DRAFT
USAID Portfolio Review:
Tuberculosis
January 14, 2011
1
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
Tuberculosis epidemiology – incidence rates, 2009
Per 100,000 population
0–24
25–49
50–99
100–299
300 and higher
No estimate available
• 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
3
Estimated HIV prevalence in new TB cases, 2009
x
x
4
Absolute numbers of estimated cases with MDR-TB
0–9
0–9
10–99
10–99
100–999
100–999
11000–9
000–9 999
10
>10000
000and higher
No
Noestimate
estimateavailable
• 25 high MDR-burden countries
• ~ 55% in China + India + Russian Federation
5
Much progress to date but targets not yet achieved
Global reductions in TB incidence, prevalence and mortality
Rates per 100,000 population
Incidence
140
Prevalence
Peak in 2004
100
300
Mortality
60
0
1990
200
35
100
25
target
2009
15
0
1990
target
2015
0
1990
Blue band = confidence interval
2015
6
The framework of the global Stop TB Strategy
7
Scale of the Global Plan to Stop TB
Planned budget 2011-2015
Plan component
US$
billions
%
total
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%
IMPLEMENTATION
● Currently $21 billion
funding gap to 2015
● USG investments in TB
are critical to meeting
these financing gaps
8
Contents and executive summary
● Background
 Epidemiology – fighting disease in three groups: general population, HIV-affected, MDR-TB
 Fight against TB is well coordinated globally across a number of different actors, among
which USG plays a leading role
● USAID’s strategic approach
 USG context means important legal and policy requirements and a Whole of Gov’t
approach
 By area, > 90% of USAID resources spent on country-level activity
 By activity, 75% of funding supports service delivery, 11% M&E/HSS, 9% research
 Solid gains made in many areas, e.g., HIV patients tested for TB, but large numbers of
people still unreached
●
Challenges/areas of improvement and how we are working to resolve them
 Developing scenarios helps us work through funding uncertainties and constraints
 Working closely with Global Fund to address its constraints
 Scaling up priority areas of MDR-TB treatment, HIV/TB diagnosis and treatment, private
sector engagement and new technologies
● Wrap-up considerations
9
USG funding for TB has increased steadily – recognizing both the
seriousness of the challenge and USG successes in addressing it
600
545
Funding level ($, million)
500
400
CDC*
NIH
OGAC
USAID
478
454
378
298
300
270
221
200
100 67
143
76
88
174
196
96
● 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
0
* CDC data to come
10
USG targets embody important legal and policy frameworks
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
Global Health Initiative
• ~$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
11
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
The six key TB interventions …
… map to the 7 GHI principles
1. Accelerate detection and treatment of TB
1. Focus on woman, girls, and gender
equality (TB 5)
2. Scale-up prevention and treatment of MDR
TB
2. Encourage country ownership and invest
in country-led plans (TB 1, 2)
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
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
evaluation (TB 1, 2, 4)
and
7. Promote research and innovation (TB 1,
2, 6)
13
USAID works through a “Federal TB Task Force” to contribute to a
coordinated USG TB response
USAID
OGAC
CDC
NIH
DoD
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
Lead for TB/HIV collaborative activities
• Provides support for TB/HIV services under PEPFAR
Lead for domestic TB within the U.S.
• Contributes to international efforts led by the Stop TB partnership
o Conducts operational and epidemiological research and training
o Conducts programmatically relevant clinical and diagnostic studies.
