AIDS Drug Assistance Programs: A Lifeline for People With HIV
More than twenty years after the approval of the first antiretroviral and despite numerous advancements in the treatment of HIV, getting HIV-related medications to all those who need them remains a critical challenge, even in the United States. Throughout this time, ADAPs, or AIDS Drug Assistance Programs, have served as the medication lifeline for many people with HIV.
What Are ADAPs?
Part of the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White Program), ADAPs are the major source of prescription drugs for low-income people living with HIV/AIDS in the U.S. who have limited or no prescription drug coverage. The purpose of ADAPs, as stated in the Ryan White law, is to "provide therapeutics to treat HIV disease or prevent the serious deterioration of health arising from HIV disease in eligible individuals, including measures for the prevention and treatment of opportunistic infections".1 This is accomplished in two main ways -- providing Food and Drug Administration (FDA)-approved HIV-related prescription drugs to people living with HIV/AIDS and paying for health insurance (premiums, co-payments and deductibles) that includes coverage of HIV treatments.
When Did They Begin?
ADAPs began in 1987 as AZT Assistance Programs when the federal government provided grants to states to help them purchase the first FDA-approved antiretroviral, AZT, for people living with HIV/AIDS. As community members began demanding that treatment be accessible and that the federal government develop a response to the HIV/AIDS crisis, ADAPs were written into the newly created Ryan White CARE Act in 1990; in 1996, the Congress began earmarking funds for ADAPs specifically, as part of Ryan White. In that year, approximately 69,000 people were served by ADAPs.2 Today, close to 150,000 people are served.
How Do They Work?
Each state3 administers its own ADAP and is given flexibility under the Ryan White Program to design many aspects of the program, including client eligibility, drug purchasing and distribution arrangements, and drug formularies (although there are minimum requirements for including one drug from every class of antiretroviral medications). No standard client income eligibility level is required by law, although clients must be HIV-positive, low income and under- or uninsured. In June 2007, client eligibility levels ranged from 200% of the federal poverty level (FPL) in nine states to 500% FPL in six states. Twenty-five states had levels over 300% and 19 states had set their levels between 201% and 300% of the FPL (see Figure 1). The national ADAP budget in Fiscal Year 2007 was $1.43 billion. Major sources of revenue were federal funding through the Ryan White Program (54%), state general revenue funds (21%) and drug rebates from manufacturers (18%).4
Figure 1: ADAP Income Eligibility, December 31, 2007
ADAPs serve as "payer of last resort"; that is, they provide prescription medications to, or pay for health insurance premiums or maintenance for, people with HIV/AIDS when no other funding source is available to do so. Demand for ADAPs depends on the number of clients seeking services, the cost of medications, and the size of the prescription drug "gap" that ADAPs must fill in their jurisdiction. Larger gaps, such as in states with a less generous Medicaid program, may strain ADAP resources further than in others. This, coupled with an estimated annual (2007) drug cost for each ADAP client of nearly $12,000 and escalating prescription drug costs, places ADAPs under continual fiscal pressure to meet the demands for services.5
ADAPs are discretionary grant programs, dependent on annual funding from Congress, funding which may not correspond to the number of people who need prescription drugs. Therefore, annual federal appropriations and contributions from other sources (such as state funding), determine how many clients ADAPs can serve and the level of services they can provide. When demand for ADAPs exceeds available funding, as has been the case for much of the program, ADAPs have turned to a variety of cost containment measures, including waiting lists, reduced formularies or client eligibility, cost-sharing and/or expenditure limits (monthly or annual). Waiting lists, while not the only indicator of fiscal pressures within ADAPs, have been a steady element of ADAPs since 2002 when tracking began. The number of individuals on ADAP waiting lists reached a high of 1,629 in 11 states in 2004, and has fluctuated over time, most likely a result of variable funding levels and demand for services.6
What Are the Latest Program Trends?
Through a more than 10-year collaborative effort, the National Alliance of State and Territorial AIDS Directors (NASTAD) and the Henry J. Kaiser Family Foundation (Kaiser) have been working to collect data on ADAPs through The National ADAP Monitoring Project, which tracks the program on an annual basis. The most recent report, from April 2008, highlighted several key findings about ADAPs, including the following:7
Figure 2: ADAP Formulary Coverage of Antiretroviral Drugs, December 31, 2007
Among the factors contributing to the easing of past pressures for many states were:
As of the time of this writing, there are still several unknowns concerning the near and longer term outlook for ADAPs. It is still not clear, for example, how the recent changes in the Ryan White Program will affect ADAPs over time. ADAP earmark funding, for instance, is still expected to shift state-by-state as hold harmless requirements (provisions within the Ryan White law that protect jurisdictions from substantial losses in funding) and other provisions in the law play out. This is occurring against the larger backdrop of a more general economic downturn that is impacting state budgets, with many reporting overall budget shortfalls for Fiscal Year 2008 and/or expecting shortfalls for Fiscal Year 2009, which could stand to affect ADAPs.
In addition, Fiscal Year 2009 Congressional appropriations for ADAP have still not been completed by Congress. Both the House and Senate have proposed increases of approximately three percent over current levels, but differences between them must now be resolved. The pending national election could bring changes as well, with both presumptive Presidential nominees having mentioned the need to further address the growing HIV epidemic in the U.S. Furthermore, there is ongoing discussion nationally and at the state level about the need for broader health reform, and any changes in the larger health system will stand to affect ADAPs. What is clear is that ADAPs have and will continue to play a critical role in providing prescription medications to people with HIV/AIDS in the U.S. who would otherwise have nowhere else to go.
ADAPs have been highly successful in meeting the needs of uninsured and underinsured Americans with HIV. As the new President, Congress and states seek to affect changes in health care, the role of ADAP as a safety net program in our nation's larger health care system remains critical and must be at the forefront of health care reform discussions.
Murray Penner is Deputy Executive Director at the National Alliance of State and Territorial AIDS Directors (NASTAD).
Jen Kates is Vice President and Director of HIV Policy at the Kaiser Family Foundation.
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This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues. Visit GMHC's website to find out more about their activities, publications and services.