Presentation to the Institute of Medicine Outcome and Impact Evaluation Committee February 22, 2011

Transcription

1 PEPFAR Moving Forward: Shared Responsibility, Smart Investments, Promoting Security, Saving Lives Presentation to the Institute of Medicine Outcome and Impact Evaluation Committee February 22, 2011

2 PEPFAR: A Status Report 2003 PEPFARLaunched 2008 PEPFAR Reauthorized through Counseling and testing for nearly 33 million people Support and care for over 11.3 million people, including nearly 3.8 million orphans and vulnerable children Over 600,000 pregnant women receive PMTCT, over 114,000 babies of HIV+ mothers born HIV-free Over 3.2 million people on antiretroviral treatment

3 3,500,000 PEPFAR Saving Lives Number of People Directly Supported on Treatment by PEPFAR ( ) 3,209,900 People on Treatment 3,000,000 2,500,000 2,000,000 1,500,000 1,000, , ,485,300 1,743,600 1,091, ,300 67, , Year

4 PEPFAR Moving Forward We have a shared responsibility to make and effectively implement smart investments that promote security and save lives. Building on PEPFAR s Success Accelerating the Prevention of Motherto-Child Transmission Savings in Antiretroviral Drugs Service Delivery Efficiency Male Circumcision Strengthening Multilateral Partnerships US Global Health Initiative

5 Smart Investments for Impact and Efficiency: 7 Areas of Focus Strengthening use of economic and financial data to ensure efficient use of resources. Incorporating innovations that promote efficiency and allocating resources based on impact. Increasing collaboration with governments, the Global Fund and other stakeholders to align programs and target investments. Reducing costs by streamlining our U.S. Government operations and supporting increased country ownership. Achieving the best available, all-inclusive commodity pricing. Leveraging creative mechanisms for healthcare financing, in order to bring additional resources to bear. Developing an evaluation and research agenda that will show all global health programs how to improve efficiency and impact.

6 Saving Children, Mothers and Families: Accelerating Prevention of Mother-to-Child Transmission OGAC leading intensified interagency effort that leverages strengths of CDC, USAID, others PEPFAR Commitment: 80% coverage of testing at the national level, and 85% coverage of prophylaxis/treatment for infected pregnant women, by 2014 Additional $100 million in to support 6 countries in accelerating expansion of HIV testing and antiretroviral prophylaxis Additional $100 million planned in 2011 Investments are linked with maternal and child health, family planning, and nutrition as a part of wider efforts to support comprehensive services under the Global Health Initiative

7 PEPFAR Delivery of PMTCT PMTCT services must operate at all levels of the healthcare system to be successful: Community: Education/demand generation for services, HIV testing, peer support Antenatal Care Clinics: Education, HIV testing, ARVs and follow-up Labor and delivery services: HIV testing, ARVs for mothers/babies Maternal, newborn and child health (MNCH) settings: ARVs, breastfeeding education, early infant testing, pediatric care and treatment Antiretroviral treatment sites PEPFAR s programs look somewhat different in every country, but are delivering remarkable results PEPFAR counseled and tested 8.3 million women for HIV in 2010 PEPFAR provided ARV prophylaxis or treatment to 600,000 HIV infected women in 2010

8 Moving to Better PMTCT Regimens Source: 2010 UA report

9 Gender of Adults Receiving PEPFAR-supported ART in 2010

10 Country Progress Toward PMTCT ARV Coverage Start-up / struggling countries(<50% ARV coverage) Nigeria Ethiopia Vietnam Cote D'Ivoire Haiti Mozambique Scale-up Countries (50-80% ARV coverage) Tanzania Kenya Namibia Uganda Approaching Virtual Elim. (>80% ARV prophylaxis) Zambia Rwanda South Africa Guyana Botswana 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

11 PEPFAR PMTCT Acceleration Plans To meet these goals, PEPFAR challenged select country teams to write PEPFAR PMTCT acceleration Plans in 2010 Chosen for coverage rates, large numbers of infections, poor quality of linkages, yet signs of progress Worked with governments to use data and programmatic knowledge to develop rapidly implementable plans to improve coverage and quality of PMTCT services $100 million allocated to 6 countries with large numbers new infant infections to implement PMTCT Acceleration Plans in 2010 Required 10% of funding to be used for monitoring and evaluation of programs

12 Unmet Need for PMTCT: The Example of Nigeria Since 2000, prevalence among adults has stabilized at under 4%, as compared to an approximate prevalence of 4.6% among pregnant women Young women between the ages of 15 and 24 are more than twice as likely to be living with HIV as young men in the same age range In 2008, only 58% of pregnant women received antenatal care and 39% were assisted by skilled birth attendants at delivery 13% of pregnant women were tested for HIV in 2009 and 22% of pregnant HIV-infected women received ARVs to prevent transmission

