In May 2009, the President announced the creation of a new Global Health Initiative (GHI) and proposed $63 billion in funding for all global health programs, including HIV/AIDS, malaria, tuberculosis, and maternal and child health, through 2014. According to the proposal, the majority of this funding—$51 billion, or 81 percent—is slated for global HIV/AIDS, tuberculosis, and malaria programs. For fiscal year 2009, State and USAID allocated about $7.3 billion for global health and child survival programs, including more than $5.6 billion for HIV/AIDS programs. For fiscal year 2010, State and USAID allocated approximately $7.8 billion for global health and child survival programs, including $5.7 billion for HIV/AIDS. For fiscal year 2011, the President proposed spending $8.5 billion on global health and child survival programs, including $5.9 billion for HIV/AIDS. In February 2010, the administration released a consultation document on GHI implementation, focusing on coordination and integration of global health programs, among other things, and setting targets for achieving health outcomes. The document also proposed selection of up to 20 countries—known as GHI Plus countries—that will receive additional funding and technical assistance under the GHI. Congress first authorized PEPFAR in 2003 and, in doing so, created within State a Coordinator of the U.S. Government Activities to Combat HIV/AIDS Globally, which State redesignated the Office of the U.S. Global AIDS Coordinator (OGAC). OGAC establishes overall PEPFAR policy and program strategies; coordinates PEPFAR programs; and allocates PEPFAR resources from the Global Health and Child Survival account to U.S. implementing agencies, including USAID and the Department of Health and Human Services’ (HHS) CDC. USAID and CDC also receive direct appropriations to support global HIV/AIDS and other global health programs, such as tuberculosis, malaria, and support for maternal and child health. In fiscal years 2004 through 2008—the first 5 years of PEPFAR—the U.S. government directed more than $18 billion to PEPFAR implementing agencies and the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund). In 2008, Congress reauthorized PEPFAR at $48 billion to continue and expand U.S.-funded HIV/AIDS and other programs through fiscal year 2013. Although PEPFAR initially targeted 15 countries, known as focus countries, since its establishment PEPFAR has made significant investments in 31 partner countries and 3 regions. Representatives of PEPFAR implementing agencies (country teams) jointly develop country operational plans (COP) for the 15 focus countries and an additional 16 nonfocus countries, as well as regional operational plans (ROP) for three regions, to document U.S. investments in, and anticipated results of, U.S.- funded programs to combat HIV/AIDS. The country teams submit the operational plans to OGAC for review and ultimate approval by the U.S. Global AIDS Coordinator. As such, these operational plans serve as the basis for approving annual U.S. bilateral HIV/AIDS funding, notifying Congress, and allocating and tracking budgets and targets. Some nonfocus countries receiving U.S. HIV/AIDS funding do not submit a PEPFAR operational plan; OGAC reviews and approves HIV/AIDS-related foreign assistance funding through foreign assistance operational plans. Table 1 shows the countries and regions that received U.S. foreign assistance for HIV/AIDS programs in fiscal years 2001-2008. In 2009, UNAIDS estimated that $7 billion would be needed in developing countries in 2010 to reach HIV/AIDS treatment and care program targets, which are generally defined as 80 percent of the target population requiring treatment. Sub-Saharan Africa makes up about half (49 percent) of estimated needs for all HIV/AIDS programs in developing countries. UNAIDS’s estimate includes provision of ART, testing and counseling, treatment for opportunistic infections, nutritional support, laboratory testing, palliative care, and the cost of drug-supply logistics. The costs for CD4 blood tests are also included. In fiscal years 2006-09, PEPFAR funding for ART made up nearly half (46 percent) of PEPFAR’s approved budget for prevention, treatment, and care programs. (See fig. 1.) ART funding generally comprised treatment services (about 55 percent of approved treatment funding); ARV drug procurement (about 32 percent of approved treatment funding); and laboratory infrastructure (about 13 percent of approved treatment funding). In 2008, OGAC reported that tentative approval of generic ARV drugs had generated significant savings for PEPFAR. As of September 2010, HHS’s Food and Drug Administration had approved, or tentatively approved, 116 ARV formulations under its expedited review process, which allows all ARV drugs to be rapidly reviewed for quality standards and subsequently cleared for purchase under PEPFAR. According to PEPFAR’s Five-Year Strategy, released in December 2009, PEPFAR plans to provide direct support for more than 4 million people on ART, more than doubling the number of people