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  1. DRAFT USAID Portfolio Review: Tuberculosis January 14, 2011

  2. 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

  3. Tuberculosis epidemiology – incidence rates, 2009 Per 100,000 population • 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

  4. Estimated HIV prevalence in new TB cases, 2009 x x

  5. Absolute numbers of estimated cases with MDR-TB 0–9 10–99 100–999 1000–9 999 >10 000 No estimate • 25 high MDR-burden countries • ~ 55% in China + India + Russian Federation

  6. Rates per 100,000 population Global reductions in TB incidence, prevalence and mortality Much progress to date but targets not yet achieved Prevalence Incidence Mortality 300 35 140 200 Peak in 2004 25 100 100 15 target 60 target 0 1990 0 0 2015 1990 2009 1990 2015 Blue band = confidence interval

  7. The framework of the global Stop TB Strategy

  8. Scale of the Global Plan to Stop TB Planned budget 2011-2015 • Currently $21 billion funding gap to 2015 • USG investments in TB are critical to meeting these financing gaps

  9. 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

  10. USG funding for TB has increased steadily – recognizing both the seriousness of the challenge and USG successes in addressing it 545 478 • 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 454 378 298 CDC* 270 221 NIH 196 174 OGAC 143 USAID 96 88 76 67 * CDC data to come

  11. 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

  12. 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

  13. USG TB strategy: six key interventions that map to the GHI principles The six key TB interventions … … map to the 7 GHI principles • Focus on woman, girls, and gender equality (TB 5) • Encourage country ownership and invest in country-led plans (TB 1, 2) • Build sustainability through health systems strengthening (TB 1, 2, 4) • Strengthen and leverage key multilateral organizations, global health partnerships and private sector engagement (TB 1, 2, 5) • Increase impact through strategic coordination and integration (TB 1, 2, 3, 5) • Improve metrics, monitoring and evaluation (TB 1, 2, 4) • Promote research and innovation (TB 1, 2, 6) • Accelerate detection and treatment of TB • Scale-up prevention and treatment of MDR TB • Expand coverage of interventions for TB/HIV co-infection • Contribute to health system strengthening • Address social determinants of TB • Promote research and Innovation

  14. 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 • Lead for TB/HIV collaborative activities • Provides support for TB/HIV services under PEPFAR DoD OGAC • Lead for domestic TB within the U.S. • Contributes to international efforts led by the Stop TB partnership • Conducts operational and epidemiological research and training • Conducts programmatically relevant clinical and diagnostic studies. • Supports implementation in a number of countries • Supports laboratory networks CDC • 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 NIH • Addresses TB in military • Supports reference laboratory capacity

  15. Research – an example of coordination across the USG Basic science & discovery Pre-clinical trials Clinical trials phase 1-2 Clinical trials phases 2b-3 Field demonstration Policy & practice Operationsresearch, surveillance & evaluation Test and introduce new approaches CDC: Field preparedness for and implementation of trials NIH: Stimulating innovation USAID: Informing the research community on field priorities USAID: Bringing advances to the field

  16. USAID is currently working in 40 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 Underline = High TB burden countries; * MDR TB Countries

  17. Europe & Eurasia Region • 4USAID TB FTEs • 5 other project TB technical FTEs in country Regional* and HQ staffing for USAID’s TB portfolio** • Total USAID TB staffing footprint • 40 USAID TB FTEs • 40 other project TB technical FTEs in country Washington DC 11 HQ FTEs • Asia & Middle East • 6 USAID TB FTEs • 10 other project TB technical FTEs in country • Latin America/ Caribbean • 4USAID 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

  18. USAID’s strategic and operational level programming TB service delivery USAID TB expenditures in 2009 (% of total budget) Governance, finance, strategic information 11% • 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 Source: Foreign Assistance and Coordination Tracking System (FACTS)

  19. USAID funding is strategically allocated to help countries where they need it most Government, NTP budget, Loans Grants (excluding Global Fund) Global Fund • 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

  20. 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

  21. 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

  22. 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

  23. USAID TB Program – partners and activities at Headquarters Key partners and mechanisms Examples of activities and outputs Text • 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 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

  24. 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

  25. 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

  26. Key challenges the USAID TB program must address Topic Issue 1 2 Financial Programmatic • 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

  27. Financial challenge – uncertainty around funding 1 Budget scenario 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 Optimistic case Pessimistic 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 Base 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

  28. Financial challenge: gaps in Global Fund support Issue Planned response 1 • GFATM is a significant funding mechanism for TB program activity • Funding approved (through Round 9) in USG Priority Countries (historical) • Focus Countries $2.1 bn • 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 • 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)

  29. Programmatic challenges: capacity and cost constraints of managing MDR-TB 2 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 % treated of estimated cases of MDR-TB among all notified cases of TB Especially low in two regions with largest number of cases

  30. 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 Number of TB patients receiving testing and care for HIV in 20 USAID focus countries 2 % of TB patients 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

  31. Our approach to expediting scale-up of TB/HIV collaborative activities Planned response Issues 2 • 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 • 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

  32. Programmatic challenge: insufficient scale-up of new strategies Description/ goal Evidence for approach USAID engagement Mobilize communities • 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 2 • Philippines: private sector contributed 28% of new smear-positive cases detected in 2009 • Engage the private sector to improve quality TB controland increase case detection rates • Philippines: design and roll-out of innovative model to link private providers to national systems and insure national insurance reimbursement Engage the private sector

  33. Programmatic challenge: inadequate lab capacity Planned response Issues 2 • 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 • Outdated diagnostic tools • Inadequate infrastructure • Human resources lacking • Poor quality assurance • Too few labs

  34. Programmatic challenges: lack of optimum efficiency in use of new technologies Planned approaches Issues 2 • 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 • 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

  35. 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 2 US$ millions US$ millions All TB HIV+TB MDR-TB All TB HIV+TB MDR-TB

  36. 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! Wrap-up considerations