13 PEPFAR Nigeria PMTCT Acceleration Plan Plans for increasing ARV coverage to 50% of pregnant HIVinfected women by end of 2011 (combining resources from GON, PEPFAR and Global Fund). Funded a plan that targets known bottlenecks and will: Improve knowledge about HIV prevention and increase community demand for PMTCT services Provide resources and training to allow rural primary healthcare clinics to provide PMTCT Appoint lead implementing partners responsible for assisting each of 36 states to coordinate resources and implement strategies

14 PEPFAR Moving Forward on PMTCT (1) Based on encouraging early results of additional 2010 funding, PEPFAR plans to provide $100 million additional PMTCT funding in 2011 PEPFAR is coordinating with all U.S. global health programs to integrate PMTCT and HIV prevention, care and treatment services to reach more women, children and families PEPFAR is pursuing innovations in early infant diagnosis, point of care testing

15 PEPFAR Moving Forward on PMTCT (2) Working with the Global Fund in country to optimize the effectiveness of all investments in PMTCT with coordination, planning, monitoring Providing technical support to World Health Organization to assist countries with adoption of new PMTCT guidelines Partnering with countries, communities, organizations to support development and implementation of strong country plans to end pediatric AIDS PMTCT is smart prevention effective and achievable saving the lives of mothers, supporting families, and allowing babies to be born HIV-free

16 ARVs: Trend Toward Reliance on Generics * 88% Generic 89% Generic 73% Generic 40% Generic 16% Generic * pack volume decrease d in 2009 due in part to increased purchasing of fixed dose combinations

17 Savings from Purchase of Generic ARVs In the five years to September 2010, working with PEPFAR implementers, SCMS has maximized the purchase of generic ARVs rather than innovator products Over the life of the project the cost of SCMS purchased generic ARVs is around US$700M lower than the estimated cost of similar innovator products at Accelerated Access Initiative (AAI) prices

18 Regimen Cost per Patient Year for Tenofovir(TDF), Lamivudine(3TC) and Efavirenz(EFV) $473 singles TDF + 3TC + EFV Lowest Originator: $ 505 $159 singles $155 FDCs # of tfda approved generic suppliers of TDF 300mg Note: Originator TDF 300mg until Nov 2007 when first generic tfda approved 18

19 Applying Commercial Best Practice for Africa Eliminates Stock-Outs and Reduces Cost Regional Distribution Centers Ghana, Kenya, South Africa Making critical ARV drugs available for emergency needs Increasing availability of product and reduce the lead time Reducing logistics costs focus on landed cost for all recipients 19

20 International transport % by mode

21 Future Savings in Antiretroviral Drugs Increases in pooled procurement (currently at 50% within PEPFAR) Both PEPFAR and the Global Fund increasingly pool orders through SCMS, a non-profit consortium Movement from air freight to land and sea freight New antiretroviral drugs with lower active pharmaceutical ingredient dosages (rilpivirine) Dose reductions of approved antiretroviral drugs New formulations (atazanavir/heat stable ritonavir co- -formulation) Process chemistry innovations (efavirenz)

22 29.1M men to be circumcised across all 14 countries Male Circumcision: Goals & Cost Around US$1B needed across all 14 countries for the 5 year catch-up period

23 Male Circumcision: Impact Country Potential Impact of 80% coverage of Male Circumcision (2009 through 2025) Male Circumcisions (millions) Male Circumcisions to avert 1 HIV infection HIV infections averted Botswana ,000 Ethiopia (Gambella) Kenya (Nyanza) ,000 Lesotho 0.8 <10 121,000 Malawi ,000 Mozambique ,000 Namibia ,000 Rwanda ,000 South Africa ,406,000 Swaziland 0.5 <10 64,000 Tanzania ,000 Uganda ,000 Zambia ,000 Zimbabwe 5.8 <10 833,000 4,211,000

24 Infections Averted with Medical Male Circumcision: Number and Percentage Reductions, by Country Number of HIV infections averted 1,400,000 1,200,000 1,000, , , , ,000 Cumulative number and percentage of HIV infections averted between by scaling up male circumcision 0 23% 17% 18% 36% 28% 13% 22% 28% 19% 33% 9% 25% 28% 42% 22% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% Percent of Infections averted by MC

25 Male Circumcision: Potential Savings Estimated five-year cost to reach 80% MC coverage: $1 billion Estimated cumulative savings: $20.3 billion

