013: Global shortage in Xpert MTB/RIF cartridges August 2012: Buy-down with the 800,000 manufacturer by PEPFAR, USAID, UNITAID and Bill & Melinda Gates Foundation the 600,000 price of the cartridge dropped to 9.98 USD in 145 eligible countries 1,071, ,000 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q Data provided by FIND 2014

6 1,200,000 1,000,000 Quarterly number of Xpert MTB/RIF cartridges procured under concessional pricing 1,071,370 Cartridges 800, ,000 Cartridges procured by the rest of the world 400, ,000 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q Data provided by FIND 2014 Cartridges procured by South Africa

2500 Quarterly number of Xpert MTB/RIF modules procured under concessional pricing 2000 Modules 1500 1000 500 Modules procured by the

7 2500 Quarterly number of Xpert MTB/RIF modules procured under concessional pricing 2000 Modules Modules procured by the rest of the world 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q Modules procured by South Africa Data provided by FIND

8 Xpert MTB/RIF global landscape today 2,343 GeneXperts (12,103 modules) and 6.3 million Xpert MTB/RIF cartridgeshave been procured in the public sector in 104 of the 145 countries eligible for concessional prices, as of March 2014 Number of GeneXpert modules procured Not eligible Data provided by FIND

9 Xpert MTB/RIF global landscape today 2,343 GeneXperts (12,103 modules) and 6.3 million Xpert MTB/RIF cartridgeshave been procured in the public sector in 104 of the 145 countries eligible for concessional prices, as of March 2014 Total number of modules (and GeneXperts), as of March 2013: 2,841 (262) South Africa 250 (63) India 194 (51) Pakistan 164 (32) Zimbabwe 152 (38) Nigeria 150 (38) Kenya 148 (37) Botswana 108 (24) Philippines 102 (27) Viet Nam 92 (24) Tanzania 86 (23) Zambia 84 (21) Swaziland 80 (20) Malawi 76 (19) Brazil Total number of modules (and GeneXperts), as of March 2014: 4,117 (342) South Africa 716 (179) Brazil 716 (179) China 554 (145) India 392 (98) Nigeria 376 (71) Bangladesh 368 (89) Kenya 294 (76) Pakistan 288 (63) Zimbabwe 284 (71) Indonesia 284 (68) Philippines 192 (49) Tanzania 188 (51) Uganda 149 (40) Ukraine Data provided by FIND

eg, What to do when Xpert MTB/RIF detects rifampicin resistance in a patient not considered

10 WHO Policy update on Xpert MTB/RIF and Implementation manual Including: Updated guidance on selection of target patient groups and positioning of machines Interpreting test results: eg, What to do when Xpert MTB/RIF detects rifampicin resistance in a patient not considered to be at risk? Improved budgeting guidance Annex of SOPs for processing extrapulmonary specimens

GLI training package As a TB CARE I project and in collaboration with GLI partners, training modules on Xpert MTB/RIF have been developed, combining modules and products of KNCV, FIND and Cepheid

11 GLI training package As a TB CARE I project and in collaboration with GLI partners, training modules on Xpert MTB/RIF have been developed, combining modules and products of KNCV, FIND and Cepheid Modules: Overview of TB and TB diagnostics Biosafety Collection and transportation of specimens Supplies management Installation GeneXpert technology and Xpert MTB/RIF procedures Results interpretation and database management Recording and reporting Troubleshooting Maintenance Clinical guide to Xpert MTB/RIF Access them here: Core development team: - KNCV (Valentina Anisimova, Sanne van Kampen) - FIND (Heidi Albert) - CDC (Heather Alexander, Tom Shinnick) - USAID (Amy Piatek) - WHO (Diego Zallocco, Chris Gilpin, Wayne van Gemert)

12 Information from national TB control programmesand partners on sites of instruments, plans for procurement of instruments NTPs and partners in 56 countries have shared information on sites of instruments and plans for procurement

instruments, plans for procuremen www.who.

13 Information from national TB control programmesand partners on sites of instruments, plans for procuremen NTPs and partners in 56 countries have shared information on sites of instruments and plans for procurement

2013 Revised WHO definitions and reporting framework Prompted largely by the need to accommodate Xpert MTB/RIF into revised case and outcome definitions 2013 WHO guidance: Examples of revised forms

14 2013 Revised WHO definitions and reporting framework Prompted largely by the need to accommodate Xpert MTB/RIF into revised case and outcome definitions 2013 WHO guidance: Examples of revised forms and lab registers Quarterly reporting focuses on bacteriological confirmation (smear, culture or Xpert-positive) instead of smear positivity Countries currently reporting 2013 data to WHO based on the new definitions; data to be published in 2014 WHO Global Report

15 Unified forecasting initiative Manufacturing problems at Cepheid while scaling up to meet growing demand resulted in a global shortage of Xpert MTB/RIF cartridges in Q Q Quarterly forecasts of orders from major procurers, including South Africa, Brazil, Global Fund, PEPFAR, USAID, TBXpert, TB REACH, EXPAND-TB, GDF and MSF, are collected by the WHO Global TB Programme Unified forecasting aids Cepheid in planning to meet demand, and allows for increased shared leverage among partners to ensure Cepheid timely responds to placed orders that had been forecasted

16 $25.9 million UNITAID-funded project for establishment of 234 GeneXperts and 1.4 million Xpert MTB/RIF cartridges in 21 countries ( ) Managed by the WHO Global TB Programme and Stop TB Partnership, with partners: TB REACH, GLI, GDF, EXPAND-TB, African Society for Laboratory Medicine (ASLM), Interactive Research and Development (IRD) TBXpert Project 222 GeneXperts procured already by end of 2013 Installmentof machines at decentralized health centres for rapid detection of TB, HIV-associated TB, and rifampicin-resistant TB at or close to point-of-care Innovative use of machines, including in social business models

17 Acknowledgements Laboratories, diagnostics and drug resistance unit, WHO Global TB Programme: Chris Gilpin, Fuad Mirzayev, Jean Iragena, Diego Zallocco, Denisa Pohancanikova, Henriikka Weiss, Fraser Wares, Ernesto Jaramillo, Dennis Falzon, Linh Nhat Nguyen, Lynne Harrop, Karin Weyer Thank you Wayne van Gemert WHO Global TB Programme, Geneva