directly supported on treatment during the first 5 years of PEPFAR. The strategy seeks to focus PEPFAR support on specific individuals requiring ART by prioritizing individuals with CD4 cell counts under 200/mm In addition, in countries with high coverage rates that are expanding eligibility for treatment, PEPFAR will provide technical assistance and support for the overall treatment infrastructure. PEPFAR also will expand efforts to better link testing and counseling with treatment and care and, in conjunction with its prevention of mother-to-child transmission programs, will support expanded treatment to pregnant women. As we have previously reported, federal financial standards call on agencies to use costing methods in their planning to determine resources needed to evaluate program performance, among other things. Program managers should use costing information to improve the efficiency of programs. In addition, such information can be used by Congress to make decisions about allocating financial resources, authorizing and modifying programs, and evaluating program performance. In 2008, we found that PEPFAR country teams identified and analyzed program costs in varying ways, and we recommended that the Secretary of State direct OGAC to provide guidance to PEPFAR country teams on using costing information in their planning and budgeting. irrespective of clinical symptoms. See Rapid Advice: Antiretroviral therapy for HIV Infection in Adults and Adolescents (Geneva: WHO, 2009), www.who.int/entity/hiv/pub/arv/rapid_advice_art.pdf. Overall, U.S. bilateral spending on global HIV/AIDS and other health programs generally increased in fiscal years 2001 through 2008, particularly for HIV/AIDS programs. From 2001 through 2003, U.S. bilateral spending on global HIV/AIDS rose, while spending on other global health programs dropped slightly. As would be expected given PEPFAR’s significant investment, from fiscal years 2004 through 2008, U.S. bilateral HIV/AIDS spending showed the greatest increase in PEPFAR focus countries, relative to nonfocus countries and regions with PEPFAR operational plans and other countries receiving HIV/AIDS assistance. In addition, our analysis determined that U.S. spending for other health- related health assistance also increased most for PEPFAR focus countries. Spending growth rates varied among three key regions—sub-Saharan Africa, Asia, and Latin America and the Caribbean—as did these regions’ shares of bilateral HIV/AIDS and other health spending following establishment of PEPFAR. (See app. II for additional information on U.S. bilateral foreign assistance spending on HIV/AIDS and other health programs in fiscal years 2001 through 2008.) Overall, U.S. bilateral foreign assistance spending on both global HIV/AIDS and other health programs increased in fiscal years 2001 through 2008. Although spending on other health programs decreased slightly from 2001 through 2003, U.S. spending on both HIV/AIDS and other health-related foreign assistance programs grew from 2004 through 2008, the first 5 years of PEPFAR. Annual growth in U.S. spending on global HIV/AIDS was more robust and consistent than annual growth for other global health spending (see table 2 and fig. 2). 2001-2003. Prior to the implementation of PEPFAR, U.S. bilateral spending on HIV/AIDS programs grew rapidly, while U.S. spending on other health programs fell slightly. HIV/AIDS. The U.S. government spent less on global HIV/AIDS programs than on other health-related programs in fiscal years 2001-2003. However, spending on HIV/AIDS grew rapidly prior to implementation of PEPFAR. Other health. U.S. spending on other health-related programs decreased from 2001 to 2003. However, total spending for these programs during this period was more than three times greater than the total for HIV/AIDS- related foreign assistance programs. 2004-2008. Following implementation of PEPFAR, U.S. bilateral spending on both global HIV/AIDS and other health-related programs increased overall, with more rapid and consistent growth in spending for HIV/AIDS programs. HIV/AIDS. In fiscal year 2004, U.S. spending on HIV/AIDS programs was roughly equivalent to the total for the previous 3 years combined; in fiscal year 2008, annual U.S. spending on global HIV/AIDS programs was nearly three times the 2004 total. In addition, U.S. spending on HIV/AIDS programs in 2005 was, for the first time, higher than spending on other health programs. By 2008, almost twice as much was spent on HIV/AIDS programs as on other health programs. Other health. Although U.S. spending on other health programs also increased overall from fiscal year 2004 through 2008, annual spending was less consistent and decreased in 2006 and 2007. Our analysis shows differences in growth trends in U.S. bilateral spending on HIV/AIDS and other health programs before and after implementation of PEPFAR for three distinct groups of countries: PEPFAR focus countries, nonfocus countries and regions with PEPFAR operational plans, and all other countries receiving HIV/AIDS foreign assistance (i.e., nonfocus countries receiving HIV/AIDS assistance that do not submit PEPFAR operational plans to OGAC). In fiscal years 2001 through 2003, U.S. bilateral spending on global HIV/AIDS programs grew for countries in all three groups, while spending on other health programs increased at lower rates. From 2004 through 2008, the average annual growth rate in U.S. bilateral spending on global HIV/AIDS programs was, predictably, greatest in focus countries, as was spending on other health programs in these countries (see table 3). For the 15 countries that would become PEPFAR focus countries, U.S. bilateral spending on both HIV/AIDS and other health programs increased steadily from 2001 through 2003, with higher growth for HIV/AIDS spending. From 2004 through 2008, U.S. bilateral spending on global HIV/AIDS-related foreign assistance programs continued to increase significantly, while spending on other health programs grew modestly overall. From 2004 through 2008, total U.S. bilateral spending on HIV/AIDS-related foreign assistance programs in PEPFAR focus countries was more than seven times greater than spending on other health programs. (See fig. 3.) For the 16 nonfocus countries and three regions that eventually would submit operational plans to receive PEPFAR funding, U.S. bilateral spending on both HIV/AIDS and other health-related foreign assistance programs increased from 2001 through 2003 (see fig. 4), but at lower rates and less consistently than for the focus countries. From 2001 through 2003, U.S. bilateral spending on other health-related foreign assistance programs was about three times greater than spending on HIV/AIDS programs in these countries and regions, although spending on HIV/AIDS programs grew more rapidly. From 2004 through 2008, U.S. bilateral spending on both global HIV/AIDS and other health programs increased overall, with greater spending on other health programs for the 5-year period. In all other countries that received some U.S. assistance for HIV/AIDS programs from 2001 through 2008 but did not submit PEPFAR operational plans—a total of 47 countries—U.S. bilateral spending on both HIV/AIDS and other health-related foreign assistance programs fluctuated from year to year but increased overall (see fig. 5). In addition, U.S. bilateral spending for other health programs greatly exceeded spending for HIV/AIDS programs both before and after the establishment of PEPFAR. From 2001 through 2003, U.S. bilateral spending on HIV/AIDS programs in these countries nearly quadrupled; spending on other health programs amounted to more than 12 times that for HIV/AIDS programs and increased slightly over the period. From 2004 through 2008, U.S. bilateral spending on other health programs continued to greatly exceed spending on HIV/AIDS-related programs in these countries; spending on both HIV/AIDS and other health programs fluctuated from year to year and grew at similar rates overall. In fiscal years 2001 through 2008, the majority of U.S. bilateral HIV/AIDS program spending was in sub-Saharan Africa, Asia, and Latin America and the Caribbean—three regions where the 15 PEPFAR focus countries and 14 of the 16 nonfocus countries with PEPFAR operational plans are located—with the greatest U.S. spending on global HIV/AIDS foreign assistance programs in sub-Saharan Africa. From 2004 through 2008, following the establishment of PEPFAR, the share of U.S. bilateral spending on other health programs directed to countries in sub-Saharan Africa and Latin America and the Caribbean declined, while the share of U.S. spending on other health programs in Asia and in other regions increased. (See fig. 6.) Average annual growth rates in spending on HIV/AIDS and other health programs also varied significantly across these three regions (see table 4). ble 4: Average Annual Growt Ta Related Foreign Assistance Spending, by Region, Fiscal Years 2001-2008 h Rates for Global U.S. Latin America and the Caribbean PEPFAR period (first 5 years) U.S. bilateral foreign assistance spending on HIVAIDS programs in sub- Saharan Africa—which includes 12 of the 15 focus countries and 8 of the 16 nonfocus countries with PEPFAR operational plans— increased rapidly both before and after the establishment of PEPFAR. In 2003, U.S. bilateral spending on HIV/AIDS programs was nearly two times greater, and by 2008 was more than four times greater than spending on other health programs. U.S. bilateral spending on other health programs declined overall from 2001 to 2003 and remained steady from 2004 to 2007, but began to grow substantially in 2008. (See fig. 7.) U.S. bilateral foreign assistance spending on both HIVAIDS and other health-related foreign assistance programs in Asia—where 1 of the 15 focus countries as well as 5 nonfocus countries and 1 region that submit PEPFAR operational plans are located—increased overall from 2001 to 2008. Overall bilateral spending on other health programs was three times larger than spending on HIV/AIDS programs throughout the period. (See fig. 8.) From 2001 through 2008, total U.S. bilateral foreign assistance spending on HIVAIDS programs in Latin American and the Caribbean—where 2 of the 15 focus countries as well as a nonfocus country and two regions with PEPFAR operational plans are located— increased continuously. During this period, U.S. bilateral spending on other health programs in these countries and regions fluctuated from year to year and declined overall. Bilateral spending on other health programs was consistently greater than spending on HIV/AIDS programs during this period; however, in 2008, annual spending on HIV/AIDS programs was nearly equal to spending for other health programs (see fig. 9). To inform policy and program decisions related, in part, to expanding efforts to provide ART in developing countries, OGAC, USAID, and UNAIDS have adopted three different models for ART cost analyses. OGAC uses the PEPFAR ART Costing Project Model (PACM) to estimate and track PEPFAR-supported ART costs in individual PEPFAR countries and across these countries. USAID and its partners use the HIV/AIDS Program Sustainability Analysis Tool (HAPSAT) to estimate resources needed to meet individual countries’ ART goals, among other things. UNAIDS and USAID use a suite of models referred to as Spectrum to project ART costs in individual countries and globally. Table 5 provides information on the three costing models. For additional information on the components of these three models, see appendix III. Although the models have different purposes, a 2009 comparison study conducted by their developers found that the three models produced similar overall ART cost estimates given similar data inputs. According to the models’ developers, data used for one model can be entered into another to generate cost estimates and projections. For example, cost data collected in Nigeria for use in HAPSAT were also used in PACM to inform PEPFAR global average treatment cost estimates. Such cost projections also can help decision makers to estimate the cost-related effects of policy and protocol changes, such as changes made in response to the World Health Organization’s November 2009 recommendation that HIV patients initiate ART at an earlier stage of the disease’s progression. In coordination with HHS and USAID, State’s OGAC reviewed a draft of this report and provided technical comments, which we incorporated as appropriate. We are sending copies of this report to the Secretary of State, the Office of the Global AIDS Coordinator, USAID Office of HIV/AIDS, HHS Office of Global Health Affairs, and CDC Global AIDS Program. In addition, the report will be available at no charge on the GAO Web site at http://www.gao.gov. If you or your staffs have any questions about this report, please contact me at (202) 512-3149 or gootnickd@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made major contributions to this report are listed in appendix IV. Responding to legislative directives, this report examines U.S. bilateral foreign assistance spending on global HIV/AIDS and other health-related programs in fiscal years 2001-2008. The report also provides information on models used to estimate HIV treatment costs. To examine trends in U.S. bilateral spending on global HIV/AIDS- and other health-related foreign assistance programs, we analyzed data from the Foreign Assistance Database (FADB) provided by the U.S. Agency for International Development (USAID), interviewed State Department, USAID, and Health and Human Services (HHS) officials in Washington, D.C., and Centers for Disease Control and Prevention (CDC) officials in Atlanta. We also interviewed representatives of the Kaiser Family Foundation who have conducted similar research and analysis. We reviewed relevant articles and reports regarding international and U.S. global health assistance funding and examined relevant data on other donor and U.S. foreign assistance. Congress, U.S. agencies, and research organizations use varying definitions of global health programs, with inclusion of safe water and nutrition programs being one varying factor among definitions. Congress funds global health programs through a number of appropriations accounts: Foreign Operations; Labor, Education and Health; and Defense; and through several U.S. agencies. The State Department, USAID, and the HHS’ CDC are the primary U.S. agencies receiving congressional appropriations to implement global health programs, including programs to combat HIV/AIDS. Through foreign operations accounts administered by USAID and State, Congress specifies support for five key global health programs: child survival and maternal health, vulnerable children, HIV/AIDS, other infectious diseases, and family planning and reproductive health. In addition, Congress specifies support for five key CDC global health programs: HIV/AIDS, malaria, global disease detection, immunizations, and other global health. CDC also allocates part of its tuberculosis and pandemic flu budget for international programs, and State and USAID may transfer funds to CDC for specific activities. In addition to these programs, USAID and CDC include other programs related to global health. For example, USAID reports specific nutrition and environmental health programs in its global health portfolio. Likewise, CDC also uses its resources to provide international technical assistance when requested, such as for disease outbreak response (e.g., pandemic influenza preparedness and prevention), or reproductive health. The Committee on the U.S. Commitment to Global Health at the Institute of Medicine (IOM) defined global health programs as those aimed at improving health for all people around the world by promoting wellness and eliminating avoidable disease, disability and death. According to the Organisation for Economic Cooperation and Development (OECD), global health includes the following components: health care; health infrastructure; nutrition; infectious disease control; health education; health personnel development; health sector policy, planning and programs; medical education, training and research; and medical services. In its report on donor funding for global health, the Kaiser Family Foundation combined data from four OECD categories to construct its definition of global health: health; population policies and programs and reproductive health (which includes HIV/AIDS and sexually transmitted diseases); water supply and sanitation; and other social infrastructure and services. For the purposes of this report, we defined U.S. global spending for HIV/AIDS programs as foreign assistance for activities related to HIV/AIDS control, including information, education, and communication; testing; prevention; treatment; and care. We defined U.S. spending for other health-related programs as foreign assistance for general and basic health and population and reproductive health policies and programs (except those related to HIV/AIDS). General and basic health includes health policy and administrative management, medical education and training, medical research, basic health care, basic health infrastructure, basic nutrition, infectious disease control, health education, and health personnel development. Population and reproductive health policies and programs include population policy and administrative management, reproductive health care, family planning, and personnel development for population and reproductive health. The specific analyses presented in this report examine disbursement levels and growth trends from fiscal years 2001 to 2008 for bilateral HIV/AIDS and other health-related foreign assistance programs by time period (pre- PEPFAR and first 5 years of PEPFAR for all countries); PEPFAR country status (focus countries with PEPFAR operational plans, nonfocus countries with PEPFAR country or regional operational plans, and other nonfocus countries receiving HIV/AIDS-related foreign assistance from 2001 to 2008); and region (sub-Saharan Africa, Latin America and the Caribbean, and Asia, which received the majority of U.S. spending on bilateral HIV/AIDS-related foreign assistance). We examined disbursements—amounts paid by federal agencies to liquidate government obligations—of U.S. bilateral foreign assistance for global HIV/AIDS and other health programs, because, unlike other data, disbursement data directly reflect the foreign assistance reaching partner countries. We used USAID’s deflator to convert nominal dollar amounts to constant 2010 dollar amounts, which are appropriate for spending trend analysis. As such, it is important to remember that the disbursement figures for HIV/AIDS- and other health-related foreign assistance programs presented in this report differ from appropriation or commitment data which may be reported elsewhere. Because we focused on bilateral disbursements, our analysis excludes U.S. contributions to the Global Fund to Fight HIV/AIDS, Tuberculosis, and Malaria. In addition, about $4.7 billion and $3.3 billion in disbursements for HIV/AIDS programs and other health-related foreign assistance programs, respectively, from 2001 to 2008, were not specified for an individual country or region in the FADB. As such, our analysis of bilateral spending levels and growth trends by PEPFAR country status and geographical region excludes these disbursements. We assessed the reliability of disbursement data from the FADB and determined them to be sufficiently reliable for the purposes of reporting in this manner. In assessing the data, we interviewed USAID officials in charge of compiling and maintaining the FADB, reviewed the related documentation, and compared data to published data from other sources. We also determined that, in general, USAID takes steps to ensure the consistency and accuracy of the disbursements data reported by U.S. government agencies, including by verifying possible inconsistencies or anomalies in the data received, providing guidance and other communications to agencies about category definitions, and comparing the data to other data sources. Although we did not assess the reliability of the data for complex statistical analyses, we determined that the data did not allow the identification of causal relationships between funding levels over time or among relevant categories; as such, we did not attempt an empirical analysis of the impact of PEPFAR on other health funding. To describe models used to estimate the cost of providing antiretroviral therapy (ART), we interviewed State Office of the Global AIDS Coordinator, USAID and CDC officials in Washington, D.C., and Atlanta. We also interviewed Joint United Nations Programme on HIV/AIDS (UNAIDS) officials in Washington, D.C. and Geneva, Switzerland, as well as developers of the costing models. We analyzed user manuals and guides for these models, as well as spreadsheets and additional information and technical comments provided by the U.S. agencies and model developers. We reviewed relevant literature for information on ART costing models, as well as the Leadership Act and previous GAO work regarding requirements and importance of cost information for program decision making. For fiscal years 2001 to 2008, U.S. bilateral foreign assistance spending for HIV/AIDS-related health programs varied significantly by country for both the 15 PEPFAR focus countries and the 16 countries and three regions with PEPFAR operational plans. Table 6 presents U.S. bilateral foreign assistance spending in constant dollars, by country, on HIV/AIDS programs, for fiscal years 2001-2008. As noted in appendix I, we converted nominal dollar amounts to constant 2010 dollars, which are appropriate for analysis of trends in U.S. foreign assistance spending in global health, but do not represent in-year actual spending amounts. For fiscal years 2001 to 2008, U.S. bilateral foreign assistance spending for other health programs also varied significantly by country for both the 15 PEPFAR focus countries and the 16 countries and three regions with PEPFAR operational plans. Table 7 presents U.S. bilateral foreign assistance spending in constant dollars, by country, on other health-related (i.e., non-HIV/AIDS) programs, for fiscal years 2001-2008. As noted in appendix I, we converted nominal dollar amounts to constant 2010 dollars, which are appropriate for analysis of trends in U.S. foreign assistance spending in global health, but do not represent in-year actual spending amounts. To estimate total cost of ART, three key models—the PEPFAR ART Costing Project Model (PACM), HIV/AIDS Program Sustainability Analysis Tool (HAPSAT), and Spectrum—all consider the number of patients and various drug and nondrug cost estimates. PACM and HAPSAT also address overhead costs in total cost calculations. This appendix presents the specific drug and nondrug costs that each model considers in making estimates. PACM categorizes ART patients as adult or pediatric, new or established, receiving first- or second-line ARV drugs, receiving generic or innovator ARV drugs, and living in a low- or middle-income country. In addition, PACM considers the following cost categories: Drug costs. PACM categorizes ARV drug costs as generic or innovator and first- or second-line. For each of these categories, PACM accounts costs associated with supply chain, wastage, inflation, and ARV buffer stock. Nondrug costs. PACM categorizes nondrug costs as recurrent and investment costs. Recurrent costs include personnel, utilities, building, lab supplies, other supplies, and other drugs; facility-level management and overhead costs are also captured. Investment costs include training, equipment, and construction. Overhead. PACM categorizes above-facility-level overhead costs as U.S. government, partner government, and implementing partner overhead, as well as U.S. government indirect support to partner governments (e.g., U.S. government support for system strengthening or capacity building of the national HIV/AIDS program). Table 8 summarizes how PACM categorizes numbers of patients and various unit costs to calculate the total cost of ART based on estimates of PEPFAR and non-PEPFAR shares of costs derived from PEPFAR-funded empirical studies. HAPSAT categorizes current ART patients as those receiving first- or second-line ARV drugs. In addition, HAPSAT considers the following cost categories: Drug costs. HAPSAT categorizes drug costs as first- or second-line ARV drugs. Nondrug costs. HAPSAT categorizes nondrug costs as labor (e.g., doctor, nurse, lab technician salaries) and laboratory costs. Overhead. HAPSAT categorizes overhead as administrative costs, drug supply chain, monitoring and evaluation, and training, based on country data. Overhead estimates are applied at both the facility and above-facility level. Table 9 summarizes how HAPSAT categorizes numbers of patients and various unit costs to calculate the total cost of ART. Spectrum categorizes current ART patients as adult or pediatric and receiving first- or second-line ARV drugs. In addition, Spectrum considers the following cost categories: Drug costs. Spectrum categorizes drugs costs as first- or second-line ARV drugs. Nondrug costs. Spectrum categorizes nondrug costs as laboratory and service delivery (i.e., hospital and clinic stays). Service delivery costs include inpatient hospital and outpatient clinic costs. Table 10 summarizes how Spectrum categorizes numbers of patients and various unit costs to calculate the total cost of ART. In addition to the contact named above, Audrey Solis (Assistant Director), Todd M. Anderson, Diana Blumenfeld, Giulia Cangiano, Ming Chen, David Dornisch, Lorraine Ettaro, Etana Finkler, Kendall Helm, Heather Latta, Reid Lowe, Grace Lui, Jeff Miller, and Mark Needham made key contributions to this report. President’s Emergency Plan for AIDS Relief: Efforts to Align Programs with Partner Countries’ HIV/AIDS Strategies and Promote Country Ownership. GAO-10-836. Washington, D.C.: September 20, 2010. President’s Emergency Plan for AIDS Relief: Partner Selection and Oversight Follow Accepted Practices but Would Benefit from Enhanced Planning and Accountability. GAO-09-666. Washington, D.C.: July 15, 2009. Global HIV/AIDS: A More Country-Based Approach Could Improve Allocation of PEPFAR Funding. GAO-08-480. Washington, D.C.: April 2, 2008. Global Health: Global Fund to Fight AIDS, TB and Malaria Has Improved Its Documentation of Funding Decisions but Needs Standardized Oversight Expectations and Assessments. GAO-07-627. Washington, D.C.: May 7, 2007. Global Health: Spending Requirement Presents Challenges for Allocating Prevention Funding under the President’s Emergency Plan for AIDS Relief. GAO-06-395. Washington, D.C.: April 4,2006. Global Health: The Global Fund to Fight AIDS, TB and Malaria Is Responding to Challenges but Needs Better Information and Documentation for Performance-Based Funding. GAO-05-639. Washington, D.C.: June 10, 2005. Global HIV/AIDS Epidemic: Selection of Antiretroviral Medications Provided under U.S. Emergency Plan Is Limited. GAO-05-133. Washington, D.C.: January 11, 2005. Global Health: U.S. AIDS Coordinator Addressing Some Key Challenges to Expanding Treatment, but Others Remain. GAO-04-784. Washington, D.C.: July 12, 2004. Global Health: Global Fund to Fight AIDS, TB, and Malaria Has Advanced in Key Areas, but Difficult Challenges Remain. GAO-03-601. Washington, D.C.: May 7, 2003.

Summary: U.S. funding for global HIV/AIDS and other health-related programs rose significantly from 2001 to 2008. The President's Emergency Plan for AIDS Relief (PEPFAR), reauthorized in 2008 at $48 billion through 2013, has made significant investments in support of prevention of HIV/AIDS as well as care and treatment for those affected by the disease in 31 partner countries and 3 regions. In May 2009, the President proposed spending $63 billion through 2014 on global health programs, including HIV/AIDS, under a new Global Health Initiative. The Office of the U.S. Global AIDS Coordinator (OGAC), at the Department of State (State), coordinates PEPFAR implementation. The Centers for Disease Control and Prevention (CDC) and the U.S. Agency for International Development (USAID), among other agencies, implement PEPFAR as well as other global health-related assistance programs, such as maternal and child health, infectious disease prevention, and malaria control, among others. Responding to legislative directives, this report examines U.S. disbursements (referred to as spending) for global HIV/AIDS- and other health-related bilateral foreign assistance programs (including basic health and population and reproductive health programs) in fiscal years 2001-2008. The report also provides information on models used to estimate HIV treatment costs. GAO analyzed U.S. foreign assistance data, reviewed HIV treatment costing models and reports, and interviewed U.S. and UNAIDS officials. In fiscal years 2001-2008, bilateral U.S. spending for HIV/AIDS and other health-related programs increased overall, most significantly for HIV/AIDS. From 2001 to 2003--before the establishment of PEPFAR--U.S. spending on global HIV/AIDS programs rose while spending on other health programs dropped slightly. From fiscal years 2004 to 2008, HIV/AIDS spending grew steadily; other health-related spending also rose overall, despite declines in 2006 and 2007. As would be expected, U.S. bilateral HIV/AIDS spending showed the most increase in 15 countries--known as PEPFAR focus countries--relative to other countries receiving bilateral HIV/AIDS assistance from fiscal years 2004 through 2008. In addition, GAO's analysis showed that U.S. spending on other health-related bilateral foreign assistance also increased most for PEPFAR focus countries. Spending growth rates varied among three key regions--sub-Saharan Africa, Asia, and Latin America and the Caribbean--as did these regions' shares of HIV/AIDS and other health foreign assistance spending following establishment of PEPFAR. OGAC, USAID, and UNAIDS have adopted three different models to estimate and project antiretroviral therapy (ART) costs. The three models--respectively known as the PEPFAR ART Costing Project Model, the HIV/AIDS Program Sustainability Analysis Tool, and Spectrum--are intended to inform policy and program decisions related, in part, to expanding efforts to provide ART in developing countries.