unified xpert mtb/rif forecasting initiative - who.int · sa nasal complete c. diff (us only) c....

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


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


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


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


GLOBAL TB

PROGRAMME

0

500

1 000

1 500

2 000

2 500

3 000

3 500

4 000


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

GLOBAL TB

PROGRAMME

Thank you Wayne van Gemert WHO Global TB Programme [email protected]

unified xpert mtb/rif forecasting initiative - who.int · sa nasal complete c. diff (us only) c....

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