Life and Disability Insurance for People with or at Risk of HIV: Aligning Policy with Evidence.

Antiretroviral medications have substantially improved life expectancy for people with HIV. These medications are also highly effective in preventing HIV acquisition in people who do not have HIV, a strategy known as HIV preexposure prophylaxis (PrEP). Despite these advances, some life and disability insurers continue to deny or limit coverage for people with HIV, and some have even refused to cover people who are using PrEP to protect themselves. These policies unfairly deny people with HIV, PrEP users, and their families the peace of mind and financial protection that can come with life and disability insurance coverage. This article summarizes the current evidence on HIV treatment and prevention, arguing that underwriting decisions by life and disability insurers should not be made based on HIV status or use of PrEP.

Potential Impact and Cost-Effectiveness of Condomless-Sex-Concentrated PrEP in KwaZulu-Natal Accounting for Drug Resistance.

INTRODUCTION: Oral preexposure prophylaxis (PrEP) in the form of tenofovir-disoproxil-fumarate/emtricitabine is being implemented in selected sites in South Africa. Addressing outstanding questions on PrEP cost-effectiveness can inform further implementation. METHODS: We calibrated an individual-based model to KwaZulu-Natal to predict the impact and cost-effectiveness of PrEP, with use concentrated in periods of condomless sex, accounting for effects on drug resistance. We consider (1) PrEP availability for adolescent girls and young women aged 15-24 years and female sex workers, and (2) availability for everyone aged 15-64 years. Our primary analysis represents a level of PrEP use hypothesized to be attainable by future PrEP programs. RESULTS: In the context of PrEP use in adults aged 15-64 years, there was a predicted 33% reduction in incidence and 36% reduction in women aged 15-24 years. PrEP was cost-effective, including in a range of sensitivity analyses, although with substantially reduced (cost) effectiveness under a policy of ART initiation with efavirenz- rather than dolutegravir-based regimens due to PrEP undermining ART effectiveness by increasing HIV drug resistance. CONCLUSIONS: PrEP use concentrated during time periods of condomless sex has the potential to substantively impact HIV incidence and be cost-effective.

Transporting Subgroup Analyses of Randomized Controlled Trials for Planning Implementation of New Interventions.

Subgroup analyses of randomized controlled trials guide resource allocation and implementation of new interventions by identifying groups of individuals who are likely to benefit most from the intervention. Unfortunately, trial populations are rarely representative of the target populations of public health or clinical interest. Unless the relevant differences between trial and target populations are accounted for, subgroup results from trials might not reflect which groups in the target population will benefit most from the intervention. Transportability provides a rigorous framework for applying results derived in potentially highly selected study populations to external target populations. The method requires that researchers measure and adjust for all variables that 1) modify the effect of interest and 2) differ between the target and trial populations. To date, applications of transportability have focused on the external validity of overall study results and understanding within-trial heterogeneity; however, this approach has not yet been used for subgroup analyses of trials. Through an example from the Iniciativa Profilaxis Pre-Exposición (iPrEx) study (multiple countries, 2007-2010) of preexposure prophylaxis for human immunodeficiency virus, we illustrate how transporting subgroup analyses can produce target-specific subgroup effect estimates and numbers needed to treat. This approach could lead to more tailored and accurate guidance for resource allocation and cost-effectiveness analyses.

Cost-effectiveness of two screening strategies for Chlamydia trachomatis and Neisseria gonorrhoeae as part of the PrEP programme in the Netherlands: a modelling study.

OBJECTIVES: Pre-exposure prophylaxis (PrEP) users are routinely tested four times a year (3 monthly) for asymptomatic Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections on three anatomical locations. Given the high costs of this testing to the PrEP programme, we assessed the impact of 3 monthly screening(current practice), compared with 6 monthly on the disease burden. We quantified the difference in impact of these two testing frequencies on the prevalence of CT and NG among all men who have sex with men (MSM) who are at risk of an STI, and explored the cost-effectiveness of 3-monthly screening compared with a baseline scenario of 6-monthly screening. METHODS: A dynamic infection model was developed to simulate the transmission of CT and NG among sexually active MSM (6500 MSM on PrEP and 29 531 MSM not on PrEP), and the impact of two different test frequencies over a 10-year period. The difference in number of averted infections was used to calculate incremental costs and quality-adjusted life-years (QALY) as well as an incremental cost-effectiveness ratio (ICER) from a societal perspective. RESULTS: Compared with 6-monthly screening, 3-monthly screening of PrEP users for CT and NG cost an additional €46.8 million over a period of 10 years. Both screening frequencies would significantly reduce the prevalence of CT and NG, but 3-monthly screening would avert and extra ~18 250 CT and NG infections compared with 6-monthly screening, resulting in a gain of ~81 QALYs. The corresponding ICER was ~€430 000 per QALY gained, which exceeded the cost-effectiveness threshold of €20 000 per QALY. CONCLUSIONS: Three-monthly screening for CT and NG among MSM on PrEP is not cost-effective compared with 6-monthly screening. The ICER becomes more favourable when a smaller fraction of all MSM at risk for an STI are screened. Reducing the screening frequency could be considered when the PrEP programme is established and the prevalence of CT and NG decline.

Optimal Allocation of Societal HIV Prevention Resources to Reduce HIV Incidence in the United States.

Objectives. To optimize combined public and private spending on HIV prevention to achieve maximum reductions in incidence.Methods. We used a national HIV model to estimate new infections from 2018 to 2027 in the United States. We estimated current spending on HIV screening, interventions that move persons with diagnosed HIV along the HIV care continuum, pre-exposure prophylaxis, and syringe services programs. We compared the current funding allocation with 2 optimal scenarios: (1) a limited-reach scenario with expanded efforts to serve eligible persons and (2) an ideal, unlimited-reach scenario in which all eligible persons could be served.Results. A continuation of the current allocation projects 331 000 new HIV cases over the next 10 years. The limited-reach scenario reduces that number by 69%, and the unlimited reach scenario by 94%. The most efficient funding allocations resulted in prompt diagnosis and sustained viral suppression through improved screening of high-risk persons and treatment adherence support for those infected.Conclusions. Optimal allocations of public and private funds for HIV prevention can achieve substantial reductions in new infections. Achieving reductions of more than 90% under current funding will require that virtually all infected receive sustained treatment.

Health Care Coverage and Preexposure Prophylaxis (PrEP) Use Among Men Who Have Sex With Men Living in 22 US Cities With vs Without Medicaid Expansion, 2017.

Objectives. To compare health care coverage and utilization between men who have sex with men (MSM) in Medicaid expansion versus nonexpansion states.Methods. We used cross-sectional weighted data from the National HIV Behavioral Surveillance system, which used venue-based methods to interview and test MSM in 22 US cities from June through December, 2017 (n = 8857). We compared MSM in Medicaid expansion versus nonexpansion states by using the Rao-Scott χ2 test stratified by HIV status. We used multivariable logistic regression to model the relationship between Medicaid expansion, coverage, and preexposure prophylaxis (PrEP) use.Results. MSM in expansion states were more likely to have insurance (87.9% vs 71.6%), have Medicaid (21.3% vs 3.8%), discuss PrEP with a provider (58.8% vs 44.3%), or use PrEP (31.1% vs 17.5%).Conclusions. Medicaid expansion is associated with higher coverage and care, including PrEP.Public Health Implications. States may consider expanding Medicaid to help end the HIV epidemic.

Cost-Effectiveness Analysis of a National Pre-Exposure Prophylaxis (PrEP) Program in Ireland.

OBJECTIVES: To estimate the cost-effectiveness of introducing a publicly funded pre-exposure prophylaxis (PrEP) program in Ireland. METHODS: We constructed a state-transition Markov model. This was a cross-sectional population model that tracked all HIV-negative men who have sex with men (MSM) in Ireland over their lifetime. Access to a publicly funded PrEP program (medications + frequent monitoring) in high-risk MSM was compared with no PrEP. The primary outcome measure was the incremental cost-effectiveness ratio (ICER). RESULTS: In the base case, introducing a PrEP program was considered cost saving and provided significant health benefits to the population. Univariate sensitivity analysis demonstrated that PrEP efficacy and HIV incidence had the greatest impact on cost-effectiveness. Including an increase in sexually transmitted infections had a negligible impact on the results. Efficacy was a significant driver in the model. PrEP was cost saving at all efficacy values above 60%, and at the lowest reported efficacy in MSM (44% in the iPrEX trial), the ICER was €4711/QALY (highly cost-effective). Event-based dosing (administration during high-risk periods only) was associated with additional cost savings. We estimated that 1705 individuals (95% CI: 617-3452) would join the program in year 1. The incremental budget impact was €1.5m (95% CI: €0.5m to €3m) in the first year and €5.4m over 5 years (95% CI: €1.8m to €11.5m), with 173 cases of HIV averted over 5 years. CONCLUSION: We found that the introduction of a PrEP program would be considered cost saving in the first cost-effectiveness analysis of its kind in Ireland.

HIV Pre-Exposure Prophylaxis, Condoms, or Both? Insights on Risk Compensation Through a Discrete Choice Experiment and Latent Class Analysis Among Men Who Have Sex With Men.

OBJECTIVES: We considered how decision making around human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) among gay, bisexual, and other men who have sex with men (GBMSM) is made in the context of one's perceived risk of HIV acquisition and the availability of condoms. METHODS: We recruited 648 GBMSM aged 18 years old and residing in Singapore through Grindr. Participants were given information on PrEP and participated in a discrete choice experiment requiring them to choose between 2 baskets of PrEP attributes and compare the chosen "PrEP only" option to default options of "condoms only" or "PrEP with condoms." Generalized multinomial logit model was used to examine the scaling effect and preference heterogeneity. Latent class analysis was conducted to examine preference heterogeneity in the sample. RESULTS: Latent class analysis revealed 3 classes of GBMSM: PrEP conservatives (53.9%), moderates (31.1%), and liberals (14.9%). PrEP conservatives were more likely to report greater utility when using condoms only compared with PrEP only, as well as PrEP with condoms, compared with PrEP only, and more likely to report the lowest utility for PrEP as perceived HIV risk increased. PrEP liberals were more likely to report greatest utilities for PrEP only compared with condoms only, as well as PrEP only compared with PrEP with condoms. The utility for PrEP was not affected by perceived risk of HIV or sexually transmitted infections when risks were low. CONCLUSION: This study provides some evidence for risk compensation among a class of GBMSM who already perceived themselves to be good candidates for PrEP before the discrete choice experiment.

Clinical and pharmacoeconomic evaluation of antifungal prophylaxis with continuous micafungin in patients undergoing allogeneic stem cell transplantation: A six-year cohort analysis.

BACKGROUND: Patients undergoing allogeneic stem cell transplantation (aSCT) are at high risk to develop an invasive fungal disease (IFD). Optimisation of antifungal prophylaxis strategies may improve patient outcomes and reduce treatment costs. OBJECTIVES: To analyse the clinical and economical impact of using continuous micafungin as antifungal prophylaxis. PATIENTS/METHODS: We performed a single-centre evaluation comparing patients who received either oral posaconazole with micafungin as intravenous bridging as required (POS-MIC) to patients who received only micafungin (MIC) as antifungal prophylaxis after aSCT. Epidemiological, clinical and direct treatment cost data extracted from the Cologne Cohort of Neutropenic Patients (CoCoNut) were analysed. RESULTS: Three hundred and thirteen patients (97 and 216 patients in the POS-MIC and MIC groups, respectively) were included into the analysis. In the POS-MIC and MIC groups, median overall length of stay was 42 days (IQR: 35-52 days) vs 40 days (IQR: 35-49 days; p = .296), resulting in median overall costs of €42,964 (IQR: €35,040-€56,348) vs €43,291 (IQR: €37,281 vs €51,848; p = .993), respectively. Probable/proven IFD in the POS-MIC and MIC groups occurred in 5 patients (5%) vs 3 patients (1%; p = .051), respectively. The Kaplan-Meier analysis showed improved outcome of patients in the MIC group at day 100 (p = .037) and day 365 (p < .001) following aSCT. CONCLUSIONS: Our study results demonstrate improved outcomes in the MIC group compared with the POS-MIC group, which can in part be explained by a tendency towards less probable/proven IFD. Higher drug acquisition costs of micafungin did not translate into higher overall costs.

National Trends in Drug Payments for HIV Preexposure Prophylaxis in the United States, 2014 to 2018 : A Retrospective Cohort Study.

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.

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.

Ending the HIV Epidemic Among Persons Who Inject Drugs: A Cost-Effectiveness Analysis in Six US Cities.

