USAID Portfolio Review: Tuberculosis

January 14, 20111

DRAFT

Contents and executive summary

● Background- Epidemiology – fighting disease in three groups: general population,

HIV-affected, MDR-TB- Fight against TB is well coordinated globally across a number of

different actors, among which USG plays a leading role

● USAID’s strategic approach- USG context means important legal and policy requirements and a Whole of

Gov’t approach - By area, > 90% of USAID resources spent on country-level activity- By activity, 75% of funding supports service delivery, 11% M&E/HSS, 9%

research- Solid gains made in many areas e.g. HIV patients tested for TB but large

numbers of people still unreached

● Challenges/areas of improvement and how we are working to resolve them- Scenarios help us work through funding uncertainties and constraints- Working closely with Global Fund to address its constraints- Scaling up priority areas of MDR-TB treatment, HIV/TB diagnosis and treatment,

private sector engagement and new technologies

● Wrap-up considerations

2

0–24

25–49

50–99

100–299

300 and higher

No estimate available

Tuberculosis epidemiology – incidence rates, 2009

• 9.4 million cases, 1.7 million deaths annually • 22 countries account for 80% of global burden• Primarily affects most economically

productive age group (18-40)• Social determinants linked to poverty• Gender variation in epidemiology across

countries

Per 100,000 population

3

Estimated HIV prevalence in new TB cases, 2009

4

x

x

0–9

10–99

100–999

1 000–9 999

10 000 and higher

No estimate available

0–9

10–99

100–999

1000–9 999

>10 000

No estimate

Absolute numbers of estimated cases with MDR-TB

• 25 high MDR-burden countries• ~ 55% in China + India + Russian Federation

5

Global reductions in TB incidence, prevalence and mortalityRates per 100,000 population

2015

Mortality

1990

35

25

15

0

target

Prevalence

1990

300

200

100

0

2015

target

Much progress to date but targets not yet achieved

Incidence

140

100

60

0

Peak in 2004

1990 2009

Blue band = confidence interval 6

The framework of the global Stop TB Strategy

7

Scale of the Global Plan to Stop TB

Plan component US$ billions

% total

IMPLEMENTATION 36.9 79%

DOTS 22.6 48%

MDR-TB 7.1 15%

TB/HIV 2.8 6%

Lab strengthening 4.0 8%

TA 0.4 1%

R&D 9.8 21%

TOTAL 46.7 100%

Planned budget 2011-2015

● Currently $21 billion funding gap to 2015

● USG investments in TB are critical to meeting these financing gaps

8

Contents and executive summary

9

● Background- Epidemiology – fighting disease in three groups: general population, HIV-

affected, MDR-TB- Fight against TB is well coordinated globally across a number of different actors,

among which USG plays a leading role

● USAID’s strategic approach- USG context means important legal and policy requirements and a

Whole of Gov’t approach - By area, > 90% of USAID resources spent on country-level activity- By activity, 75% of funding supports service delivery, 11% M&E/HSS,

9% research- Solid gains made in many areas, e.g., HIV patients tested for TB, but

large numbers of people still unreached

● Challenges/areas of improvement and how we are working to resolve them- Developing scenarios helps us work through funding uncertainties and

constraints- Working closely with Global Fund to address its constraints- Scaling up priority areas of MDR-TB treatment, HIV/TB diagnosis and treatment,

private sector engagement and new technologies

● Wrap-up considerations

USG funding for TB has increased steadily – recognizing both the seriousness of the challenge and USG successes in addressing it

pre-1

9981998

19992000

20012002

20032004

20052006

20072008

20092010

0

100

200

300

400

500

600

Fu

nd

ing

level ($

, m

illion

)

67 76 88 96

143174

196

221

270298

378

454478

545

USAID

NIHCDC*

OGAC● USG present in

TB research for many years, but extensive experience in implementation only over the last few years

● Moment is right to take stock of results, lessons learned, gaps

10* CDC data to come

• ~$2.2 billion over 6 years for TB in original estimate• Successfully treat at least 2.6 million new TB cases• Diagnose and initiate treatment for at least 57,200 MDR

TB cases

Global Health Initiative

USG targets embody important legal and policy frameworks

11

Millennium Development Goals/ Stop TB

• 50% reduction in TB deaths vs. 1990• 50% reduction in TB disease burden vs. 1990 • Detect at least 70% of sputum positive cases by 2015• Treat at least 85% of cases detected by 2015

Lantos-Hyde PEPFAR Reauthorization 2009-2013

• $4 billion over 5 years for TB• Successfully treat 4.5 million new sputum positive patients

under DOTS• Diagnose and treat 90,000 new multi-drug resistant TB

cases

Key approaches for the USG TB strategy

Promote country ownership

Identify and directly target constraints to progress

Address key financing gaps and serve as funding catalyst

Leverage resources Promote success of Global Fund grants Further TB/HIV through PEPFAR Capitalize on other health platforms

(nutrition, MCH, etc.)

