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Purpose of Review: Injectable cabotegravir for HIV preexposure prophylaxis (PrEP) is effective, yet global implementation has been slow. We review factors which have contributed to the delayed roll-out of this medication., Recent Findings: Fifty-three countries have approved cabotegravir for HIV prevention yet roll-out has been slow. Cabotegravir made up 2.5% of all U.S. PrEP prescriptions in 2023 and is very slowly increasing after FDA approval in 2021. Medication has not been available outside of implementation science studies in Africa and Asia. There is a lengthy process for generic medication production despite agreements signed in 2021; the first available generic dose is not anticipated until 2027. In the United States, where some of the cabotegravir medication costs can be covered under individual insurance plans, high costs and medication acquisition pathways for health centers have been complex, contributing to national implementation delays. The intensity of the staffing required for medication acquisition, insurance paperwork filing, process documentation, billing, injection administration, appointment scheduling, missed appointment monitoring and client follow up has burdened healthcare organizations., Summary: Injectable cabotegravir PrEP has not reaped its potential to be an alternative in those for whom adherence to a daily PrEP pill is challenging. Lessons learned regarding cabotegravir medication acquisition pathways and clinical delivery strategies can inform the rollout of future HIV prevention long-acting agents., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Gay, bisexual, and other men who have sex with men (GBMSM) account for the highest proportion of HIV diagnoses in the United States, with daily pre-exposure prophylaxis (PrEP) significantly reducing transmission risk. Since 2021, the Affordable Care Act rules have required PrEP and accompanying care visits to be free for most Americans; nevertheless, insurers have found ways to circumvent no-cost PrEP and some employers are receiving exemptions from including it in their formularies. Despite this, perceived costs and indirect expenses still hinder PrEP adoption. This study examines the differences between perceived and actual costs among GBMSM who have and have not used PrEP. We conducted a one-time online survey with 692 adults from six New England states between May 2020 and October 2021. Participants who had never used PrEP estimated its cost, while those with prior PrEP experience reported their actual expenses. Bivariate analysis and multi-variable logistic regression were used to assess the data. Results showed a 60% difference between perceived ($48) and actual ($30) median monthly costs. Higher perceived costs among nonusers were linked to race and income, while high actual costs for prior users were associated with insurance type, income, wealth, race, and self-rated consumer credit. This significant disparity in PrEP cost perceptions highlights the need for targeted outreach and messaging to improve PrEP uptake among at-risk populations who have not yet accessed it.

Background: Heavily treatment-experienced (HTE) people with HIV (PWH) have limited treatment options owing to multidrug resistance (MDR). Lenacapavir (LEN) is indicated, in combination with other antiretrovirals, for the treatment of adults with MDR HIV-1 experiencing failure of their current antiretroviral regimen because of resistance, intolerance, or safety considerations., Objective: To evaluate the cost-utility of LEN in combination with an optimized background regimen (OBR) vs alternative recently approved treatments for HTE PWH, fostemsavir (FTR)+OBR and ibalizumab (IBA)+OBR, for the treatment of PWH with MDR, from a mixed US health care payer perspective., Methods: A Markov state-transition model with a lifetime time horizon was developed. Transition probabilities between viral load categories were based on individual participant data from the CAPELLA trial for LEN+OBR and on relative efficacy parameters obtained from indirect treatment comparisons for comparators. Health state utilities were sourced from the literature. Costs included drug acquisition costs, drug administration costs, disease management costs, adverse event costs, AIDS-related event costs, and treatment switching costs and were sourced from red book costs, Medicare and Medicaid fees, and the literature. Costs and outcomes were discounted at 3% annually. The model was used to estimate total and incremental costs, life-years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. A deterministic and a probabilistic sensitivity analysis, as well as scenario analyses, were performed to address elements of uncertainty in the model and to explore the robustness of the results., Results: Over a lifetime time horizon, LEN+OBR was associated with the highest absolute QALYs (9.41) and the greatest number of LYs (12.09) compared with FTR+OBR (QALYs: 8.75; LYs: 11.26) and IBA+OBR (QALYs: 8.36; LYs: 10.78). LEN+OBR was also associated with the lowest total lifetime costs of the 3 interventions (LEN+OBR: $1,441,122 [US dollars]; FTR+OBR: $1,504,986; IBA+OBR: $1,524,396) and therefore was dominant over both comparators in the base case. LEN+OBR remained dominant vs FTR+OBR and IBA+OBR across the range of scenarios tested and LEN+OBR had a 99% probability of being cost-effective compared with FTR+OBR and IBA+OBR in the probabilistic sensitivity analysis at a willingness-to-pay threshold of $50,000/QALY., Conclusions: This economic evaluation demonstrated that LEN+OBR provides meaningful increases in QALYs and LYs, and is dominant over a lifetime time horizon, compared with FTR+OBR and IBA+OBR for the treatment of PWH with MDR in the United States.

Background: Use of HIV preexposure prophylaxis (PrEP) has increased nationwide, but the magnitude and distribution of PrEP medication costs across the health care system are unknown., Objective: To estimate out-of-pocket (OOP) and third-party payments using a large pharmacy database., Design: Retrospective cohort study., Setting: Prescriptions for tenofovir disoproxil fumarate with emtricitabine (TDF-FTC) for PrEP in the United States in the IQVIA Longitudinal Prescriptions database, which covers more than 90% of retail pharmacy prescriptions., Measurements: Third-party, OOP, and total payments were compared by third-party payer, classified as commercial, Medicaid, Medicare, manufacturer assistance program, or other. Missing payment data were imputed using a generalized linear model to estimate overall PrEP medication payments., Results: Annual PrEP prescriptions increased from 73 739 to 1 100 684 during 2014 to 2018. Over that period, the average total payment for 30 TDF-FTC tablets increased from $1350 to $1638 (5.0% compound annual growth rate) and the average OOP payment increased from $54 to $94 (14.9% compound annual growth rate). Of the $1638 in total payments per 30 TDF-FTC tablets in 2018, OOP payments accounted for $94 (5.7%) and third-party payments for $1544 (94.3%). Out-of-pocket payments per 30 tablets were lower among Medicaid recipients ($3) than among those with Medicare ($80) or commercial insurance ($107). Payments for PrEP medication in the IQVIA database in 2018 totaled $2.08 billion; $1.68 billion (80.7%) originated from prescriptions for persons with commercial insurance, $200 million (9.6%) for those with Medicaid, $48 million (2.3%) for those with Medicare, and $127 million (6.1%) for those with manufacturer assistance., Limitation: The IQVIA database does not capture every prescription nationwide., Conclusion: Third-party and OOP payments per 30 TDF-FTC tablets increased annually. The $2.08 billion in PrEP medication payments in 2018 is an underestimation of national costs. High costs to the health care system may hinder PrEP expansion., Primary Funding Source: Centers for Disease Control and Prevention.

Strong measures are needed to increase access to and education about PrEP.

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.

