Insurance coverage and financing landscape for HIV treatment and prevention in the USA.

In 2010, the US health insurance system underwent one of its most substantial transformations with the passage of the Affordable Care Act, which increased coverage for millions of people in the USA, including those with and at risk of HIV. Even so, the system of HIV care and prevention services in the USA is a complex patchwork of payers, providers, and financing mechanisms. People with HIV are primarily covered by Medicaid, Medicare, private insurance, or a combination of these; many get care through other programmes, particularly the Ryan White HIV/AIDS Program, which serves as the nation's safety net for people with HIV who remain uninsured or underinsured but offers modest to no support for prevention services. While uninsurance has drastically declined over the past decade, the USA trails other high-income countries in key HIV-specific metrics, including rates of viral suppression. In this paper in the Series, we provide an overview of the coverage and financing landscape for HIV treatment and prevention in the USA, discuss how the Affordable Care Act has changed the domestic health-care system, examine the major programmes that provide coverage and services, and identify remaining challenges.

Comparative Pricing of Branded Tenofovir Alafenamide-Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate-Emtricitabine for HIV Preexposure Prophylaxis: A Cost-Effectiveness Analysis.

Background: Tenofovir alafenamide-emtricitabine (F/TAF) was recently approved as a noninferior and potentially safer option than tenofovir disoproxil fumarate-emtricitabine (F/TDF) for HIV preexposure prophylaxis (PrEP) in the United States. Objective: To estimate the greatest possible clinical benefits and economic savings attributable to the improved safety profile of F/TAF and the maximum price payers should be willing to pay for F/TAF over generic F/TDF. Design: Cost-effectiveness analysis. Data Sources: Published literature on F/TDF safety (in persons with and those without HIV) and the cost and quality-of-life effects of fractures and end-stage renal disease (ESRD). Target Population: Age-stratified U.S. men who have sex with men (MSM) using PrEP. Time Horizon: Five years. Perspective: Health care sector. Intervention: Preexposure prophylaxis with F/TAF versus F/TDF. Outcome Measures: Fractures averted, cases of ESRD averted, quality-adjusted life-years (QALYs) saved, costs, incremental cost-effectiveness ratios (ICERs), and maximum justifiable price for F/TAF compared with generic F/TDF. Results of Base-Case Analysis: Over a 5-year horizon, compared with F/TDF, F/TAF averted 2101 fractures and 25 cases of ESRD for the 123 610 MSM receiving PrEP, with an ICER of more than $7 million per QALY. At a 50% discount for generic F/TDF ($8300 per year) and a societal willingness to pay up to $100 000 per QALY, the maximum fair price for F/TAF was $8670 per year. Results of Sensitivity Analysis: Among persons older than 55 years, the ICER for F/TAF remained more than $3 million per QALY and the maximum permissible fair price for F/TAF was $8970 per year. Results were robust to alternative time horizons and PrEP-using population sizes. Limitation: Intermittent use and on-demand PrEP were not considered. Conclusion: In the presence of a generic F/TDF alternative, the improved safety of F/TAF is worth no more than an additional $370 per person per year. Primary Funding Source: National Institute of Allergy and Infectious Diseases, National Institute on Drug Abuse, National Institute of Mental Health, and Massachusetts General Hospital Executive Committee on Research.

The Epi-TAF for Tenofovir Disoproxil Fumarate?

Approximately 84% of human immunodeficiency virus (HIV)-infected US residents on antiretroviral therapy currently receive some form of tenofovir disoproxil fumarate (TDF) as part of their HIV treatment regimen. The TDF analogue tenofovir alafenamide (TAF) has demonstrated equal efficacy but with decreased renal injury and bone mineral density loss compared with TDF. We examine how much more society ought to be willing to pay for TAF over TDF, in exchange for its improved toxicity profile. Using cost-effectiveness methods, we find that current conditions warrant an annual premium of up to $1000 over the average wholesale price (AWP) of TDF. Once generic coformulations of tenofovir/lamivudine become accessible, however, the appropriate premium for TAF will likely merit a downward adjustment, using generic TDF-based costs as the benchmark.