Provide global technical leadership

Invest in the future – new tools and innovation

Expand partnerships Stop TB, UNITAID, Global Fund

12

USG TB strategy: six key interventions that map to the GHI principles

1. Accelerate detection and treatment of TB

2. Scale-up prevention and treatment of MDR TB

3. Expand coverage of interventions for TB/HIV co-infection

4. Contribute to health system strengthening

5. Address social determinants of TB

6. Promote research and Innovation

13

1. Focus on woman, girls, and gender equality (TB 5)

2. Encourage country ownership and invest in country-led plans (TB 1, 2)

3. Build sustainability through health systems strengthening (TB 1, 2, 4)

4. Strengthen and leverage key multilateral organizations, global health partnerships and private sector engagement (TB 1, 2, 5)

5. Increase impact through strategic coordination and integration (TB 1, 2, 3, 5)

6. Improve metrics, monitoring and evaluation (TB 1, 2, 4)

7. Promote research and innovation (TB 1, 2, 6)

… map to the 7 GHI principles

The six key TB interventions …

USAID works through a “Federal TB Task Force” to contribute to a coordinated USG TB response

Lead for international TB control• Supports implementation and scale up of STOP TB Strategy in 40

countries, through national TB Programs and private sector• Drives international policy development• Supports operational research and late-stage clinical trials

USAID

OGACLead for TB/HIV collaborative activities• Provides support for TB/HIV services under PEPFAR

CDCLead for domestic TB within the U.S.• Contributes to international efforts led by the Stop TB partnership

o Conducts operational and epidemiological research and trainingo Conducts programmatically relevant clinical and diagnostic

studies. o Supports implementation in a number of countrieso Supports laboratory networks

NIHLead for research in TB• Supports basic science research, pre-clinical development and

clinical evaluation of drugs, diagnostics and vaccines• Supports research training, infrastructure and capacity building

DoD• Addresses TB in military• Supports reference laboratory capacity

14

Pre-clinical trials

Research – an example of coordination across the USG

USAID: Bringing advances to the field

CDC: Field preparedness for and implementation of trialsNIH: Stimulating innovation

USAID: Informing the research community on field priorities

15

Basic science & discovery

Clinical trials phase

1-2

Clinical trials

phases 2b-3

Field demonstration

Policy & practice

Operations research, surveillance & evaluation

Test and introduce new approaches

USAID is currently working in 40 countries

16

Category

Countries

Focus Countries (20)

Afghanistan, Bangladesh*, Brazil, Cambodia, Democratic Republic of Congo*, Ethiopia*, India*, Indonesia*, Kenya, Mozambique, Nigeria*, Pakistan*, The Philippines*, Russia*, South Africa*, Tanzania, Uganda, Ukraine*, Zambia, Zimbabwe

Other Countries (20)

Armenia*, Azerbaijan*, Bolivia, Djibouti, Dominican Republic, Georgia*, Ghana, Haiti, Kazakhstan*, Kyrgyzstan*, Liberia, Malawi, Mexico, Namibia, Peru, Senegal, Southern Sudan, Tajikistan*, Turkmenistan, Uzbekistan*

Underline = High TB burden countries; * MDR TB Countries

• Countries of greatest need as defined by: – TB burden– TB incidence– HIV/AIDS prevalence – Prevalence or

potential for MDR-TB or XDR-TB

– Lagging case detection and treatment success rates

• Additionally, the portfolio includes countries based on– Technical &

managerial feasibility– Political commitment

Regional* and HQ staffing for USAID’s TB portfolio**

17

Washington DC11 HQ FTEs

Africa• 16 USAID TB FTEs• 20 project TB technical FTEs in

country

Asia & Middle East• 6 USAID TB

FTEs• 10 other

project TB technical FTEs in country

Latin America/ Caribbean• 4 USAID TB FTEs• 5 other project TB

technical FTEs in country

Europe & Eurasia Region• 4 USAID TB FTEs• 5 other project TB technical FTEs in country