Background: Two-drug regimens (2DR) to treat HIV infection have the potential to reduce long-term toxicity and increase therapeutic options for people living with HIV (PLHIV). Prior phase III trials, SWORD-1 and SWORD-2, as well as GEMINI-1 and GEMINI-2, have demonstrated that a dolutegravir-based 2DR is as effective as three- or four-drug regimens among virologically suppressed patients. Limited information exists, however, on patient and provider experiences with 2DR to inform roll-out and integration into routine clinical care., Methods: We conducted 39 in-depth interviews with PLHIV currently on 2DR in the context of routine care and 8 of their clinical care providers in the United States (U.S.) and Spain. Participants included 33 male and 6 female PLHIV and 8 providers. Interview topics explored perceptions of and experiences with 2DR compared to prior anti-retroviral regimens (ARVs), side effects, patient satisfaction, and clinical performance. Interviews were audio-recorded, transcribed and analyzed using thematic content analysis., Results: Participants viewed 2DR as a significant and positive advance, in terms of its ability to effectively treat HIV with reduced toxicity and essentially no reported side effects. Patients noted the central role providers played in the decision to switch to a 2DR regimen and, among U.S. participants, the importance of insurance coverage making this preferred option feasible. Patients and providers agreed that a 2DR regimen would be appropriate for any PLHIV regardless of whether they were treatment naïve or had significant experience with ARVs., Conclusions: Participants' experiences with a 2DR regimen were positive with no participants, reporting side effects and all reporting continued viral suppression. Providers valued the reduced toxicity offered by 2DR and served as the primary gateway to a transition to 2DR for patients in both settings. This study provides a foundation for further research on the transition to 2DR regimens in other populations and contexts including low- and middle-income settings., Competing Interests: Authors WD, AM, TK, and DK received support for this study via a ViiV Healthcare contract; authors UFB, SM, SM, HK, AC were investigators on trials supported in part by ViiV Healthcare; author YP is an employee of ViiV Healthcare and author MM was an employee of ViiV Healthcare at the time of this research. This does not alter our adherence to PLOS ONE policies on sharing data and materials. There are no patents, products in development or marketed products to declare.

Background: In 2015, there were approximately 40,000 new HIV diagnoses in the United States. Pre-exposure prophylaxis (PrEP) is an effective strategy that reduces the risk of HIV acquisition; however, uptake among those who can benefit from it has lagged. In this study, we 1) compared the characteristics of patients who were prescribed PrEP with individuals newly diagnosed with HIV infection, 2) identified the specialties of practitioners prescribing PrEP, 3) identified metropolitan statistical areas (MSAs) within the US where there is relatively low uptake of PrEP, and 4) reported median amounts paid by patients and third-party payors for PrEP., Methods and Findings: We analyzed prescription drug claims for individuals prescribed PrEP in the Integrated Dataverse (IDV) from Symphony Health for the period of September 2015 to August 2016 to describe PrEP patients, prescribers, relative uptake, and payment methods in the US. Data were available for 75,839 individuals prescribed PrEP, and findings were extrapolated to approximately 101,000 individuals, which is less than 10% of the 1.1 million adults for whom PrEP was indicated. Compared to individuals with newly diagnosed HIV infection, PrEP patients were more likely to be non-Hispanic white (45% versus 26.2%), older (25% versus 19% at ages 35-44), male (94% versus 81%), and not reside in the South (30% versus 52% reside in the South).Using a ratio of the number of PrEP patients within an MSA to the number of newly diagnosed individuals with HIV infection, we found MSAs with relatively low uptake of PrEP were concentrated in the South. Of the approximately 24,000 providers who prescribed PrEP, two-thirds reported primary care as their specialty. Compared to the types of payment methods that people living with diagnosed HIV (PLWH) used to pay for their antiretroviral treatment in 2015 to 2016 reported in the Centers for Disease Control and Prevention (CDC) HIV Surveillance Special Report, PrEP patients were more likely to have used commercial health insurance (80% versus 35%) and less likely to have used public healthcare coverage or a publicly sponsored assistance program to pay for PrEP (12% versus 45% for Medicaid). Third-party payors covered 95% of the costs of PrEP. Overall, we estimated the median annual per patient out-of-pocket spending on PrEP was approximately US$72. Limitations of this study include missing information on prescription claims of patients not included in the database, and for those included, some patients were missing information on patient diagnosis, race/ethnicity, educational attainment, and income (34%-36%)., Conclusions: Our findings indicate that in 2015-2016, many individuals in the US who could benefit from being on PrEP were not receiving this HIV prevention medication, and those prescribed PrEP had a significantly different distribution of characteristics from the broader population that is at risk for acquiring HIV. PrEP patients were more likely to pay for PrEP using commercial or private insurance, whereas PLWH were more likely to pay for their antiretroviral treatment using publicly sponsored programs. Addressing the affordability of PrEP and otherwise promoting its use among those with indications for PrEP represents an important opportunity to help end the HIV epidemic., Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: One co-author, KJM, has declared a competing interest in relation to this manuscript. KJM receives research support from the National Heart, Lung, and Blood Institute (R01HL143421), National Institute on Aging (R01AG060935), and Commonwealth Fund and previously did contract work for the US Department of Health and Human Services.

Background: We projected the clinical outcomes, cost-effectiveness, and budget impact of ibalizumab plus an optimized background regimen (OBR) for people with multidrug-resistant (MDR) HIV in the United States., Methods: Using the Cost-Effectiveness of Preventing AIDS Complications microsimulation model and a health care sector perspective, we compared 2 treatment strategies for MDR HIV: (1) IBA + OBR-ibalizumab plus OBR and (2) OBR-OBR alone. Ibalizumab efficacy and cohort characteristics were from trial data: mean age 49 years, 85% male, and mean CD4 150/µL. Six-month viral suppression was 50% with IBA + OBR and 0% with OBR. The ibalizumab loading dose cost $10,500, and subsequent ibalizumab injections cost $8400/month; OBR cost $4500/month. Incremental cost-effectiveness ratios (ICERs) were calculated using discounted (3%/year) quality-adjusted life years (QALYs) and costs. ICERs ≤$100,000/QALY were considered cost-effective. We performed sensitivity analysis on key parameters and examined budget impact., Results: In the base case, 5-year survival increased from 38% with OBR to 47% with IBA + OBR. Lifetime costs were $301,700/person with OBR and $661,800/person with IBA + OBR; the ICER for IBA + OBR compared with OBR was $260,900/QALY. IBA + OBR was not cost-effective even with 100% efficacy. IBA + OBR became cost-effective at base case efficacy if ibalizumab cost was reduced by ≥88%. For an estimated 12,000 people with MDR HIV in the United States, IBA + OBR increased care costs by $1.8 billion (1.5% of total treatment budget) over 5 years., Conclusions: For people with MDR HIV lacking other treatment options, ibalizumab will substantially increase survival when effective. Although adding ibalizumab to OBR is not cost-effective, the low number of eligible patients in the United States makes the budget impact relatively small.