The state of engagement in HIV care in the United States: from cascade to continuum to control.

The National HIV/AIDS Strategy and the promise of treatment as prevention have garnered considerable attention from the policy, practice, and scientific communities, with the treatment cascade becoming the sentinel image illustrating the domestic human immunodeficiency virus (HIV) epidemic. The cascade depicts prevalence estimates for sequential steps from HIV diagnosis through viral suppression, the most striking of which is that >50% of persons diagnosed with HIV are not in medical care. This heterogeneous group includes individuals not linked to medical care following HIV diagnosis and those entering care who are not retained, requiring reengagement from a range of community settings. This review synthesizes the state of engagement in HIV care in the United States, focusing on research, practice, and policy considerations. Included are conceptual frameworks, a review of health implications, measurement, monitoring, and evidence-based intervention approaches, and a look to the future in addressing the greatest challenge and opportunity facing our domestic HIV epidemic.

Guidelines for improving entry into and retention in care and antiretroviral adherence for persons with HIV: evidence-based recommendations from an International Association of Physicians in AIDS Care panel.

DESCRIPTION: After HIV diagnosis, timely entry into HIV medical care and retention in that care are essential to the provision of effective antiretroviral therapy (ART). Adherence to ART is among the key determinants of successful HIV treatment outcome and is essential to minimize the emergence of drug resistance. The International Association of Physicians in AIDS Care convened a panel to develop evidence-based recommendations to optimize entry into and retention in care and ART adherence for people with HIV. METHODS: A systematic literature search was conducted to produce an evidence base restricted to randomized, controlled trials and observational studies with comparators that had at least 1 measured biological or behavioral end point. A total of 325 studies met the criteria. Two reviewers independently extracted and coded data from each study using a standardized data extraction form. Panel members drafted recommendations based on the body of evidence for each method or intervention and then graded the overall quality of the body of evidence and the strength for each recommendation. RECOMMENDATIONS: Recommendations are provided for monitoring entry into and retention in care, interventions to improve entry and retention, and monitoring of and interventions to improve ART adherence. Recommendations cover ART strategies, adherence tools, education and counseling, and health system and service delivery interventions. In addition, they cover specific issues pertaining to pregnant women, incarcerated individuals, homeless and marginally housed individuals, and children and adolescents, as well as substance use and mental health disorders. Recommendations for future research in all areas are also provided.

Access to a novel first-line single-tablet HIV antiretroviral regimen in Affordable Care Act Marketplace plans, 2018-2020.

BACKGROUND: A pillar of the United States' Ending the HIV Epidemic (EHE) initiative is to rapidly provide antiretroviral therapy (ART) in order to achieve HIV viral suppression. However, insurance benefit design can impede ART access. The primary objective of this study is to understand how Affordable Care Act (ACA) Marketplace qualified health plan (QHP) formularies responded to two new ART single tablet regimens (STRs): dolutegravir/abacavir/lamivudine (DTG/ABC/3TC; approved in 2014) and bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF; approved in 2018). METHODS: We conducted a descriptive study of individual and small group QHPs to assess coverage, cost sharing (coinsurance vs. copay), specialty tiering, prior authorization, and out-of-pocket (OOP) costs for DTG/ABC/3TC and BIC/FTC/TAF. All individual and small group QHPs offered in state ACA Marketplaces from 2018-2020 were identified using plan-level formulary data from Ideon linked to end-of-year data from Robert Wood Johnson Foundation's Individual Market Health Insurance Exchange (HIX). RESULTS: For 2018, 2019, and 2020, respectively, we identified 19,533, 17,007, and 21,547 QHPs. While DTG/ABC/3TC coverage was above 91% from 2018-2020, BIC/FTC/TAF coverage improved from 60 to 86%. Coverage of BIC/FTC/TAF improved in EHE priority jurisdictions from 73 to 90% driven by increased coverage with coinsurance. Although BIC/FTC/TAF had a higher wholesale acquisition cost than DTG/ABC/3TC, monthly OOP cost trends differed regionally in the Midwest but did not differ by EHE priority jurisdiction status. CONCLUSIONS: QHP coverage of STRs is heterogeneous across the US. While coverage of BIC/FTC/TAF increased over time, many QHPs in EHE priority jurisdictions required coinsurance. Access to new ART regimens may be slowed by delayed QHP coverage and benefit design.

