Meeting the Need: Ensuring Access to Essential Medicines for People Living with HIV/AIDS

In CY2021, among the 47 jurisdictions responding to the annual RWHAP Part B ADAP Monitoring Project survey, 233,189 clients were served by ADAPs, representing 20% of the nearly 1.2 million people estimated to be living with HIV in the United States at the end of 2019. Approximately 46% were served by ADAPs’ full-pay medication programs only², 42% were served by the ADAP-funded insurance program only³, and 12% were served by both the ADAP-funded insurance program and the full-pay medication program.⁴

To fulfill their mission and purpose in supporting equitable access to treatment and optimal health outcomes, ADAPs must develop and maintain systems that are responsive to the challenges faced by their clients. As stipulated by the Ryan White CARE Act, individuals served by RWHAP and ADAP are low-income and under/uninsured. Among all ADAP clients served during CY2021 in a responding jurisdiction, 44% had incomes at or below 100% of the federal poverty level (FPL) whereas 11.6% of the general population were living at or below the FPL in 2021. The majority (68%) of ADAP clients served in CY2021 had incomes at or below 200% FPL. 

Less than half (43%) of ADAP clients served in CY2021 were Black, brown, indigenous, or other people of color, with the majority of clients of color reported as Black/African American. For a five-year comparison, the proportions of ADAP clients who are Black/African American in CY2021 (37%) has not changed significantly compared with CY2016 (39%). The proportion of ADAP clients who are white has increased, from 48% in CY2016 to 55% in CY2021.  

By ethnicity, 31% of ADAP clients served in CY2021 were reported as Hispanic/Latinx, compared with 26% of ADAP clients served in CY 2016.⁵

The majority of ADAP clients served in CY2021 identified as male (79%) whereas 19% identified as female and 1% as transgender. Comparatively, 49% and 51% of the U.S. population in 2021 were reported as male and female, respectively.  This difference is reflective of the disproportionate prevalence of HIV among men nationally; 78% of all adult and adolescent PLWHA in 2019 were male.

Effective antiretroviral regimens have enabled many PLWHA, including ADAP clients, to achieve a near-normal life expectancy and experience fewer AIDS-related conditions (e.g., opportunistic infections). As a result, the proportion of ADAP clients who are older – and consequently facing an increased risk of non-AIDS-related health complications (e.g., cardiovascular disease and cancer) and/or potentially requiring wrap-around support for outpatient medications covered under Medicare Part B or D – has and will continue to grow. In CY2021, the majority (57%) of ADAP clients served were 45 years or older; 11% were 65 years or older. Comparatively, in CY2016, while the same percentage of clients were 45 years and older, 8% were 65 years or older.

To help ensure that RWHAP maintains access to essential treatment, care, and support services, HRSA HAB released in October 2021 Policy Clarification Notice (PCN) 21-02, Determining Client Eligibility and Payor of Last Resort in the Ryan White HIV/AIDS Program (RWHAP). The updated guidance eliminates the six-month client eligibility recertification requirement for RWHAP programs, including ADAPs, instead allowing recipients and subrecipients to conduct timely eligibility confirmation in accordance with their own policies and procedures. The PCN also states affirmatively that immigration status is irrelevant for the purposes of eligibility for RWHAP services.

As of July 1, 2022, 32 of 47 responding ADAPs have moved to eliminate the six-month recertification requirement. A number of ADAPs are also involved in jurisdiction-wide efforts to adopt unified enrollment policies and procedures across RWHAP parts.

Virologic Suppression Outcomes

Eighty-three percent of ADAP clients served by the 47 jurisdictions providing data were reported as being virally suppressed based on their most recent viral load recorded as of December 31, 2021. This is significantly more than the estimated 65.5% of all people living with diagnosed HIV infection who were virally suppressed by year-end 2018 and alive by year-end 2019.

For a five-year comparison, 81% of ADAP clients served in CY2016 were reported as virally suppressed (52 programs reporting data). Sixty-three percent of ADAP clients served in 2014 were reported as virally suppressed, the earliest year in which these data were available (47 programs reporting data). This significant change over time is a testament to the increasing effectiveness of ADAPs in ensuring and reporting optimal health outcomes among their clients served.

The ADAPs with viral load suppression rates in excess of 90% in CY2021 include Arizona (95%), Florida (91%), Illinois (94%), Iowa (90%), Michigan (91%), Montana (92%), New Mexico (95%), Ohio (94%), Vermont (96%), and Washington State (91%).

These data illustrate that ADAPs EHE, can make meaningful contributions toward widespread viral suppression and, by extension, the EHE initiative.

Dynamic Program Expenditures in a Dynamic HIV Care Environment

One of the more notable findings reported in the 2021–2022 National RWHAP Part B and ADAP Monitoring Project Report involved a significant increase in ADAP program expenditures from CY2019 to CY2020, totaling $2.22 and $2.43 billion across 47 and 45 jurisdictions providing expenditure data, respectively. Limiting the comparison to jurisdictions providing expenditure data for both years, CY2020 ADAP program expenditures were approximately 10% higher than those reported in CY2019. 

A significant increase in prescription drug expenditures, potentially owing to an increased number of prescription drug fills (including 60- and 90-day fills in support of COVID-19 precautions), was identified as a contributor to the significant increase in overall ADAP program expenditures between the two years.

ADAP program expenditure data for CY2021 totaled $2.12 billion. Limiting the comparisons to 43 jurisdictions providing expenditure data in CY2020 and CY2021, expenditures totaled 2.31 billion and $2.09 billion respectively, indicating a 11% decrease in program expenditures between the two years. A corresponding 18% decrease in prescription drug expenditures was also observed.

For CY2019, five ADAP programs reported implementing cost-containment measures. Five jurisdictions either continued cost-containment measures implemented in CY2019 or implemented new cost-containment measures in CY2020. In CY2021, eight jurisdictions, including four jurisdictions that hadn’t implemented cost-containment measures in the two years prior, either continued or implemented cost-containment measures. Most programs reported limiting the number of Marketplace or off-Marketplace plans available for premium payment support under their ADAP-funded insurance programs. Two programs reported restricting their formularies, including one ADAP’s decision not to add a new ARV product to its formulary. One reported reassigning or reducing staff who were previously funded with ADAP rebate dollars.

Whether overall or program-level expenditure changes, or the implementation of cost-containment measures, are associated with EHE activities or the impact of COVID-19 on program utilization cannot be determined from the data provided.

Footnotes

²Clients “served with full-pay medications" include clients served by the full-pay prescription program for the entire year (or the entirety of a partial year enrolled in the program), with no ADAP coordination with insurance.

³Clients “served through an ADAP funded insurance program” includes clients who were enrolled in insurance (i.e., Medicare, Medicaid, private insurance) at any point during the year and for whom payment for premiums and/or cost-sharing was made on their behalf using ADAP funds. Cost-sharing includes any copayments, coinsurance, and/or deductible payments required under the client’s insurance plan or program.

⁴Clients “served through full-pay medications and an ADAP funded insurance program” includes clients who either spent part of the year in one program and part of the year in the other or they were primarily served by the ADAP-funded insurance program but required full-pay medication program coverage of medications not covered by their insurance.

⁵Survey respondents provide aggregate race and ethnicity data. Without client-level data, the National RWHAP Part B ADAP Monitoring Project Annual Report is unable to provide breakdowns of intersecting race and ethnicity categories (e.g., number of non-Hispanic Black ADAP clients served).