Background: As life expectancy of patients infected with human immunodeficiency virus (HIV) approaches that of the general population, the composition of HIV management costs is likely to change., Objectives: To (a) review treatment and disease management costs in HIV, including costs of adverse events (AEs) related to antiretroviral therapy (ART) and long-term toxicities, and (b) explore the evolving cost drivers., Methods: A targeted literature review between January 2012 and November 2017 was conducted using PubMed and major conferences. Articles reporting U.S. costs of HIV management, acquired immunodeficiency syndrome (AIDS)-defining events, end of life care, and ART-associated comorbidities such as cardiovascular disease (CVD), chronic kidney disease (CKD), and osteoporosis were included. All costs were inflated to 2017 U.S. dollars. A Markov model-based analysis was conducted to estimate the effect of increased life expectancy on costs associated with HIV treatment and management., Results: 22 studies describing HIV costs in the United States were identified, comprising 16 cost-effectiveness analysis studies, 5 retrospective analyses of health care utilization, and 1 cost analysis in a resource-limited setting. Management costs per patient per month, including routine care costs (on/off ART), non-HIV medication, opportunistic infection prophylaxis, inpatient utilization, outpatient utilization, and emergency department utilization were reported as CD4+ cell-based health state costs ranging from $1,192 for patients with CD4 > 500 cells/mm 3 to $2,873 for patients with CD4 < 50 cells/mm 3 . Event costs for AEs ranged from $0 for headache, pain, vomiting, and lipodystrophy to $31,545 for myocardial infarction. The mean monthly per-patient costs for CVD management, CKD management, and osteoporosis were $5,898, $6,108, and $4,365, respectively. Improvements in life expectancy, approaching that of the general population in 2018, are projected to increase ART-related and AE costs by 35.4% and comorbidity costs by 175.8% compared with estimated costs with HIV life expectancy observed in 1996., Conclusions: This study identified and summarized holistic cost estimates appropriate for use within U.S. HIV cost-effectiveness analyses and demonstrates an increasing contribution of comorbidity outcomes, primarily associated with aging in addition to long-term treatment with ART, not typically evaluated in contemporary HIV cost-effectiveness analyses., Disclosures: This analysis was sponsored by ViiV Healthcare, which had no role in the analyses and interpretation of study results. Ward, Sugrue, Hayward, and McEwan are employees of HEOR Ltd, which received funding from ViiV Healthcare to conduct this study. Anderson is an employee of GlaxoSmithKline and holds shares in the company. Punekar and Oglesby are employees of ViiV Healthcare and hold shares in GlaxoSmithKline. Lopes was employed by ViiV Healthcare at the time of the study and holds shares in GlaxoSmithKline.

Background: New guidelines for the treatment of human immunodeficiency virus (HIV) suggest that morbidity and mortality could be reduced if antiretroviral therapy (ART) was initiated immediately after diagnosis, regardless of CD4 cell count., Objective: To assess real-world time to ART initiation and describe medical, pharmacy, and total health care costs in the 6-, 12-, 24-, and 36-month periods after HIV diagnosis based on time to ART initiation among Medicaid-covered patients., Methods: Multistate Medicaid data (January 2012-March 2017) was used to identify adults with HIV-1 initiating ART ≤ 360 days of initial HIV-1 diagnosis. People living with HIV (PLWH) were sorted into mutually exclusive cohorts based on time from diagnosis to ART initiation (≤ 14 days, > 14 to ≤ 60 days, > 60 to ≤ 180 days, and > 180 to ≤ 360 days). ART regimen had to include a protease inhibitor, an integrase strand transfer inhibitor, or a non-nucleoside reverse transcriptase inhibitor, with ≥ 2 nucleoside reverse transcriptase inhibitors. Medical, pharmacy, and total health care costs in the 6, 12, 24, and 36 months following HIV diagnosis were stratified by timeliness of ART initiation., Results: Of 974 patients, 347 (35.6%) initiated ART > 360 days after diagnosis and were excluded. Among the remaining 627 eligible patients, mean age was 39.9 years, 42.7% were female, and 53.9% were black. Among them, 128 (20.4%) were treated ≤ 14 days, 228 (36.4%) between > 14 and ≤ 60 days, 163 (26.0%) between > 60 and ≤ 180 days, and 108 (17.2%) between > 180 and ≤ 360 days. Among patients treated ≤ 180 days, 4.6% had ≥ 1 opportunistic infection in the 6-month period before ART initiation; this proportion reached 5.6% for patients treated >180 and ≤ 360 days. Over the 6-, 12-, 24-, and 36-month periods after diagnosis, per-patient-per-month (PPPM) medical costs were lower for patients who initiated ART ≤ 14 days than for those who initiated > 180 and ≤ 360 days after diagnosis (6 months: $1,611 [≤ 14 days] vs. $3,008 [> 180 and ≤ 360 days]; 12 months: $1,188 vs. $2,110; 24 months: $754 vs. $1,368; 36 months: $651 vs. $1,196). Over the same periods, medical costs generally accounted for > 50% of total health care costs for patients who initiated ART between > 60 and ≤ 180 days and > 180 and ≤ 360 days and for 30%-40% of total health care costs for patients treated ≤ 14 days and between > 14 and ≤ 60 days. Total PPPM health care costs increased with delay of ART initiation in the 36-month period after diagnosis ($2,058 [treated ≤ 14 days] vs. $2,310 [treated between > 180 and ≤ 360 days])., Conclusions: In this study from 2012 to 2017 of Medicaid PLWH treated with ART, 20.4% initiated ART ≤14 days of HIV diagnosis. Patients with delayed ART initiation accumulated more total health care costs in the 36-month period after HIV diagnosis than those initiated within 14 days, highlighting the long-term benefit of rapid ART initiation. An important opportunity remains to engage PLWH in care more rapidly., Disclosures: This study was supported by Janssen Scientific Affairs, which was involved in the study design, interpretation of results, manuscript preparation, and publication decisions. Emond, Romdhani, Lefebvre, and Côté-Sergent are employees of Analysis Group, a consulting company that was contracted by Janssen Scientific Affairs to conduct this study and develop the manuscript. Shohoudi was an employee of Analysis Group at the time the study was conducted. Benson, Tandon, Chow, and Dunn are employees and stockholders of Johnson & Johnson. Parts of the material in this study have been presented at the HIV Drug Therapy Meeting; October 28-31, 2018; Glasgow, UK, and the AMCP Annual Meeting; March 25-28, 2019; San Diego, CA.

Clinical trials have demonstrated that preexposure prophylaxis (PrEP) protects against HIV infection; yet, even with its approval by the Food and Drug Administration (FDA) in 2012, less than 10% of eligible users in the United States are currently taking PrEP.While there are multiple factors that influence PrEP uptake and pose barriers to PrEP implementation, here we focus on PrEP's cost in the United States, which, at the current list price of $2000 per month and with high levels of cost sharing, can leave insured users with more than $1000 in out-of-pocket costs every year. We discuss how patient deductibles, monthly premiums, copayments, and coinsurance vary widely and may increase the financial burden. Although drug payment-assistance programs have made PrEP more affordable to uninsured and underinsured users, lack of insurance is a barrier to PrEP accessibility. The FDA approved a generic version in 2017; however, that version has not been distributed to US consumers and may not be more affordable.As other countries begin implementing PrEP programs, the extent of PrEP's availability as a tool in the global fight against HIV remains to be seen.

Many AIDS drug assistance programs (ADAPs) purchased Affordable Care Act (ACA) qualified health plans (QHPs) for low-income people living with HIV. To date, little has been written about this from the client perspective. The study's objective was to gain information about the experience of Virginia ADAP-funded QHP enrollment and the impact of this change. English-speaking clients who were eligible for ADAP-funded QHPs were recruited at three HIV clinics in Virginia. The goal was to enroll ≥5% of those who were eligible for ADAP-funded QHPs in two Virginia Department of Health planning districts. Participants were surveyed about demographic characteristics, and semi-structured interviews were performed. Descriptive analyses were performed for cohort characteristics. Using an open coding strategy, codebooks were generated for the interviews and themes were identified. The cohort ( n  = 53) met our recruitment goal. Two-thirds gained their ACA knowledge at HIV clinics from case managers and social workers. Many barriers to enrollment were identified, including internet access/literacy. Almost 9 out of 10 participants had concerns about privacy, which centered on QHP's mandated use of mail-order pharmacies. Except for medication concerns, most participants had positive perceptions of the impact of QHP enrollment on their health care. HIV clinic case managers and social workers are often the primary source of knowledge for patients about insurance options and their assistance is crucial for QHP enrollment. Our findings indicate that reducing identified barriers and addressing privacy concerns by allowing people to opt out of mail order pharmacies may encourage QHP enrollment.