Ryan White HIV/AIDS Part B and AIDS Drug Assistance Programs during COVID-19: safety net public health programs' challenges and innovations.

Introduction: We characterized the challenges and innovations of states' Ryan White HIV/AIDS Program (RWHAP) Part B programs, including AIDS Drug Assistance Programs (ADAPs), during the COVID-19 pandemic. In the United States, these are important safety net programs for HIV healthcare, providing essential medical and support services, and medications, to people with HIV with low incomes who are uninsured/underinsured. Methods: Data were collected via the 2021-2022 NASTAD National RWHAP Part B and ADAP Monitoring Project Report, a cross-sectional survey of state, district, and territorial programs through a mixed method study design. For quantitative data, we used descriptive statistics. Qualitative responses were coded and analyzed using content analysis. Results: Forty-seven RWHAP Part B and ADAPs responded (92% response rate). The majority of respondents reported that maintaining client eligibility (78%) and working remotely (70%) were the most challenging aspects of the pandemic, particularly in regards to implementing new telehealth and e-certification platforms. In response to COVID-19, programs introduced enrollment "grace periods" (19%), bolstered client outreach (11%), allowed more than a 30 day supply of medications (79%), and supported medication home delivery for clients (80%). Discussion: Despite the challenges of the COVID-19 pandemic, RWHAP Part B and ADAPs implemented several operational innovations in order to continue providing essential medicines and services. Other public health programs may adopt similar innovations, including digital innovations, for greater public health benefit. Future studies should assess the retention of policy innovations over time, their impact on the individual client level satisfaction or health outcomes, and what factors may improve the acceptability of telehealth and e-certification platforms.

Economic benefits of the United States' AIDS drug assistance Program: A systematic review of cost analyses to guide research and policy priorities.

As part of the Ryan White HIV/AIDs Program, the federally-funded, state-administered AIDS Drug Assistance Program (ADAP) provides prescription drug medications, including antiretroviral therapy, for people with HIV (PWH) who are uninsured/underinsured and have a low income. ADAP expenditures are ∼$2.4 billion annually, but there is a dearth of formal economic analysis supporting the societal perspective. We conducted a systematic review of economic analyses of the United States' AIDS Drug Assistance Program to establish future research priorities based on gaps in knowledge. We searched six electronic databases for articles published before January 2022 that met inclusion criteria. We used the 2022 Consolidated Health Economic Evaluation Reporting Standards to assess the quality of reporting of the economic evaluations. We extracted data into categories to assess gaps and needs for future economic evaluation. Seven studies met inclusion criteria. Two used the same modeling approaches but were published with slightly different outcomes. The few economic analyses that focused solely on ADAP were conducted using 2008 or older data. The most recent study modeled the net cost per quality-adjusted life-year (QALY) secondary to reducing new HIV cases among those virally suppressed, but did not include the economic or health benefits for PWH. ADAP programs' delivery of antiretroviral therapy has shifted from primarily direct provision to subsidizing insurance plans. None of the models take these shifts into account. Updated person-centered cost effectiveness models assessing ADAP are needed on a national and state-by-state level to guide policy decisions and coverage determinations.

