Financial Resources for HIV: PEPFAR s Contributions to the Global Scale-up of Treatment

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Financial Resources for HIV: PEPFAR s Contributions to the Global Scale-up of Treatment Joint WHO & UNAIDS Consultation with Pharmaceuticals and Stakeholders November 05 2012 Lara Stabinski, MD, MPH Medical Officer Office of the U.S. Global AIDS Coordinator U.S. President s Emergency Plan for AIDS Relief (PEPFAR)

The US Response to AIDS 2003 PEPFAR Announced 2008 PEPFAR Reauthorized by the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act until 2013 Counseling and testing for 40 million people Support and care for 13 million people, including 4.1 million orphans and vulnerable children 660,000 HIV+ pregnant women supported on antiretroviral prophylaxis, 200,000 infant HIV infections averted

PEPFAR Saving Lives As of March 2012, 4.5 million people were directly supported on treatment by PEPFAR.

PEPFAR Contribution towards emtct 1000000 900000 800000 Pregnant women on ARVs for PMTCT 838624 941425 700000 600000 500000 400000 300000 383311 508466 587961 659994 APR Data PEPFAR Targets 200000 FY08 FY09 FY10 FY11 FY12 Target FY13 Target PEPFAR APR/COP

WHO Options A & B Eligible for Treatment 40-50% of pregnant women identified as HIV+ will be eligible for treatment for their own health (CD4 <350) CD4 <350 (40-50% of women) CD4 >350 (50-60% of women) Eligible for Prophylaxis 50-60% of pregnant women identified as HIV+ will have CD4> 350 and should receive prophylaxis under Options A or B ART Given Generally through referral to treatment site After CD4 results received: A) ART initiated B) ART (already initiated) continues Prophlaxis Given Generally at ANC site A) After CD4 results received B) After sample taken for CD4

Connecting PMTCT and Treatment 0.05.1.15.2 Proportion pregnant at ART start Using Science for Better Programming 2002 2004 2006 2008 Year of ART initiation Estimated proportion Observed proportion Pregnant Women represent an increasing proportion of all patients initiating combination antiretroviral therapy at PEPFAR sites. A recent study of PEPFAR programs in Kenya, Uganda, and Tanzania found that between 2002 and 2008 the prevalence of pregnancy at cart start increased from 2.6% to 16.0%. Holmes, et al, CROI 2012

Using Science for Better Programming Transforming PMTCT: Option B+ Option B+ provides full antiretroviral treatment for life for all HIV-positive pregnant women, regardless of CD4 10 PEPFAR countries are currently implementing, transitioning to, or considering Option B+ Recent developments suggest that substantial clinical and programmatic advantages can come from adopting a single, universal regimen both to treat HIV-infected pregnant women and to prevent mother-to-child transmission of HIV. -April 2012 WHO Programmatic Update on the use of antiretroviral drugs for treating pregnant women and preventing HIV infection in infants

Sources: and Kaiser Family Foundation analysis, July 2012; Global Fund to Fight AIDS, Tuberculosis and Malaria online data query, January 2012; UNITAID Annual Report ; UNITAID Audited Financial Report for the period -; OECD CRS online data queries. http://www.kff.org/hivaids/upload/7347-08.pdf PEPFAR Bilateral & Multilateral Investments $1,200 Trends in International AIDS Assistance from Donor Governments: Multilateral & Bilateral Funding, - USD million $5,000 $4,500 $1,000 Multilateral $4,000 $800 Bilateral $3,500 $3,000 $600 $2,500 $400 $2,000 $1,500 $200 $1,000 $500 $0 Australia Canada Denmark France Germany Ireland Italy Japan Netherlands Norway Sweden U.K. EC Other U.S. $0

Sources: and Kaiser Family Foundation analysis, July 2012; Global Fund to Fight AIDS, Tuberculosis and Malaria online data query, January 2012; UNITAID Annual Report ; UNITAID Audited Financial Report for the period -; OECD CRS online data queries. http://www.kff.org/hivaids/upload/7347-08.pdf A Shared Global Responsibility International AIDS Assistance: Donor Governments as Share of Bilateral Disbursements, Denmark 3.0% United Kingdom 11.7% Germany 2.6% Netherlands 4.7% United States 68.2% In, the U.S. accounted for 59% of all disbursements by donor governments -- and 68% of all bilateral disbursements Sweden 2.0% Australia 1.5% France 1.4% Ireland 1.2% Norway 1.1% Canada 0.8% Italy 0.1% Japan 0.4% Other Governments 0.7% European Commission 0.7%

USG Funding Fiscal Years, 2004-2012 For FY 2013, President Obama is requesting about 6.4 billion dollars for bilateral programs & GFATM.

Global Plan for Elimination of Mother-to-Child HIV Transmission US led effort to create global action plan toward eliminating new HIV infections among children by 2015 and keeping their mothers alive U.S. Pledge: $75 million in new PEPFAR PMTCT funding On top of the approximately $300 million in annual PMTCT funding Private Sector and Foundation Pledges: $40 million from Gates Foundation $20 million from Chevron $15 million from Johnson & Johnson

A Key Partner: The Global Fund US announced a historic $4 billion pledge over 3 years (FY -2013) to the Global Fund PEPFAR and the Global Fund account for over 90% of donor funding for HIV response in the world s highest-burden and lowest-resourced countries A 38% increase over past commitments U.S. has provided $7.3 billion to date 5.6 million persons on treatment received support through PEPFAR, the Global Fund, or both ()

A Shared Global Responsibility International AIDS Assistance: Donor Governments as Share of Global Fund Contributions by Donor Governments, Germany 9.3% Canada 6.0% France 15.6% United Kingdom 15.0% Japan 3.9% United States 32.3% Norway 2.6% Italy 0.0% In, the U.S. accounted for 32% of all donor contributions to the Global Fund Ireland 0.4% Denmark 1.0% Other Governments 1.4% Australia 1.4% European Commission Sweden 5.1% 3.0% Netherlands Sources: and Kaiser Family Foundation analysis, July 2012; Global Fund to Fight AIDS, Tuberculosis 3.0% and Malaria online data query, January 2012; UNITAID Annual Report ; UNITAID Audited Financial Report for the period -; OECD CRS online data queries. http://www.kff.org/hivaids/upload/7347-08.pdf

PEPFAR Moving Forward: A New Vision An AIDS-free generation would be one of the greatest gifts the United States could give to our collective future. Secretary of State Hillary Rodham Clinton, November 8, An AIDS-free generation means that: - -Virtually no children are born with the virus -As these children become teenagers and adults, they are at a far lower risk of becoming infected than they would be today -They have access to treatment that helps prevent them from developing AIDS and passing the virus to others Central to achieving this: combination prevention 14

New Presidential Targets for HIV/AIDS President Obama announced ambitious targets on World AIDS Day Antiretroviral Treatment: 6 Million People on ART by End of 2013 PMTCT: 1.5 Million Additional HIV+ Pregnant Women on ART or Prophylaxis by End of 2013 Male Circumcision: 4.7 Million Additional VMMCs by End of 2013

The Tipping Point. Globally, with accelerated combination prevention, UNAIDS estimates that the number of new infections will fall below the number of those newly eligible for ART by 2015 Estimated 16

PEPEPFAR Moving Forward FY 2013 Country Operation Plan Guidance Using Science for Better Programming Focus on evidence based interventions Investing strategically across the portfolio Increasing impact and efficiency Shared financial responsibility

PEPFAR Strategic Acceleration FY 2013

PEPFAR Drug Optimization At a global-level: Purchasing power to drive demand for ARV regimens with better profiles for TB, pregnancy, durability, toxicity and simplicity Build on the work CHAI, UNITAID and others have done to ensure manufacturers are moving toward more efficient process chemistry and co-formulations At country-level: Annual guidance to PEPFAR country teams encourages use of WHO guideline regimens and movement to FDCs; emphasizes support to national program guidelines committees PEPFAR works with SCMS and other ARV procurement partners to ensure that suppliers are responsive to the needs of the national programs we support

Conditions Enabling Cost Savings Return on investment in equipment, infrastructure, training Increased Efficiency of Programs and Healthcare Personnel Decreasing commodity costs

PEPFAR s per-patient Treatment Costs have Declined (now $335/year) with Greater Scale-up $1,200 PEPFAR Per-Patient Annual Treatment Cost No. of PEPFAR Direct ART Patients 3,500,000 $1,000 $800 $600 $400 $200 3,000,000 2,500,000 2,000,000 1,500,000 1,000,000 500,000 $- 2005 2006 2007 2008 0 Note: Per-patient budget allocation is estimated as lagged treatment allocation divided by end-ofreporting direct patients. 21

Savings in ARVs * JAMA,

International SCMS ARV Transport, by Mode Source: SCMS

Accelerating Efficiency Gains PEPFAR is gaining efficiencies that will enable greater impact of investments: Accelerating new service delivery models including nurse initiated ART, streamlining laboratory services, strategic service integration, and transition to local partners and governments Rapidly increased generation and use of economic and financial data to provide PEPFAR program managers with actionable data to create and document efficiency gains Rapid expansion of routinization of expenditure analyses- >information we re hoping can inform national processes Continuing to work toward greater pooled procurement and innovative sea and land-based delivery channels that reduce costs

Conclusions PEPFAR continues to have substantial resources and is working closely with national governments and donor partners such as the Global Fund to ensure coordination and maximum impact our collective investments Increased focus on evidence based interventions including treatment, PMTCT, VMMC and condoms PEPFAR plans to accelerate treatment to meet coverage gaps in higher burden/low resourced partner countries, and to maintain the scale-up in others in coordination with other donor partners Continued attention to efficiency of our service delivery operations will enable even greater health impacts in the future.

Thank You! For further information, please visit: www.pepfar.gov www.facebook.com/pepfar http://twitter.com/uspepfar