Depression is common among women with HIV and untreated depression can result in poor quality of life and worsen HIV outcomes. Women with HIV who are dually enrolled in Medicaid and Medicare faced a potential disruption in medication access when Medicare Part D was implemented in 2006. The goal of this study was to estimate the effects of Medicare Part D implementation on antidepressant use, depressive symptoms, and hospitalization in Medicaid-Medicare dual eligible women with HIV. This study used 2003-2008 data from the Women's Interagency HIV Study. The effects of Medicare Part D were estimated using a difference-in-differences approach, adjusting for temporal trends using a matched control group of Medicaid-only enrollees. Before Medicare Part D implementation, dual eligibles differed from Medicaid-only enrollees in antidepressant use and hospitalization, despite having identical prescription drug coverage through Medicaid. For dual enrollees, the transition to Medicare Part D was not associated with changes in antidepressant use, depressive symptoms, or hospitalization. We did not find disruptive effects on antidepressant use and related outcomes among dual eligibles in this study. Stable antidepressant use may be due to better access to medical care for dual eligibles through Medicare both before and after Medicare Part D implementation, which may have eclipsed any effects of the transition. It may also signal that classification of antidepressants as a protected drug class under Medicare Part D was effective in preventing psychiatric medication disruption.

Objective: To evaluate the cost-effectiveness of financial incentives for human immunodeficiency virus (HIV) viral suppression compared to standard of care., Study Design: Mathematical model of 2-year intervention offering financial incentives ($70 quarterly) for viral suppression (<400 copies/ml 3 ) based on the HPTN 065 clinical trial with HIV patients in the Bronx, NY and Washington, D.C., Methods: A disease progression model with HIV transmission risk equations was developed following guidelines from the Second Panel on Cost-Effectiveness in Health and Medicine. We used health care sector and societal perspectives, 3% discount rate, and lifetime horizon. Data sources included trial data (baseline N = 16,208 patients), CDC HIV Surveillance data, and published literature. Outcomes were costs (2017 USD), quality-adjusted life years (QALYs), HIV infections prevented, and incremental cost-effectiveness ratio (ICER)., Results: Financial incentives for viral suppression were estimated to be cost-saving from a societal perspective and cost-effective ($49,877/QALY) from a health care sector perspective. Compared to the standard of care, financial incentives gain 0.06 QALYs and lower discounted lifetime costs by $4210 per patient. The model estimates that incentivized patients transmit 9% fewer infections than the standard-of-care patients. In the sensitivity analysis, ICER 95% credible intervals ranged from cost-saving to $501,610/QALY with 72% of simulations being cost-effective using a $150,000/QALY threshold. Modeling results are limited by uncertainty in efficacy from the clinical trial., Conclusions: Financial incentives, as used in HTPN 065, are estimated to improve quality and length of life, reduce HIV transmissions, and save money from a societal perspective. Financial incentives offer a promising option for enhancing the benefits of medication in the United States., (Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate the association between human immunodeficiency virus (HIV) patients and medical costs (inpatient, outpatient, pharmacy, total) using a national cohort of HIV-infected Veterans and non-HIV matched controls within the Veteran's Affairs (VA) Administration system., Design: This study used claims (January 2000 to December 2016) extracted from the VA Informatics and Computing Infrastructure and VA Health Economics Resource Center. Cases included Veterans with an International Classification of Diseases, Ninth Revision/International Classification of Diseases, Tenth Revision for HIV with at least 1 prescription for a complete antiretroviral therapy regimen (January 2000 to September 2016). Two non-HIV controls were exact matched on race, sex, month, and year of birth. All patients were followed until the earliest of the following: last date of VA activity, death, or December 31, 2016., Results: A total of 79 578 patients (26 526 HIV and 53 052 non-HIV) met all study criteria. The average age was 49.3 years, 38% were black, 32% were white, and 97% were male for both the HIV and control cohorts. Adjusted multivariable logistic regression models demonstrated that HIV was associated with higher odds of incurring a pharmacy cost (odds ratio = 2286.45, 95% confidence interval: 322.79-16 195.82), 4-fold, and 2-fold higher odds of incurring both outpatient and inpatient costs compared to the matched controls, respectively. In adjusted multivariable gamma generalized linear models, HIV-positive patients had an almost 4-fold, 17-fold, and almost 2-fold higher cost than matched controls in total, pharmacy, and outpatient costs, respectively., Conclusions: This study found an association between HIV-positive patients having higher odds of incurring a medical cost as well as higher medical costs compared to non-HIV controls.

The START Study randomly assigned 4685 persons with CD4+ counts >500 to either immediate treatment (2326 persons) or a group (2359) that had treatment delayed until the CD4+ count was <350 or clinical judgment dictated treatment. The average time in the study was three years. The immediate group (IG) had 42 serious clinical events and the delayed group (DG) had 96. Policy considerations for adopting these results should consider the cost of medications for early treatment, which is the purpose of this article. Cost of early treatment was estimated by assuming the delayed treatment group had been treated for the three-year average course of the study. However, 48% of the DG received ART before the study's end, so that portion of the group's time on ART was reduced to 1.5 years. Average wholesale prices in the United States of the five recommended ART regimens were discounted by 50% to reflect actual pricing. An average medication cost for the five regimens of $20,000 per person year was used. The three-year cost was $107,580,000 for the 52% who would have been treated for three years and for the 48% treated for an average of 1.5 years. The cost per clinical event avoided was $1,992,222. Formulae are provided that will allow the reader to adjust these results to reflect local prices and volumes. Additional factors to be considered should include the cost savings from avoiding serious clinical events, reduction in transmission of HIV for those being treated early in the infection and the issues associated with long-term adherence for those receiving ART at >500 CD4 counts.

Objective: The aim of this study was to investigate the value of coformulated Tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) for preexposure prophylaxis (PrEP) for conception in the U.S. and to identify scenarios in which 'Undetectable = Untransmittable' (U = U) may not be adequate, and rather, PrEP or assisted reproduction would improve outcomes., Design: We developed a Markov cohort simulation model to estimate the incremental benefits and cost-effectiveness of PrEP compared with alternative safer conception strategies, including combination antiretroviral therapy (cART) alone for the HIV-infected partner and assisted reproductive technologies. We modelled various scenarios in which HIV RNA suppression in the male partner was less than perfect., Setting: U.S. healthcare sector perspective., Participants: Serodiscordant couples in the U.S. was composed of an HIV-infected male and HIV-uninfected female seeking conception., Intervention: Economic analysis., Main Outcome Measure(s): Cumulative risks of HIV transmission to women and babies, maternal life expectancy, discounted quality-adjusted life years (QALY), discounted lifetime medical costs and incremental cost-effectiveness ratios., Results: cART with condomless intercourse limited to ovulation was the preferred HIV prevention strategy among women seeking to conceive with an HIV-infected partner who is HIV-suppressed. PrEP was not cost-effective for women who had partners who were virologically suppressed. When the probability of male partner HIV suppression was low and we assumed generic pricing of PrEP, PrEP was cost-effective, and sometimes even cost-saving compared with cART alone., Conclusion: From a U.S. healthcare sector perspective, when the male partner was not reliably suppressed, PrEP became economically attractive, and in some cases, cost-saving.

Background: Tenofovir disoproxil fumarate (TDF), a key component in many human immunodeficiency virus (HIV) treatment regimens, is associated with increased renal and bone toxicities. The contributions of such toxicities to treatment costs, as well as the relative differences in treatment costs for various TDF/emtricitabine (FTC) regimens, remains unexplored., Objective: To estimate and compare mean overall and renal- and bone-specific costs, including total, inpatient, outpatient, and pharmacy costs in patients treated with TDF/FTC+efavirenz (EFV) compared with several non-EFV-containing TDF/FTC regimens., Methods: We conducted a national cohort study of treatment-naive HIV-infected U.S. veterans who initiated treatment from 2003 to 2015 with TDF/FTC in combination with EFV, elvitegravir/cobicistat, rilpivirine, or ritonavir-boosted protease inhibitors (atazanavir, darunavir, or lopinavir). Outcomes of interest were quarterly total, inpatient, outpatient, and pharmacy costs using data from the Veterans Health Administration (VHA) electronic medical record and Managerial Cost Accounting System (an activity-based accounting system that allocates VHA expenditures to patient encounters). We controlled for measured confounders using inverse probability of treatment (IPT) weights and assessed differences using standardized mean differences (SMDs). For comparisons where SMDs exceeded 0.1 after IPT weighting, we used the more conservative matching weights in sensitivity analyses. For hypothesis testing, we compared IPT-adjusted differences in quarterly costs between treatment groups using Mann-Whitney U-tests and generalized estimating equation (GEE) regression models., Results: Of 33,048 HIV-positive veterans, 7,222 met eligibility criteria, including 4,172 TDF/FTC + EFV recipients; mean (SD) age of the cohort was 50.0 (10.0) years; 96.7% were male; 60.1% were black; and 30.1% were white. Quarterly periods of exposure to EFV-containing regimens were 22,499 and of exposure to non-EFV-containing regimens were 11,633. After IPT weighting, absolute SMDs were < 0.1 except for a few covariates in the rilpivirine comparison. The per-patient adjusted mean total quarterly costs were $7,145 for EFV versus $8,726 for non-EFV (P < 0.001; Mann-Whitney U-test) and the per-patient adjusted mean difference in total quarterly costs was $1,419 lower for EFV versus all non-EFV combined (P < 0.001; GEE model). Corresponding values for outpatient costs ($2,656 vs. $2,942; P < 0.001; difference, -$254; P = 0.001), inpatient costs ($2,009 vs. $2,614; P < 0.001), radiology costs ($213 vs. $276; P < 0.001), and pharmacy costs ($2,480 vs. $3,170; P < 0.001; difference, -$600; P < 0.001) were all lower for EFV versus all non-EFV combined. Findings based on matching weights were qualitatively similar. Contributions of renal and bone costs to the total costs of treatment were very small, ranging between $52 and $94 per patient per quarter for renal outcomes and between $6 and $114 for bone outcomes., Conclusions: Among 7,222 HIV-treated veterans over an average follow-up of 1.2 years per patient, those patients receiving TDF/FTC + EFV had lower overall health care costs compared with those receiving non-EFV regimens., Disclosures: This study was funded by Bristol-Myers Squibb. Nelson, Ma, Crook, Knippenberg, Nyman, and LaFleur are employees of the University of Utah, which received a grant from Bristol-Myers Squibb to conduct this study. Nyman also discloses honoraria for consulting from Otsuka and for writing a book chapter from Fresenius. La Fleur reports advisory board and consulting fees from Bristol-Myers Squibb outside of this study. Paul and Esker are employees of, and own stock in, Bristol-Myers Squibb.

Background: Adherence to antiretrovirals (ARVs) is critical to achieving durable virologic suppression., Objective: To investigate risk factors of poor adherence and the effect of suboptimal adherence on health care resource utilization (HCRU) and costs in Medicaid patients., Methods: A retrospective longitudinal study was conducted using Medicaid data. Adults (aged ≥ 18 years) with human immunodeficiency virus (HIV)-1 initiating selected ARVs (index date) were identified. Adherence was measured using medication possession ratio (MPR) and proportion of days covered (PDC) at 6 and 12 months post-index. Risk factors of poor adherence (PDC < 80%) were assessed using a logistic regression. HCRU and costs were compared between suboptimal (80% ≤ PDC < 95%) and optimal (PDC ≥ 95%) adherence groups using Poisson and ordinary least square models, respectively., Results: In total, 3,477 patients were identified. Using MPR, 1,282 (39.0%) of the evaluable patients had poor adherence; 667 (20.2%) had suboptimal adherence; and 1,342 (40.8%) had optimal adherence versus 1,342 (51.1%), 509 (19.0%), and 804 (30.0%), respectively, using PDC at 6 months. PDC at 12 months was even lower. Younger age (OR = 1.58; 95% CI = 1.18-2.11; P = 0.002), noncapitated coverage (OR = 1.40; 95% CI = 1.16-1.69; P < 0.001), dual Medicaid/Medicare coverage (OR = 5.98; 95% CI = 4.39-8.16; P < 0.001), no baseline ARV treatment (OR = 1.98; 95% CI = 1.62-2.41; P < 0.001), and baseline asymptomatic HIV (OR = 1.37; 95% CI = 1.13-1.68; P = 0.002) were associated with higher risk of poor adherence. Suboptimal adherence patients had higher total number of days spent in a hospital (incidence rate ratio [IRR] = 1.62; 95% CI = 1.13-2.19; P = 0.008), total number of long-term care admissions (IRR = 3.11; 95% CI = 1.26-7.39; P = 0.008), total medical costs (mean monthly cost difference = $339; 95% CI = $153-$536; P < 0.001), and inpatient costs (mean monthly cost difference = $259; 95% CI = $122-$418; P < 0.001) compared with patients with optimal adherence., Conclusions: Nonadherence to ARVs was observed in 60%-80% of Medicaid patients, depending on the adherence measure used, and was associated with incremental HCRU and costs. Age, insurance type and coverage, previous ARV treatment, and HIV symptoms were predictors of adherence. Treatment options that enhance adherence and prevent developing virologic failure with drug resistance should be considered for HIV patients., Disclosures: This study was supported by Janssen Scientific Affairs, which was involved in the study design, data collection, data analysis, manuscript preparation, and publication decisions. Emond, Lafeuille, Romdhani, and Lefebvre are employees of Analysis Group, a consulting company that received research grants from Janssen Scientific Affairs to conduct this study. Dunn, Woodruff, Pesa, and Tandon are current employees and stockholders of Johnson & Johnson, owner of Janssen Scientific Affairs. Jiao was an employee of Janssen at the time of the study. Emond has received grants from Novartis, Regeneron, Aegerion, Lundbeck, Bristol-Myers Squibb, Bayer, Millennium, Allergan, AbbVie, and GlaxoSmithKline unrelated to this study. Part of the material in this study was presented at the Academy of Managed Care Pharmacy 2017 Annual Meeting; March 27-30, 2017; Denver, CO, and at the 9th International AIDS Society Conference; July 23-26, 2017; Paris, France.