* Regional divisions per USAID’s operating model** FTEs accurate as of 4 January 2011

Total USAID TB

staffing footprint

• 40 USAID TB FTEs

• 40 other project TB

technical FTEs in

country

DOTS ex-pansion

28%

MDR-TB18%

TB Drugs11%

TB-HIV9%

Care and support8%

Pro-gram sup-port 5%

Re-search

9%

TB service delivery

USAID’s strategic and operational level programming

● Almost 75% of funding spent on TB service delivery

● Resource allocations made to address particular country strategies and needs

● Large scale-up over recent years in MDR-TB reflects strategic priorities

USAID TB expenditures in 2009 (% of total budget)

Source: Foreign Assistance and Coordination Tracking System (FACTS)

Governance, finance, strategic information

11%

18

Democratic Republic of the Congo

Bangladesh

Zimbabwe

Uganda

Cambodia

Zambia

United Republic of Tanzania

Afghanistan

Ethiopia

Nigeria

Mozambique

Pakistan

Kenya

Indonesia

India

Philippines

Ukraine

South Africa

Brazil

Russian Federation

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

% of total available funding

USAID funding is strategically allocated to help countries where they need it most

19

• In low resource countries, USAID TB programs support policy dialogue, technical assistance, support for service delivery and Global Fund grant implementation

• In higher resource countries we provide the above but limited support for service delivery

Government, NTP budget, Loans

Grants (excluding Global Fund)

Global Fund

Provides for• Response to gaps and local needs• Partnership with Ministries of Health• Collaboration with other donors and

partners• Global Drug Facility (directive)

Provides for • Policy development and activities of global /

regional benefit• Research with global implications• Technical support to the field for evaluation,

program design, monitoring, special issues

Field level

>90% of total funding

HQ/ regional bureaus < 10% of total funding

How we provide support – USAID has prioritized funding to the field with targeted support from HQ

20

USAID TB Program at the Country Level

How we work with countries• Access to international technical expertise through global and

country-level projects• Quality-assured laboratories• Standardized treatment, patient support and supervision• Quality drug supply management system• M&E• TB-HIV• MDR• Community care• Partnership with the private sector• Support for the Global Fund and other partners

Indonesia country example – responding to country priorities and constraints

TB program support – mainly Government of Indonesia (GOI), GF, and USAID

• Some USAID-funded staff co-located with National TB Program

• Priorities for Ministry translated into USAID funding priorities Promoting success of Global Fund resources Launching MDR-TB diagnosis, treatment

Ensuring quality TB diagnosis and treatment in hospitals and prisons

• Results: National case detection increased from 39% (2002) to 80% (2008)

USAID able to swiftly reprogram funds to cover critical funding needs when GF grant stalled (2009)/joint work plan with GF and GOI

By end of 2010, 162 MDR-TB patients put on treatment with USAID support Pilot hospitals doubled case detection from 2007 to 2009

• Expansion to 169 hospitals• Referral networks to 65 district health offices

• Work began in prisons

22

USAID TB Program – partners and activities at Headquarters

Key partners and mechanisms• WHO: technical leadership,

normative functions and technical assistance

• CDC: operational research, infection control, MDR surveillance, laboratory activities

• TREAT TB: research

• Strengthening Pharmaceutical Systems, U.S. Pharmacopeia: supply chain management, drug quality assurance project

• Stop TB Partnership, including GDF

• TB CARE I and II, TB Task Order: projects that implement STOP TB Strategy

Text

• International Standards of TB Care• Lab Toolbox• Planning and Budgeting Tool• Public-Private Mix Toolkit• Electronic TB Register• Guide for Quality Diagnosis and Role of

X-Ray • Patient-Centered Approach Package• Guiding Principles and Practical Steps

For Engaging Hospitals in TB Care and Control

• Guideline for Control of TB in Prisons• TB Infection Control Framework• Research e.g. introduce new

diagnostics, new tools and transmission, shortened regimen for MDR TB, Phase IIb drug trials

• Global TB Report• Development of regional institutions for

TB training and human resource development

• Enhanced availability of quality drugs

Examples of activities and outputs

Both detection and treatment in USAID Focus countries have increased significantly

* Source: WHO 24

USAID’s approach to fighting TB• Invest substantially in country and global routine systems of data collection and analysis• Support country ownership• Measure success by country-level progress

*

Trend in new smear-positive cases detected and case detection rates in USAID’s Focus countries*

Trend in new smear-positive cases successfully treated and treatment success rates in USAID’s Focus countries*

Contents and executive summary

25

● Background- Epidemiology – fighting disease in three groups: general population, HIV-

affected, MDR-TB- Fight against TB is well coordinated globally across a number of different

actors, among which USG plays a leading role

● USAID’s strategic approach- USG context means important legal and policy requirements and a Whole of

Gov’t approach - By area, > 90% of USAID resources spent on country-level activity- By activity, 75% of funding supports service delivery, 11% M&E/HSS, 9%

research- Solid gains made in many areas, e.g., HIV patients tested for TB, but large

numbers of people still unreached

● Challenges/areas of improvement and how we are working to resolve them- Developing scenarios helps us work through funding uncertainties

and constraints- Working closely with Global Fund to address its constraints- Scaling up priority areas of MDR-TB treatment, HIV/TB diagnosis

and treatment, private sector engagement and new technologies

● Wrap-up considerations

Key challenges the USAID TB program must address

Financial

Programmatic

1

2

26

Uncertainty around funding Gaps in Global Fund support

Capacity and cost constraints of managing MDR-TB

Slow uptake of proven interventions for TB/HIV and other new service delivery and diagnostic approaches

Insufficient scale-up of new strategies

Inadequate lab capacity Lack of optimum efficiency in

scale-up of new technologies

IssueTopic

Financial challenge – uncertainty around funding1

Description Response Rationale

• Funding levels described in GHI (~$2.2 bn over 6 years)

• Maintain number of countries per original projections

• Continue research

• N/A

Budget scenario

Optimistic case

Base case• Funding

remains at 2010 levels, with slow growth thereafter

• Reduce priority countries up to 5 by

‒ Accelerating graduation

‒ Discontinuing programs not yet taken to scale

• Delay entry into vaccine research

• Focuses resources on core activities and countries

• Preserves integrity of continuing programs

27

Pessimistic case

• Funding returns to 2008 levels, with slow growth thereafter

• Reduce priority countries up to 9

• Reduce role in late-stage research

• Propose reduction to Global Drug Facility (legislated)

• Reduce involvement in Stop TB Partnership

• Programs protected as per base case

• Unlikely to achieve GHI treatment targets

• Lower case detection rates

• Less treatment success

• Impact on MDR

Issue

• GFATM is a significant funding mechanism for TB program activity‒ Funding approved (through Round

9) in USG Priority Countries (historical)o Focus Countries $2.1 bno Other Countries: $5.2 bn

• GFATM needs help in addressing funding challenges‒ Delays in grant signing ‒ Suspension of funds, requiring

USAID response to maintain core activities

‒ Lack of reprogramming‒ Lack of transparency‒ Drug stock-outs

Planned response

Set up GFATM for success• Use our access and voice within

GFATM to improve performance:‒ USG delegation on the GF Board‒ Technical Review Panel for the GF‒ GF CCM or sub committees at the

country level• Use policy dialogue to shape

provision of TA to countries to accelerate grant signing (currently against GF policy)

• Target support and TA to develop grants, improve grant performance and remove grant bottlenecks

• Strengthen “TB TEAM” housed in WHO to proactively prevent bottlenecks (rather than response)

Financial challenge: gaps in Global Fund support 1

28

Programmatic challenges: capacity and cost constraints of managing MDR-TB

54

40

28

4 3 3

12

0

10

20

30

40

50

60

Percen

tag

e

% treated of estimated cases of MDR-TB among all notified cases of TB

Especially low in two regions with largest number of cases

2

29

Response

• Transition from project to program-based MDR-TB management

• Employ system-based approach consistent with USAID overall strength and experience

• Extend treatment beyond facility to community

• Help expand drug manufacturing capacity

Issue

• Diagnosis of MDR TB will outpace capacity to treat, e.g., drug manufacturing capacity

• Capacity to manage/ensure the quality of rapid scale-up of MDR-TB treatment not yet clear

Programmatic challenge: quick uptake of proven interventions for TB/HIV but with room to grow

Proportion of TB patients tested for HIV in 40 USAID countries vs. world

2003 2004 2005 2006 2007 2008 20090

5

10

15

20

25

30

35

43

9

12

2022

26

4.5 3.7

11

15

2426

32

World USAID 40 countries

Real progress in TB patients tested for HIV…

but absolute numbers still low

2

30

% o

f TB

pati

ents

Number of TB patients receiving testing and care for HIV in 20 USAID focus countries

Testing for HIV improving … but many TB/HIV

patients don’t get ARVs

Issues

• Few HIV/TB patients with access to ARVs

• TB/HIV collaborative activities not standard of care in all priority countries

• Limited uptake of TB issues by HIV community

• Result is slow uptake of three I’s‒ Infection control‒ Isoniazid preventive therapy‒ Intensified case finding

Planned response

• For PEPFAR Focus countries

– Review successful and unsuccessful models of TB/HIV collaborative activities for lessons learned

– Apply these lessons in national scale up modeled on successful programs

– Increase country accountability for meeting TB/HIV targets

• For non-focus PEPFAR countries, increase resources for TB/HIV needed to enable scale-up

Our approach to expediting scale-up of TB/HIV collaborative activities

2

31

Programmatic challenge: insufficient scale-up of new strategies

2

Mobilize communities

Description/ goal

Evidence for approach USAID engagement

• Mobilize CHWs to increase detection and treatment rates while decreasing costs

• Tanzania: reduced cost by 35% (27% for health services, 72% for patients)

• Uganda: treatment success rates from 56% to 74%, costs halved

• Ethiopia: health extension workers manage a case for 39% of what it costs by general health workers

• DRC community-based DOTS • Philippines: 1840 treatment

partners involved• Nigeria: community

volunteers referred almost 5000 people for TB diagnosis

• Ethiopia: 1105 community extension workers engaged

• Mozambique: community volunteers referred almost 19,000 people for TB diagnosis

Engage the private sector

• Engage the private sector to improve quality TB control and increase case detection rates

• Philippines: private sector contributed 28% of new smear-positive cases detected in 2009

• Philippines: design and roll-out of innovative model to link private providers to national systems and insure national insurance reimbursement

Planned response

• National strategic planning for labs and networks

• Enhance support to Global Laboratory Initiative for country planning and monitoring (USAID and PEPFAR)

• Accreditation and QA systems

• Build evidence base / policies for most efficient use of new technologies

• Support roll-out of new technologies

Programmatic challenge: inadequate lab capacity2

33

Issues

• Outdated diagnostic tools

• Inadequate infrastructure

• Human resources lacking

• Poor quality assurance

• Too few labs

Planned approaches

• Determine the right pace of scale-up of a shorter, more expensive TB treatment regimen

• Determine cost-effectiveness and strategic value of investments in late-stage drug trials

• Consider whether USAID funds should leverage Global Fund and PEPFAR procurement of commodities and technology

• Study how best to support evidence generation for programmatic use of tools, in combination

• Determine if there is a role for USAID in TB vaccine development

Programmatic challenges: lack of optimum efficiency in use of new technologies

2

34

Issues

• How best to use new tools and technologies e.g.

• New drugs‒ Shortened regimen (4

months) will cost more, uptake uncertain

‒ New drugs for MDR• New diagnostics newly

endorsed by WHO but limited programmatic experience

• Vaccine development• Prioritization and sequencing of

implementation

0

20

40South Africa

Xpert Without Xpert

0

5Russia

Xpert Without Xpert

All TB HIV+TB MDR-TB All TB HIV+TB MDR-TB

• Transformative new diagnostic technology which allows rapid diagnosis at district and sub-district levels

• Programmatic challenges– Cost– Appropriateness (need stable electricity source)– Security issues (comes with a laptop)– Requires revised diagnostic algorithms

US

$ m

illi

ons

US

$ m

illi

ons

Programmatic challenges: lack of optimum efficiency in use of new technologies – example of “Xpert”

2

Wrap-up considerations

• USG role is critical and growing• Countries in driver’s seat, taking more ownership• Donors more coordinated but with lighter architecture

• Key questions for discussion– Given funding constraints and our discussion of relative priorities, what

aspects of the portfolio should be scaled back in the Base and Pessimistic funding scenarios?

– Is there more that the USG/USAID can do to ensure the success of Global Fund grants?

– What should be our role in scaling up new diagnostic tools such as Xpert, new drugs and new treatment regimens such as short course treatment for MDR-TB?

• Next steps– Adjust programs to reflect FY 2011 and out-year funding situation– Follow up on today’s discussion and recommendations– Work with you and other key partners on these challenges through the

Federal TB Task Force

THANK YOU!36