Photo: Riccardo Venturi Unified Xpert MTB/RIF Forecasting Initiative Wayne van Gemert WHO Global TB Programme, Geneva WHO ANNUAL MEETING WITH HIV DIAGNOSTIC MANUFACTURERS AND STAKEHOLDERS 11 March 2016
and rifampicin resistance in <2 hours Relatively low biosafety precautions required + relatively simple to use = can be placed at lower levels of laboratory networks (but not POC) Manufactured by Cepheid (Sunnyvale, California USA) No generic or similar products today Background on the Xpert technology Xpert MTB/RIF detects TB (sensitivity significantly higher than microscopy) Xpert MTB/RIF cartridge In December 2010 WHO recommended Xpert MTB/RIF as the initial diagnostic test for PLHIV suspected of having TB, GeneXpert and for people suspected of having drugresistant TB; as of 2013, conditional machine recommendation for its use as the initial diagnostic test for all people suspected of having TB
GeneXpert machine can be used to test for other diseases and conditions (including HIV viral load*, EID*) United States CE-IVD Available Now 2015 16 2017 18 2019 20 HAI MRSA Surveillance SA Nasal Complete C. diff (US only) C. diff/epi Norovirus vana for VRE (US only) vana/b for VRE (CE-IVD only) MRSA/SA SSTI MRSA/SA BC Carba-R (CE-IVD only) Carba-R Group A Strep Trichomonas HIV Viral Load Breast CA Stratifier BCR-ABL Ultra Pertussis HPV GBS Ultra HCV Viral Load HBV Viral Load CMV Viral Load Bladder CA Monitor Bladder CA Symptomatic GI Panel Meningitis/Encephalitis Vaginitis/Vaginosis CLL Monitor Pancreatic CA Early Detect Breast CA Monitor Breast CA Resistance Monitor Breast CA Signature 23 31 39 CID MTB/RIF EV Flu Flu A/B/RSV Ebola (EUA/WHO) Women s/ Sexual Health Virology Oncology/ Genetics CT (CE-IVD only) CT/NG Trichomonas (CE-IVD only) GBS & GBS Lim Broth (US only) HPV (CE-IVD only) HIV Qualitative (CE-IVD only) HIV Viral Load (CE-IVD only) HCV Viral Load (CE-IVD only) BCR-ABL Monitor (CE-IVD only) FII & FV MTB/RIF Ultra Group A Strep HBV Viral Load BCR-ABL Ultra Bladder CA Breast CA Stratifier 28 Pertussis MTB XDR GI Panel Sepsis Panel Vaginitis/Vaginosis GBS Ultra CMV Viral Load Breast CA Signature CLL Monitor Breast CA Monitor Meningitis/Encephalitis Pancreatic CA Early Detect Pancreatic CA Monitor Breast CA Resistance Monitor 38 42 Source of information and timeline: Cepheid, Dec 2015 * Pending WHO Prequalification (as of March 2016)
Rapid adoption of Xpert MTB/RIF by countries Dec 2010 99 GeneXperts (524 modules) in the public sector in 23 countries 3,763 GeneXperts (17,883 modules) in the public sector in 116 countries Q1 2011 Q4 2014 Data: FIND/Cepheid
Xpert MTB/RIF cartridges 1 400 000 Xpert MTB/RIF cartridges procured under concessional prices 1 200 000 1 000 000 Manufacturing unable to meet global demand 800 000 600 000 Partner buydown of cartridges from $16.86 to $9.98 400 000 200 000 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2010 2011 2012 Data sources: FIND/Cepheid 2013 2014
Xpert MTB/RIF cartridges 1 400 000 1 200 000 Xpert MTB/RIF cartridges procured under concessional prices South Africa (MoH, Global Fund, USAID, PEPFAR, others) 1 000 000 800 000 600 000 400 000 56% of all cartridges have been procured by South Africa, which has replaced microscopy with Xpert as the initial diagnostic test for all people suspected of having TB 200 000 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2010 2011 2012 2013 Data sources: FIND/Cepheid (data by country and overall); WHO (data by donor) 2014
Xpert MTB/RIF cartridges 1 400 000 1 200 000 1 000 000 800 000 600 000 400 000 Xpert MTB/RIF cartridges procured under concessional prices Others (Global Fund, USAID, PEPFAR, MSF, etc.) India: USAID, IPAQT, PEPFAR, others IPAQT, others India: UNITAID (TBXpert/EXPAND-TB) UNITAID (TBXpert/EXPAND-TB) DFATD Canada (TB REACH/EXPAND-TB) Brazil (MoH) China (Global Fund) South Africa (MoH, Global Fund, USAID, PEPFAR, others) 200 000 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2010 2011 2012 2013 Data sources: FIND/Cepheid (data by country and overall); WHO (data by donor) 2014
Modules GeneXpert modules procured under concessional prices 4 000 3 500 3 000 2 500 2 000 1 500 1 000 500 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2010 2011 2012 2013 2014
Background of the forecasting initiative April 2013: Prompted by the global shortage in cartridges, WHO Global TB Programme together with the Stop TB Partnership s GDF and donors involved in the buy-down (PEPFAR, USAID, UNITAID and Gates Foundation) initiated the Unified forecasting initiative On a quarterly basis, data are collected from major public procurers and largest countries on cartridge orders forecasted to be placed in the coming year Excel sheet-based, disaggregated by country and by 6-month semester Justification: Unified forecasting aids the manufacturer in planning to meet demand, and allows for increased shared leverage among partners to ensure the manufacturer timely responds to placed orders that had been forecasted
Contributors to the initiative South Africa NHLS Global Fund UNDP TBXpert and EXPAND-TB projects/unitaid USAID MSF GDF, including TB REACH Brazil NTP India NTP
Way forward: Outcomes of December 2015 stakeholder meeting The unified forecasting initiative continues to be relevant However, reliable supply from Cepheid in recent years has resulted in fewer contributions of forecasts from partners and countries Upcoming release of the more sensitive Ultra cartridge: implications of shifting of manufacturing from MTB/RIF to Ultra, while country registration of Ultra is ongoing When PQed, Xpert HIV cartridges may result in significant interest and new procurement stakeholders affecting the supply chain Global Fund started asking country portfolio managers in Q4 2015 whether there are planned procurements of Xpert HIV VL cartridges New multi-disease POC platforms from other manufacturers are on the horizon; the scope will need to expand and merge with other initiatives Cooperation with HIV stakeholders will be important going forward
Thank you Wayne van Gemert WHO Global TB Programme vangemertw@who.int