Methods: Ninety-six-week costs for antiretroviral drugs, adverse event management, and HIV care for individuals initiating RAL, ATV/r, or DRV/r as first-line therapy for HIV-1 infection were estimated using an economic model. Efficacy and safety data (mean CD4 cell count changes, discontinuation rates, grade 3/4 adverse event incidence) for each regimen through 96 weeks of treatment were taken from the ACTG 5257 clinical trial. Antiretroviral drug costs for each initial regimen and for each substitution regimen, as used by individuals who discontinued their initial regimen, were based on wholesale acquisition costs. Adverse event management costs and HIV care costs, stratified by CD4 cell count range, were taken from published sources and inflated to 2016 dollars. Scenario and sensitivity analyses were conducted to assess the robustness of the results. Cost outcomes were discounted at an annual rate of 3.0%., Results: Total 96-week costs were $81,231 for RAL, $88,064 for ATV/r, and $87,680 for DRV/r, where differences were primarily due to lower antiretroviral drug costs for RAL than for ATV/r or DRV/r. These results were found to be robust in scenario and sensitivity analyses., Conclusions: Relative to the DRV/r and ATV/r regimens, the RAL regimen had the lowest cost for treatment-naive adults with HIV-1 infection in the United States., Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: Bridgett Goodwin was an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA at the time the work was done. This does not alter our adherence to PLOS ONE policies on sharing data and materials. Ashley Davis and Anita Brogan are employees of RTI Health Solutions, an independent research organization, and maintained independent scientific control over the study design and analyses.

Objectives: To model the impacts of restrictive formulary designs on outcomes for patients with HIV and to demonstrate the costs of restricting access to novel HIV regimens with better safety and efficacy profiles., Study Design: We modified an epidemiological model of HIV incidence, progression, and treatment to simulate the effects of 5 formulary scenarios on patient outcomes in the United States., Methods: Using a cohort of HIV-susceptible individuals, we followed patients through HIV infection, disease progression, and death. Patients transitioned in and out of treatment states once infected. Treatment discontinuation, efficacy, and the rate of adverse events (AEs; renal failure and bone fracture) in each formulary scenario depended on the treatment path and regimens included. Outcomes of interest included all-cause cumulative deaths, annual rates of AEs, and costs associated with treating those AEs., Results: All outcomes of interest were more favorable in less restrictive formulary scenarios that provided fewer barriers to appropriate treatments. By 2025, more restrictive formularies would have resulted in 171,500 more cumulative bone and renal events among treated patients with HIV compared with an open formulary. This corresponds to AE treatment costs of $3.65 billion in more restrictive formularies compared with $1.43 billion in an open formulary. Finally, compared with an open formulary, there would be an additional 16,200 cumulative deaths in more restrictive formularies., Conclusions: Less restrictive formulary designs, which allow patients with HIV to initiate potentially safer and more efficacious regimens based on their proclivity to AEs, yield better outcomes and reduce costs.

Persons diagnosed with HIV but not retained in HIV medical care accounted for the majority of HIV transmissions in 2009 in the United States (US). There is an urgent need to implement and disseminate HIV retention in care programs; however little is known about the costs associated with implementing retention in care programs. We assessed the costs and cost-saving thresholds for seven Retention in Care (RiC) programs implemented in the US using standard methods recommended by the US Panel on Cost-effectiveness in Health and Medicine. Data were gathered from accounting and program implementation records, entered into a standardized RiC economic analysis spreadsheet, and standardized to a 12 month time frame. Total program costs for from the societal perspective ranged from $47,919 to $423,913 per year or $146 to $2,752 per participant. Cost-saving thresholds ranged from 0.13 HIV transmissions averted to 1.18 HIV transmission averted per year. We estimated that these cost-saving thresholds could be achieved through 1 to 16 additional person-years of viral suppression. Across a range of program models, retention in care interventions had highly achievable cost-saving thresholds, suggesting that retention in care programs are a judicious use of resources.

The National HIV/AIDS Strategy (NHAS) originally issued in 2010 targets the reduction of HIV-related health disparities. Hispanic men who have sex with men (MSM) have the third highest burden of incident HIV in the US, but there are no estimates of the unmet HIV service needs for Hispanic MSM. We estimate that of approximately 204,800 Hispanic MSM living with HIV, roughly 46,900 were undiagnosed. 157,900 were diagnosed, and of those, 75,700 were not linked to care and 82,200 were linked. Among diagnosed individuals, 48,800 had undetectable viral loads, and 109,100 had detectable viral loads. An estimated 30,000 of diagnosed Hispanic MSM engage in unprotected, serodiscordant risk behaviors. Total cost to meet service needs and achieve NHAS goals is ~$2.511 billion in 2011 US dollars. Transmission rate modeling suggests this investment would avert 3656 new HIV infections at an economically favorable cost of $61,202 per quality-adjusted life year saved.

Background: Recommended human immunodeficiency virus (HIV) treatment regimens in the United States contain 3 antiretroviral agents, costing >$30 000/person/year. Pilot studies are evaluating the efficacy of dual therapy with dolutegravir (DTG) and lamivudine (3TC). We examined the potential cost-effectiveness and budget impact of DTG + 3TC regimens in the United States., Methods: Using a mathematical model, we projected the clinical and economic outcomes of antiretroviral therapy (ART)-naive patients under 4 strategies: (1) no ART (for modeling comparison); (2) 2-drug: initial regimen of DTG + 3TC; (3) induction-maintenance: 48-week induction regimen of 3 drugs (DTG/abacavir [ABC]/3TC), followed by DTG + 3TC maintenance if virologically suppressed; and (4) standard of care: 3-drug regimen of DTG/ABC/3TC. Strategy-dependent model inputs, varied widely in sensitivity analyses, included 48-week virologic suppression (88%-93%), subsequent virologic failure (0.1%-0.6%/month), and Medicaid-discounted ART costs ($15 200-$39 600/year). A strategy was considered cost-effective if its incremental cost-effectiveness ratio (ICER) was <$100 000/quality-adjusted life-year (QALY)., Results: The 3 ART strategies had the same 5-year survival rates (90%). The ICER was $22 500/QALY for induction-maintenance and >$500 000/QALY for standard of care. Two-drug was the preferred strategy only when DTG + 3TC 48-week virologic suppression rate exceeded 90%. With 50% uptake of either induction-maintenance or 2-drug for ART-naive patients, cost savings totaled $550 million and $800 million, respectively, within 5 years; savings reached >$3 billion if 25% of currently suppressed patients were switched to DTG + 3TC maintenance., Conclusions: Should DTG + 3TC demonstrate high rates of virologic suppression, this regimen will be cost-effective and would save >$500 million in ART costs in the United States over 5 years., (© The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.)