o Supports implementation in a number of countries
o Supports laboratory networks
Lead 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
•
•
Addresses TB in military
Supports reference laboratory capacity
14
Research – an example of coordination across the USG
Basic science
& discovery
Preclinical
trials
Clinical
trials
phase 12
NIH: Stimulating innovation
USAID: Informing the research
community on field priorities
Clinical
trials
phases
2b-3
Field
demonst
ration
Test and
introduce
new
approaches
Operations
research,
surveillance
&
evaluation
Policy &
practice
CDC: Field preparedness for and
implementation of trials
USAID: Bringing advances to the field
15
USAID is currently working in 40 countries
Category
Countries
Focus
Afghanistan, Bangladesh*,
Countries Brazil, Cambodia, Democratic
(20)
Republic of Congo*, Ethiopia*,
India*, Indonesia*, Kenya,
Mozambique, Nigeria*,
Pakistan*, The Philippines*,
Russia*, South Africa*,
Tanzania, Uganda, Ukraine*,
Zambia, Zimbabwe
Other
Armenia*, Azerbaijan*, Bolivia,
Countries Djibouti, Dominican Republic,
(20)
Georgia*, Ghana, Haiti,
Kazakhstan*, Kyrgyzstan*,
Liberia, Malawi, Mexico,
Namibia, Peru, Senegal,
Southern Sudan, Tajikistan*,
Turkmenistan, Uzbekistan*
• 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
Underline = High TB burden countries; * MDR TB Countries
16
Regional* and HQ staffing for USAID’s TB portfolio**
Washington DC
11 HQ FTEs
Europe & Eurasia Region
• 4 USAID TB FTEs
• 5 other project TB technical FTEs in country
Total USAID TB
staffing footprint
• 40 USAID TB FTEs
• 40 other project TB
technical FTEs in
country
Latin America/
Caribbean
• 4 USAID TB FTEs
• 5 other project TB
technical FTEs in
country
Africa
• 16 USAID TB FTEs
• 20 project TB technical FTEs in
country
* Regional divisions per USAID’s operating model
** FTEs accurate as of 4 January 2011
Asia & Middle
East
• 6 USAID TB
FTEs
• 10 other project
TB technical
FTEs in country
17
USAID’s strategic and operational level programming
USAID TB expenditures in 2009
(% of total budget)
TB service
delivery
Governance, finance,
strategic information
11%
Research
9%
Program
support
5%
DOTS
expansion
29%
Care and
support
8%
MDR-TB
18%
TB-HIV
9%
● 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
TB Drugs
11%
Source: Foreign Assistance and Coordination Tracking System (FACTS)
18
USAID funding is strategically allocated to help countries
where they need it most
Government, NTP
budget, Loans
Russian Federation
Brazil
Grants (excluding
Global Fund)
South Africa
Ukraine
Global Fund
Philippines
India
Indonesia
• In low resource
Kenya
countries, USAID TB
programs support
policy dialogue,
technical assistance,
support for service
delivery and Global
Fund grant
implementation
Pakistan
Mozambique
Nigeria
Ethiopia
Afghanistan
United Republic of…
Zambia
Cambodia
• In higher resource
Uganda
Zimbabwe
Bangladesh
Democratic Republic…
0%
20%
40%
60%
80%
100%
countries we provide
the above but limited
support for service
delivery
% of total available funding
19
How we provide support – USAID has prioritized funding to the field
with targeted support from HQ
Provides for
• Response to gaps and local needs
• Partnership with Ministries of Health
• Collaboration with other donors and partners
• Global Drug Facility (directive)
Field level
>90% of total
funding
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
HQ/ regional bureaus < 10% of
total funding
20
USAID TB Program at the Country Level
How we work with countries
• Access to international technical expertise through global and countrylevel 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
Examples Text
of activities and outputs
• 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
•
•
•
•
•
•
•
•
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 XRay
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
Both detection and treatment in USAID Focus countries have
increased significantly
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*
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
* Source: WHO
24
Contents and executive summary
● Background
 Epidemiology – fighting disease in three groups: general population, HIV-affected, MDRTB
 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
25
Key challenges the USAID TB program must address
Topic
Issue
1 Financial
 Uncertainty around funding
 Gaps in Global Fund support
2 Programmatic
 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