Financing and Delivering Pre-Exposure Prophylaxis (PrEP) to End the HIV Epidemic.

The U.S. has the tools to end the HIV epidemic, but progress has stagnated. A major gap in U.S. efforts to address HIV is the under-utilization of medications that can virtually eliminate acquisition of the virus, known as pre-exposure prophylaxis (PrEP). This document proposes a financing and delivery system to unlock broad access to PrEP for those most vulnerable to HIV acquisition and bring an end to the HIV epidemic.

Worsening Disparities in State-Level Uptake of Human Immunodeficiency Virus Preexposure Prophylaxis, 2014-2018.

Retrospective analysis of human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) use among individuals with PrEP indications demonstrates worsening disparities in uptake between early- and late-adopting states from 2014 to 2018. To end the HIV epidemic, federal and state governments must close gaps by translating successful policies from early-adopting states to late-adopting states.

Advocacy for Gender Affirming Care: Learning from the Injectable Estrogen Shortage.

Hormone therapy is medically necessary for many transgender individuals. The U.S. Food and Drug Administration (FDA) and pharmaceutical companies' failure to guarantee a supply of injectable estrogen in 2016 and 2017 for transgender individuals is a violation of their right to comprehensive medical treatment, free of discrimination. A series of advocacy actions eventually led to all formulations of injectable estrogen being restored to market; however, long-term solutions to supply interruptions of injectable estrogen are needed. Long-term solutions should address the lack of federally funded research and, consequently, evidence-based practice on hormone therapy for gender affirmation.

Trauma and Growth: Impact of AIDS Activism.

INTRODUCTION: Our goal was to assess the long-term impact of AIDS activism of ACT UP/New York on the current adjustment of those who were members during its peak years (1987-1992), including assessment of trauma sequelae as well as posttraumatic growth. METHODS: A 90-minute semistructured interview and 6 validated self-report scales were administered. We relied on purposive and snowball sampling to recruit potential participants. Areas covered include demographics, ACT UP participation, and psychiatric problems. Self-report scales provided approximate diagnoses of PTSD and depression, as well as coping, optimism, and related concepts. RESULTS: Participants included 102 men (40% HIV-positive) and 23 women. Seventeen percent reported current symptoms suggesting PTSD, slightly above the range in general population studies. Symptoms consistent with depression were reported by 8% overall, with higher rates for HIV+ men. Enhanced sense of self, belief in change, and empowerment were reported by 93% of respondents, independent of concurrent PTSD or depression. CONCLUSIONS: Twenty-eight years later, ACT UP study participants recall their activist days during the AIDS epidemic as the peak experience of their lives. While some continue to have symptoms of stress and depression, most found that their activism has enriched their subsequent lives.

Towards an integrated primary and secondary HIV prevention continuum for the United States: a cyclical process model.

INTRODUCTION: Every new HIV infection is preventable and every HIV-related death is avoidable. As many jurisdictions around the world endeavour to end HIV as an epidemic, missed HIV prevention and treatment opportunities must be regarded as public health emergencies, and efforts to quickly fill gaps in service provision for all people living with and vulnerable to HIV infection must be prioritized. DISCUSSION: We present a novel, comprehensive, primary and secondary HIV prevention continuum model for the United States as a conceptual framework to identify key steps in reducing HIV incidence and improving health outcomes among those vulnerable to, as well as those living with, HIV infection. We further discuss potential approaches to address gaps in data required for programme planning, implementation and evaluation across the elements of the HIV prevention continuum. CONCLUSIONS: Our model conceptualizes opportunities to monitor and quantify primary HIV prevention efforts and, importantly, illustrates the interplay between an outcomes-oriented primary HIV prevention process and the HIV care continuum to move aggressively forward in reaching ambitious reductions in HIV incidence. To optimize the utility of this outcomes-oriented HIV prevention continuum, a key gap to be addressed includes the creation and increased coordination of data relevant to HIV prevention across sectors.