Background: Research is needed to understand the impact of mental health disorders (MHD) on healthcare resource utilization (HCRU) and costs among people with human immunodeficiency virus (PWH)., Objectives: Examine the HCRU and cost burden among treatment-naïve PWH with and without MHD initiating single tablet antiretroviral regimens (STRs) and multi-tablet regimens (MTRs)., Methods: A retrospective database analysis of the US Medicaid population from Anlitiks' All Payor Claims database between 1 January 2016 and 30 June 2023 was conducted. Treatment-naïve MTR-initiators vs STR-initiators (the index was the first prescription fill claim date) with ≥ 12-months pre- and post-index continuous enrollment and no pre-index HIV-2 diagnosis among PWH/MHD and PWH/no-MHD during 1 January 2017-30 June 2022 were selected. Demographics, clinical characteristics, HCRU and costs between MTR-initiators vs STR-initiators among PWH/MHD and PWH/no-MHD were described using Chi-square tests and Wilcoxon rank-sum or t-tests for categorical and continuous variables, as appropriate. HCRU and costs were examined using multivariable logistic and gamma-log link regression models, controlling for potential confounders., Results: MTR-initiators (PWH/MHD: n  = 7,874, PWH/no-MHD: n  = 3,612) vs. STR-initiators (PWH/MHD: 46,024, PWH/no-MHD: 23,452) were significantly younger (PWH/MHD: 43.6 vs. 47.2 years; PWH/no-MHD: 39.2 vs. 43.3 years) and more likely to be female (PWH/MHD: 46.4% vs. 35.7%; PWH/no-MHD: 42.3% vs 29.7%) in both groups (all p -values < 0.05). MTR-initiators vs. STR-initiators had significantly higher rates of inpatient (IP) hospitalizations (PWH/MHD: 28.9% vs. 27.1%; PWH/no-MHD:13.9% vs. 11.9%) and emergency department (ED) visits (PWH/MHD: 53.3% vs. 49.2%; PWH/no-MHD: 35.2% vs. 31.8%) among both those with and without MHD (all p -values < 0.05). MTR-initiators vs. STR-initiators also had significantly higher adjusted all-cause medical costs (PWH/MHD: $60,228 vs $40,634; PWH/no-MHD: $33,623 vs. $17,996) (all p -values < 0.05)., Conclusions: Among PWH/MHD and PWH/no-MHD, MTR-initiators experienced significantly higher HCRU, and 1.5 times greater costs compared to STR-initiators. In both MTR and STR-initiator groups, the PWH/MHD cohort consistently demonstrated a greater HCRU and cost burden than the PWH/no-MHD.

Background: The possibility of incorporating generics into combination antiretroviral therapy and breaking apart once-daily single-tablet regimens (STRs), may result in less efficacious medications and/or more complex regimens with the expectation of marked monetary savings. A modeling approach that assesses the merits of such policies in terms of lifelong costs and health outcomes using adherence and effectiveness data from real-world U.S. settings., Methods: A comprehensive computer-based microsimulation model was developed to assess the lifetime health (life expectancy and quality adjusted life-years--QALYs) and economic outcomes in HIV-1 infected patients initiating STRs compared with multiple-table regimens including generic medications where possible (gMTRs). The STRs considered included tenofovir disoproxil fumarate/emtricitabine and efavirenz or rilpivirine or elvitegravir/cobicistat. gMTRs substitutions included each counterpart to STRs, including generic lamivudine for emtricitabine and generic versus branded efavirenz., Results: Life expectancy is estimated to be 1.301 years higher (discounted 0.619 QALY gain) in HIV-1 patients initiating a single-tablet regimen in comparison to a generic-based multiple-table regimen. STRs were associated with an average increment of $26,547.43 per patient in medication and $1,824.09 in other medical costs due to longer survival which were partially offset by higher inpatients costs ($12,035.61) with gMTRs treatment. Overall, STRs presented incremental lifetime costs of $16,335.91 compared with gMTRs, resulting in an incremental cost-effectiveness ratio of $26,383.82 per QALY gained., Conclusions: STRs continue to represent good value for money under contemporary cost-effectiveness thresholds despite substantial price reductions of generic medications in the U. S.

Objective: To estimate health care costs associated with medical events identified as antiretroviral therapy (ART)-attributable adverse events (AEs)., Methods: During September 2006 to June 2012, adults with ≥1 HIV International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code (042/V08), ≥1 claim for ART prescription (March 2007-June 2011; index date), and continuous health plan enrollment for ≥6 months pre- and ≥12 months postindex were included (IMS' PharMetrics Plus Health Plan Claims Database). Patients with events of interest/ART claim during preindex period or with pregnancy/hepatitis C virus diagnosis/hepatitis B virus/cancer/tuberculosis during the study period were excluded. Postindex medical events were defined as first diagnosis code of event with ART claim ≤60 days prior to start of the event., Results: Differences in median total all-cause health care costs observed for diabetes/insulin resistance management (US$14,547 median all-cause health care costs during time periods identified as diabetes/insulin resistance medical events versus US$11,237 without diabetes/insulin resistance events; P=.0021), lipid disorders (US$12,825 versus US$10,033; P=.0004), and renal disorders (US$1389 versus US$0; P<.0001)., Discussion/conclusion: Health care costs of ART AEs should be key consideration for payers/providers in HIV management., (© The Author(s) 2015.)

Background: Value of Information (VOI) analysis examines whether to acquire information before making a decision. We introduced VOI to the HIV audience, using the example of generic antiretroviral therapy (ART) in the US., Methods and Findings: We used a mathematical model and probabilistic sensitivity analysis (PSA) to generate probability distributions of survival (in quality-adjusted life years, QALYs) and cost for three potential first-line ART regimens: three-pill generic, two-pill generic, and single-pill branded. These served as input for a comparison of two hypothetical two-arm trials: three-pill generic versus single-pill branded; and two-pill generic versus single-pill branded. We modeled pre-trial uncertainty by defining probability distributions around key inputs, including 24-week HIV-RNA suppression and subsequent ART failure. We assumed that, without a trial, patients received the single-pill branded strategy. Post-trial, we assumed that patients received the most cost-effective strategy. For both trials, we quantified the probability of changing to a generic-based regimen upon trial completion and the expected VOI in terms of improved health outcomes and costs. Assuming a willingness to pay (WTP) threshold of $100 000/QALY, the three-pill trial led to more treatment changes (84%) than the two-pill trial (78%). Estimated VOI was $48 000 (three-pill trial) and $35 700 (two-pill trial) per future patient initiating ART., Conclusions: A three-pill trial of generic ART is more likely to lead to post-trial treatment changes and to provide more value than a two-pill trial if policy decisions are based on cost-effectiveness. Value of Information analysis can identify trials likely to confer the greatest impact and value for HIV care.

Positive Charge (PC) is a linkage to HIV care initiative implemented by AIDS United with sites in New York, Chicago, Louisiana, North Carolina, and the San Francisco/Bay Area. This study employed standard methods of cost and threshold analyses, as recommended by the US Panel on Cost-effectiveness in Health and Medicine, to calculate cost-saving and cost effective thresholds of the initiative. The overall societal cost of the linkage to care programs ranged from $48,490 to $370,525. The study found that PC's five unique evidence-based linkage to care programs have relatively low costs per client served and highly achievable cost-saving and cost-effectiveness thresholds. The findings from this study suggest that HIV linkage to care programs have the potential to be a highly productive use of public health resources.

Although the Food and Drug Administration (FDA) approved oral Truvada for pre-exposure prophylaxis (PrEP) for women at risk of HIV infection in the US in July 2012, and the Centers for Disease Control and Prevention (CDC) issued guidance for clinicians to provide PrEP to women "at substantial risk of HIV acquisition" in May 2014, there remain no clinical trial data on efficacy among US women, and there is a dearth of research on knowledge, attitudes, and likelihood of use of PrEP among them. We conducted a qualitative focus group (FG) study with 144 at-risk women in six US cities between July and September 2013, including locations in the Southern US, where HIV infections among women are most prevalent. FG questions elicited awareness of PrEP, attitudes about administration and uptake, and barriers to and facilitators of use. Women expressed anger at the fact that they had not heard of PrEP prior to the study, but once informed most found it attractive. PrEP was seen as additional, not substitute protection to condoms, and participants suggested several dissemination strategies to meet the diverse needs of women. Key barriers to PrEP uptake included distrust of the medical system, stigma, and cost. Findings suggest that US women view PrEP as an important prevention option, assuming side effects and the cost to the consumer are minimal, the efficacy of the drug is reasonable, and PrEP is delivered by trusted providers in trusted venues.

Objective: Data from the SINGLE trial demonstrated that 88% of treatment-naïve HIV-1 patients treated with dolutegravir and abacavir/lamivudine (DTG + ABC/3TC) achieved viral suppression at 48 weeks compared with 81% of patients treated with efavirenz/tenofovir disoproxil fumarate/emtricitabine (EFV/TDF/FTC). It is unclear how this difference in short-term efficacy impacts long-term cost-effectiveness of these regimens. This study sought to evaluate long-term cost-effectiveness of DTG + ABC/3TC vs EFV/TDF/FTC from a US payer perspective., Methods: This study is an individual discrete-event simulation which tracked the disease status and treatment pathway of HIV-1 patients. The model simulated treatment over a lifetime horizon by tracking change in patients' CD4 count, clinical events occurrence (opportunistic infections, cancer, and cardiovascular events), treatment switch, and death. The model included up to four lines of treatment. Baseline patient characteristics, efficacy, and safety of DTG + ABC/3TC and EFV/TDF/FTC were informed by data from the SINGLE trial. The efficacy of subsequent treatment lines, clinical event risks, mortality, cost, and utility inputs were based on literature and expert opinion. Outcomes were lifetime discounted medical costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER)., Results: Compared with EFV/TDF/FTC, DTG + ABC/3TC increased lifetime costs by $19,153 and per person survival by 0.12 QALYs, resulting in an ICER of $158,890/QALY. ICERs comparing DTG + ABC/3TC to EFV/TDF/FTC remained above the traditional, US willingness-to-pay threshold of $50,000/QALY gained in all scenarios, and above $100,000 or $150,000/QALY gained in most scenarios., Limitations: Due to data limitations, the treatment patterns, CD4 count during viral rebound and treatment switch, viral rebound after trial end, and long-term adverse event-related treatment discontinuation were based on assumptions, presented to and approved by clinical experts., Conclusions: Compared with EFV/TDF/FTC, DTG + ABC/3TC resulted in higher cost and only slightly increased QALYs over a lifetime, with an ICER that exceeded the standard cost-effectiveness threshold. This indicates that the incremental benefit in effectiveness associated with DTG + ABC/3TC may not be worth the incremental increase in costs.

In recent years, guidelines for HIV treatment have recommended initiation of combination antiretroviral therapy (cART) earlier in the course of the disease than was previously the case. These recommendations stem in part from growing evidence that treatment reduces the risk of sexual transmission. We used an epidemiological model of disease transmission and progression to assess HIV prevention through early treatment-that is, initiation of cART when CD4 white blood cell counts are in excess of 350 cells per cubic millimeter. (CD4 cells are involved in the immune system's defense against tumors and infection; the number of CD4 cells in a cubic millimeter of blood is a standard measure of immune response to antiretroviral therapy.) We estimated that the actual timing of treatment initiation in the United States prevented 188,000 HIV cases in the period 1996-2009. "Very early" treatment (at CD4 counts greater than 500) accounted for four-fifths of the prevented cases. For all of the prevented cases, the losses in life expectancy that were avoided were worth $128 billion, assuming that a life-year has a value of $150,000. These findings underscore the cost-effectiveness of early HIV treatment.

Background: Antiretroviral therapy (ART) extends life for patients with human immunodeficiency virus (HIV) infection. However, HIV treatment is lifelong, and adherence presents a special challenge. Suboptimal adherence to ART may lead to disease progression and virologic failure. Earlier studies with combination ART demonstrated that as much as 90%-95% adherence was needed to prevent disease progression., Objective: To measure adherence to ART regimens in commercially insured patients with HIV infection and analyze the clinical and demographic factors associated with ≥ 90% adherence., Methods: This study used retrospective claims data from a Mid-Atlantic states MCO. Members 18 years and older with an HIV diagnosis identified by medical claims were included in the cohort, and pharmacy claims were retrieved for these members. An ART regimen was established for each patient within a 120-day period after the last physician's visit occurring between January 1, 2010, and August 31, 2010. For patients who received an ART regimen recommended by the U.S. Department of Health and Human Services (HHS) 2011 Antiretroviral Guidelines, adherence, as measured by medication possession ratio (MPR), was calculated based on pharmacy claims for 12 months after the end of the 120-day period. Logistic regression was used to examine the association between MPR ≥ 90% and age, sex, type of health plan, use of single-tablet regimens (STR), inpatient and outpatient utilization, and direct health care costs., Results: Of the 4,547 adults with HIV diagnosis, 3,528 (77.6%) had received at least 1 antiretroviral. An HHS-recommended ART regimen was identified in 2,377 patients with 1,136 (47.8%) receiving STR. Mean MPR for patients on an HHS-recommended ART regimen was 91.5% ± 14.0 with 73.1% of patients having achieved MPR ≥ 90%. In univariate analyses, sex, number of outpatient visits, cost of inpatient care, and use of STR were significantly associated with MPR ≥ 90%. In multivariate analysis, only male sex (P = 0.027) and the use of STR (P = 0.009) were positively associated with MPR ≥ 90%. Patients on STR were 1.3 times more likely to achieve at least 90% adherence., Conclusions: Adherence is a challenge for patients with HIV, and more than a quarter of patients who were on an HHS-recommended ART regimen failed to achieve an accepted adherence MPR threshold of ≥ 90%. Use of STR was associated with an increased likelihood of achieving adherence of at least 90%. Interventions to improve ART adherence are needed, and STR may be an effective strategy as it decreases pill burden.

We are not aware of published cost-effectiveness studies addressing community transitional programs for HIV-infected jail detainees. To address this gap, data from 9 sites of EnhanceLink, a project that enrolled HIV-infected releasees from jails across the US, were examined. Figures on the number of clients served, cost of linkage services, number of linkages and 6-month sustained linkages to community HIV care, and number of clients achieving viral suppression were assessed for subjects released in the first quarter of 2010 (n = 543). The cost analysis included all costs that participating service agencies incurred. A cost-effectiveness analysis was conducted to estimate the new HIV cases averted by EnhanceLink and the cost per quality-adjusted life year saved by the program. The mean cost per linked client was $4,219; the mean cost per 6-month sustained linkage was $4,670; and the mean cost per client achieving viral suppression was $8,432. Compared to standard care, the cost per additional quality-adjusted life year saved was $72,285, suggesting that the EnhanceLink interventions were cost-effective from the societal perspective.