26
1 Financial challenge – uncertainty around funding
Budget scenario
Optimistic case
Description
Response
Rationale
• Funding levels
• Maintain number of
• N/A
described in
GHI (~$2.2 bn
over 6 years)
• Funding
Base case
remains at
2010 levels,
with slow
growth
thereafter
• Funding
Pessimistic
case
returns to
2008 levels,
with slow
growth
thereafter
•
•
•
countries per original
projections
Continue research
Reduce priority countries up
to 5 by
‒ Accelerating graduation
‒ Discontinuing programs
not yet taken to scale
Delay entry into vaccine
research
• 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
• Focuses resources on
•
core activities and
countries
Preserves integrity of
continuing programs
• Programs protected as
•
•
•
•
per base case
Unlikely to achieve GHI
treatment targets
Lower case detection
rates
Less treatment success
Impact on MDR
27
1 Financial challenge: gaps in Global Fund support
Issue
Planned response
• GFATM is a significant funding
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)
mechanism for TB program activity
‒ Funding approved (through Round 9)
in USG Priority Countries (historical)
o Focus Countries $2.1 bn
o 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
28
2 Programmatic challenges: capacity and cost constraints of
managing MDR-TB
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
•
60
% treated of estimated cases of
MDR-TB among all notified cases
of TB
Especially low in two
40
regions with largest
28 number of cases
54
Percentage
50
40
30
Response
•
•
•
•
20
12
10
3
3
.P
ac
ifi
c
W
4
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
O
R
LD
si
a
W
S
E
A
R
E
M
pe
ro
ic
a
A
fr
E
u
A
m
er
i
ca
s
0
29
2 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
World
Number of TB patients receiving testing and
care for HIV in 20 USAID focus countries
USAID 40 countries
35
32
% of TB patients
30
26
25
26
24
22
20
20
15
15
11
9
10
5
45
12
34
0
2003 2004 2005 2006 2007 2008 2009
Real progress in TB patients
tested for HIV… but absolute
numbers still low
Testing for HIV improving … but
many TB/HIV patients don’t get
ARVs
30
2 Our approach to expediting scale-up of TB/HIV collaborative
activities
Planned response
Issues
• Few HIV/TB patients with access to
ARVs
• For PEPFAR Focus countries
– Review successful and
• 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
–
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
31
2 Programmatic challenge: insufficient scale-up of new
strategies
Mobilize
communities
Description/
goal
Evidence for approach
USAID engagement
• Mobilize
• Tanzania: reduced cost
• DRC community-based DOTS
• Philippines: 1840 treatment
CHWs to
increase
detection and
treatment
rates while
decreasing
costs
•
Engage the
private sector
Engage the
private
sector to
improve
quality TB
control and
increase
case
detection
rates
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
•
•
•
Philippines: private
sector contributed
28% of new smearpositive cases
detected in 2009
•
•
•
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
• Philippines: design and roll-out of
innovative model to link private
providers to national systems and
insure national insurance
reimbursement
2 Programmatic challenge: inadequate lab capacity
Planned response
Issues
• Outdated diagnostic tools
• Inadequate infrastructure
• Human resources lacking
• National strategic planning for labs
and networks
• Enhance support to Global Laboratory
Initiative for country planning and
monitoring (USAID and PEPFAR)
• Poor quality assurance
• Accreditation and QA systems
• Too few labs
• Build evidence base / policies for most
efficient use of new technologies
• Support roll-out of new technologies
33
2 Programmatic challenges: lack of optimum efficiency in use of
new technologies
Planned approaches
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
•
•
•
•
•
Determine the right pace of scale-up of
a shorter, more expensive TB
treatment regimen
Determine cost-effectiveness and
strategic value of investments in latestage 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
34
2 Programmatic challenges: lack of optimum efficiency in use of
new technologies – example of “Xpert”
•
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
South Africa
US$ millions
US$ millions
40
Russia
20
0
All TB
HIV+TB
Xpert
MDR-TB
Without Xpert
5
0
All TB
HIV+TB
Xpert
MDR-TB
Without Xpert
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