26 Multilateral Partnerships US announced a historic $4 billion pledge over 3 years to the Global Fund PEPFAR and the Global Fund are the two largest sources of HIV spending worldwide A 38% increase over past commitments In addition to $5.1 billion provided to date A call to action for increased collaboration to improve grant management and implementation Ensure that every dollar s impact is maximized to save lives

27 The US Global Health Initiative A commitment by President Obama to help partner countries improve health outcomes Opportunity to leverage the foundation of PEPFAR to expand services, including treatment and prevention of infectious diseases, maternal and child health services, clean water, and more Exercise in integration

28 Progress Toward Country Ownership PEPFAR Partnership Frameworks Document mutual commitments for five years, promoting mutual Document mutual commitments for five years, promoting mutual accountability in areas such as financing and policy reform 21 signed to date, with more to follow Entered into with governments, with involvement of civil society Regional Frameworks now in place for Caribbean and Central America To support alignment with national planning processes, PEPFAR is also increasing country-level coordination with Global Fund 6-10 joint pilot planning countries under consideration

29 PEPFAR Programs and Health Needs

30 PEPFAR Programs and Health Needs

31 A Shared Global Responsibility In 2009, the US accounted for almost 60% of commitments by donor governments

32 Leading the Effort to Save Lives Emergency Response Building Sustainability Fostering Country Ownership Engaging Civil Society Self-Sustaining Sustaining Response

33 Overview: PEPFAR-Funded Evaluations

34 Current PHE Studies 92 PHEs Single Country Multi-Country Approved / Ongoing In Protocol Development Approved / Ongoing In Protocol Development

35 PHE Study Topics Care and Treatment (45) HIV/TB HSS/HRH Costing PMTCT / Pediatrics (23) OVC Sexual Transmissions/Prevention (19) Male Circumcision Counseling and Testing (5) Total PHEs: 92 (includes multi-country PHEs)

36 PHE Implementation Challenges Many concepts not approved after technical review Unclear methodologies, sample size and statistical power issues Slow progress on many studies Transition from concept to protocol is problematic Protocol review often takes multiple iterations Multi-country studies slowed by many moving parts Long delays result in irrelevance of original concept Country Teams are reluctant to engage in PHE process Ensuring the appropriate balance between quality PHE and timeliness of execution

37 Transitioning PHE Reframe in context of Implementation Science Align directly with each country s national research priorities With country government, develop a national HIV/AIDS research-needs assessment and plan, a plan for researchcapacity building, and a plan for utilizing research to better inform policies and programs Capacity building necessary to enable in-country investigators and institutions to lead studies

38 ImplementationScience From: Padian, Holmes, McCoy, Lyerla, Bouey and Goosby: JAIDS, 2011

39 What is Implementation Science? Methods to improve the uptake, implementation, and translation of researchfindingsintoroutineandcommonpractices. Less focus on what works and more on how we : Deliver interventions efficiently and effectively Transfer and adapt interventions from one setting or population to another Make informed, evidence-based choices between competing: interventions components within a combination strategy strategies for delivery

40 Overall Goals of an IS agenda Choosing interventions strategically Focusing them where they will have maximum benefit Improve implementation efficiency Better management Strategic integration with other services Maximize long-term benefit, not results for the annual report

41 What Does IS Mean for PEPFAR? Provides a single framework for the entire spectrum of PEPFAR programs and evaluations from M & E OR IE Provides a uniform strategy for the collection and use of information across the entire IS spectrum Strengthens standards of evidence that underlie PEPFAR activities Focuses resources on critical questions and casual evidence

42 IS Capacity Building Assess existing programs and opportunities for training in research and methods of evaluation Work with countries to develop programs and TA where needed Focus on long-term impact: shift the focus from numbers trained to numbers shaping and driving the research agenda

43 PEPFAR Scientific Advisory Board (1) Created in accordance with the Federal Advisory Committee Act (FACA) and appointed by the Coordinator to: Serve in a solely advisory capacity concerning scientific, implementation, and policy issues related to the global response to HIV/AIDS Influence the priorities and direction of global evaluation and research under PEPFAR Indentify evidence gaps, especially those that PEPFAR is uniquely positioned to address Participate on subcommittees to develop specific recommendations on issues of particular importance to PEPFAR

44 PEPFAR Scientific Advisory Board (2) Members represent USG and non-usg experts in the national and international HIV/AIDS community including academia, multilateral and bilateral agencies, foundations, advocates, and non-governmental organizations Inaugural meeting held on January 6-7, 2011 in Washington DC Next meeting TBD (to be scheduled July or Sept 2011)

45 THANK YOU For more information, please visit: