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The Importance of RWHAP Part B AIDS Drug Assistance Programs

Section 1

Following the March 1987 U.S. Food and Drug Administration (FDA) approval of zidovudine (Retrovir; AZT), the first antiretroviral with demonstrated efficacy as a treatment for AIDS, concerns emerged regarding the high cost of the drug – approximately $9,000 a year in 1987; roughly $23,500 in 2023 dollars – and the access challenges faced by PLWHA with limited insurance and financial resources. In response, the Health Resources and Services (HRSA) launched the AZT Drug Reimbursement Program in late 1987, with Congressional funds appropriated to all 50 states to support purchasing of the drug for uninsured and underinsured PLWHA. Grant award amounts were determined using a formula based on the number of people living with AIDS in each state, with New York, California, Texas, Florida, and New Jersey receiving 71 percent of the $30 million funds distributed.

These programs laid the groundwork for AIDS Drug Assistance Programs (ADAPs) authorized by Congress under the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act of 1990. Since the first reauthorization of the CARE Act in 1996, ADAPs have been funded as a separate line item under Title II of the CARE Act – Ryan White HIV/AIDS Program Part B – and remain charged with ensuring access to lifesaving ARV drugs and biologics, “A1” opportunistic infection medications, and outpatient medications for comorbid conditions that disproportionately impact PLWHA and/or affect the adherence to, or effectiveness of, ARV treatment.

ADAPs are able to support access to prescription drugs through two mechanisms: (1) by paying for any client medications on the program’s formulary, with significant up-front discounting and/or back-end rebating made possible via the 340B Drug Pricing Program (including voluntary supplemental discounting secured via the Apexus Prime Vendor Program or special pricing negotiations between manufacturers and the ADAP Crisis Task Force); and (2) as authorized by Congress under the second reauthorization of the CARE ACT in 2000, by paying for a portion or all of a client’s premiums and cost sharing (including deductibles, copayments, and coinsurance costs) for private or public insurance that includes prescription drug coverage. The CARE Act enables ADAPs to cover a broad array of medications with a limited number of requirements (e.g., all medications and ancillary devices must be FDA-approved). ADAPs’ expansive coverage is critical to their success and consistent with overall goals of the RWHAP to meet the comprehensive and evolving pharmaceutical needs of PLWHA, including access to novel antiretroviral medications (including provider-administered drugs and biologics), curative hepatitis C treatments, substance use medications, mental health medications, and sex hormones for gender-affirming therapy.

For more than 30 years, ADAPs have been at the forefront of pharmacoequity efforts in the U.S.– ensuring that all PLWHA, regardless of race, ethnicity, gender, sexual orientation, socioeconomic status, or availability of resources have access to high quality, state-of-the-art medications needed to manage their HIV infection and health.

Advancing pharmacoequity across the therapeutic continuum.

Advancing pharmacoequity across the therapeutic continuum. The figure represents the therapeutic continuum or the process through which a prescription drug makes its way to a patient. This process includes: 1) drug development, 2) drug trials and testing, 3) drug prescription, 4) drug receipt, and 5) drug adherence. At each step along this continuum, there is an opportunity to advance equity.

Source: Essien UR, Corbie G. Getting Under the Skin: Race-Based Guidelines and the Pursuit of Pharmacoequity. J Gen Intern Med. 2022 Dec;37(16):4035-4036. doi: 10.1007/s11606-022-07776-y.

The RWHAP was last reauthorized in 2009 and the most recent authorization sunset ended September 30, 2013. The program continues to effectively operate as Congress maintains annual appropriations to it.

Ending the HIV Epidemic (EHE) Initiative

In February 2019, the White House administration announced Ending the HIV Epidemic: A Plan for America (EHE), which remains the federal government’s plan to end the HIV epidemic by 2030. The plan’s goals are to reduce new HIV infections by 75% by 2025 and 90% by 2030. EHE is focused on four pillars: (1) diagnose all PLWHA as early as possible; (2) treat PLWHA rapidly and effectively to achieve sustained viral suppression; (3) prevent new HIV transmission by using proven interventions, including pre-exposure prophylaxis (PrEP) and syringe services programs (SSPs); and (4) respond urgently to HIV clusters and potential outbreaks to get needed prevention and treatment services to the communities who need them.

As a part of the EHE initiative, Phase 1 jurisdictions were required to develop EHE plans focused on implementing strategic activities across the four pillars. Even before the EHE initiative was announced in 2019, many cities, counties, and states had already developed, or were in the process of developing, EHE plans in their jurisdiction. These plans, which were often community-led, continue to be dynamic and can be accessed via NASTAD’s jurisdictional interactive map of EHE plans.

ADAPs are critical to jurisdictional and national EHE efforts at all levels, including the federal EHE initiative, by providing streamlined and continuous access to safe and effective antiretroviral therapy and other essential medications. ADAPs are also integral to “undetectable = untransmittable (U=U)”, an evidenced-based global campaign championing the fact that PLWHA who are on antiretroviral treatment and durably virally suppressed (i.e., viral load  200 copies/mL) cannot sexually transmit HIV.