GLOBAL TB
PROGRAMME
Unified Xpert MTB/RIF Forecasting Initiative
Photo: Riccardo Venturi
Wayne van Gemert
WHO Global TB Programme, Geneva
WHO ANNUAL MEETING WITH
HIV DIAGNOSTIC MANUFACTURERS AND STAKEHOLDERS
11 March 2016
GLOBAL TB
PROGRAMME
• 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
Xpert® MTB/RIF cartridge
GeneXpert® machine
• In December 2010 WHO recommended Xpert MTB/RIF as the initial diagnostic test for PLHIV suspected of having TB, and for people suspected of having drug-resistant TB; as of 2013, conditional recommendation for its use as the initial diagnostic test for all people suspected of having TB
• Xpert® MTB/RIF detects TB (sensitivity significantly higher than microscopy) and rifampicin resistance in <2 hours
Background on the Xpert technology
28
Carba-R
Group A Strep
Trichomonas
HIV Viral Load
Breast CA Stratifier
BCR-ABL Ultra
GeneXpert machine can be used to test for other diseases and conditions (including HIV viral load*, EID*)
Pertussis
HPV
GBS Ultra
HCV Viral Load
HBV Viral Load
CMV Viral Load
Bladder CA Monitor
Bladder CA Symptomatic
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) MTB/RIF EV Flu Flu A/B/RSV Ebola (EUA/WHO) 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
Pertussis
MTB XDR
GI Panel
Sepsis Panel
Vaginitis/Vaginosis
GBS Ultra
CMV Viral Load
Breast CA Signature
CLL Monitor
Breast CA Monitor
GI Panel
Meningitis/Encephalitis
Vaginitis/Vaginosis
CLL Monitor
Pancreatic CA Early Detect
Breast CA Monitor
Breast CA Resistance Monitor
Breast CA Signature
Meningitis/Encephalitis
Pancreatic CA Early Detect
Pancreatic CA Monitor
Breast CA Resistance Monitor
HAI
CID
Virology
Women’s/ Sexual Health
Oncology/Genetics
Un
ite
d S
tate
s
CE
-IV
D
2015–16 2017–18 2019–20 Available Now
23 31 39
38 42
Source of information and timeline: Cepheid, Dec 2015
* Pending WHO Prequalification (as of March 2016)
GLOBAL TB
PROGRAMME
Rapid adoption of Xpert MTB/RIF by countries
Data: FIND/Cepheid
Dec 2010
Q1 2011
Q4 2014
99 GeneXperts (524 modules)
in the public sector in 23 countries
3,763 GeneXperts (17,883 modules)
in the public sector in 116 countries
GLOBAL TB
PROGRAMME
0
200 000
400 000
600 000
800 000
1 000 000
1 200 000
1 400 000
Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Xp
ert
MTB
/RIF
car
trid
ges
2014 2013 2012 2011 2010
Xpert MTB/RIF cartridges procured under concessional prices
Data sources: FIND/Cepheid
Partner buydown of cartridges from $16.86 to $9.98
Manufacturing unable to meet global demand
GLOBAL TB
PROGRAMME
0
200 000
400 000
600 000
800 000
1 000 000
1 200 000
1 400 000
Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
South Africa (MoH, Global Fund,USAID, PEPFAR, others)
Xp
ert
MTB
/RIF
car
trid
ges
2014 2013 2012 2011 2010 Data sources: FIND/Cepheid (data by country and overall);
WHO (data by donor)
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
Xpert MTB/RIF cartridges procured under concessional prices
GLOBAL TB
PROGRAMME
Xp
ert
MTB
/RIF
car
trid
ges
2014 2013 2012 2011 2010 Data sources: FIND/Cepheid (data by country and overall);
WHO (data by donor)
0
200 000
400 000
600 000
800 000
1 000 000
1 200 000
1 400 000
Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Others (Global Fund, USAID, PEPFAR, MSF,etc.)India: USAID, 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)
USAID, PEPFAR, IPAQT, others
Xpert MTB/RIF cartridges procured under concessional prices
GLOBAL TB
PROGRAMME
0
500
1 000
1 500
2 000
2 500
3 000
3 500
4 000
Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2014 2013 2012 2011 2010
GeneXpert modules procured under concessional prices
Mo
du
les
GLOBAL TB
PROGRAMME
• 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
Background of the forecasting initiative
GLOBAL TB
PROGRAMME
• South Africa NHLS
• Global Fund
• UNDP
• TBXpert and EXPAND-TB projects/UNITAID
• USAID
• MSF
• GDF, including TB REACH
• Brazil NTP
• India NTP
Contributors to the initiative
GLOBAL TB
PROGRAMME
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
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