BACKGROUND: Persons who inject drugs (PWID) are at a disproportionately high risk of HIV infection. We aimed to determine the highest-valued combination implementation strategies to reduce the burden of HIV among PWID in 6 US cities. METHODS: Using a dynamic HIV transmission model calibrated for Atlanta, Baltimore, Los Angeles, Miami, New York City, and Seattle, we assessed the value of implementing combinations of evidence-based interventions at optimistic (drawn from best available evidence) or ideal (90% coverage) scale-up. We estimated reduction in HIV incidence among PWID, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) for each city (10-year implementation; 20-year horizon; 2018 $ US). RESULTS: Combinations that maximized health benefits contained between 6 (Atlanta and Seattle) and 12 (Miami) interventions with ICER values ranging from $94 069/QALY in Los Angeles to $146 256/QALY in Miami. These strategies reduced HIV incidence by 8.1% (credible interval [CI], 2.8%-13.2%) in Seattle and 54.4% (CI, 37.6%-73.9%) in Miami. Incidence reduction reached 16.1%-75.5% at ideal scale. CONCLUSIONS: Evidence-based interventions targeted to PWID can deliver considerable value; however, ending the HIV epidemic among PWID will require innovative implementation strategies and supporting programs to reduce social and structural barriers to care.

Pre-exposure prophylaxis for preventing acquisition of HIV: A cross-sectional study of patients, prescribers, uptake, and spending in the United States, 2015-2016.

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.

Low willingness to pay for pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) in China.

BACKGROUND: Pre-exposure prophylaxis (PrEP) is recommended as an HIV prevention strategy for key populations, in particular men who have sex with men (MSM). However, the willingness to pay market rate for PrEP is largely unknown. This study aimed to investigate the willingness to pay for PrEP and its associated factors among MSM living in Mainland China. METHODS: A cross-sectional survey was conducted among 689 MSM who were recruited through a gay-friendly health consulting service center in Chengdu, China during 2018-2019. We collected information on participants' willingness to pay for PrEP and its potential correlates (e.g., PrEP awareness and acceptability, perceived risk of HIV infection) using a structured questionnaire. Univariate and multivariate logistic regression were used for data analyses. RESULTS: Only 14.1% of respondents indicated they would not pay any money for PrEP, around half (49.3%) would like to pay $14-84 per month, and very few (6.8%) would like to pay ≥283 per month (market rate). We found that PrEP awareness (unadjusted odds ratio (ORu) = 1.41; 95% CI: 1.01-1.97), acceptability (ORu =1.20; 95% CI: 1.07-1.34), perceived PrEP adherence (ORu =1.23; 95% CI: 1.08-1.41), and perceived PrEP benefit in reducing condom use (ORu =1.29; 95% CI: 1.07-1.55) were all associated with participants' willingness to pay the market rate for PrEP. Other facilitators of PrEP pay willingness included full disclosure of sexual orientation to health professionals, high HIV literacy, and a high degree of HIV disclosure with sex partners. CONCLUSIONS: The overall willingness to pay for the market rate of PrEP was low among this urban sample of Chinese MSM. Programs aiming to promote PrEP pay willingness should provide enhanced counseling to improve PrEP-related cognition, deliver accurate HIV/PrEP information to increase health literacy, and decrease stigma towards sexual minorities to develop trust with health professionals.

Cost utility analysis of HIV pre exposure prophylaxis among men who have sex with men in Israel.

BACKGROUND: Between 2011 and 2015, Men who have sex with men (MSM) accounted for nearly half of new HIV cases among men in Israel. This study carries out a cost-utility analysis of PrEP (HIV Pre Exposure Prophylaxis), an antiretroviral medication that can protect against the acquisition of HIV infection, whose incidence rate in Israel is around 1.74 per 1000 MSM. METHOD: Epidemiological, demographic, health service utilisation and economic data were integrated into a spread-sheet model in order to calculate the cost per averted disability-adjusted life year (DALY) of the intervention from a societal perspective, in mid-2018 US$ using a 3% discount rate. Cost utility analyses were performed for both types of PrEP delivery (continuous regimen and on-demand), together with sensitivity analyses on numbers of condom users who take up PrEP (baseline 25%) and subsequently abandon condom use (baseline 75%), PrEP efficacy (baseline 86%), PrEP prices and monitoring costs. RESULTS: Around 21.3% of MSM are high risk (as defined by having unprotected anal intercourse). Offering PrEP to this group would have a ten year net cost of around 1563 million USD, preventing 493 persons from becoming HIV-positive, averting around 1616 DALYs at a cost per averted DALY of around 967,744 USD. This will render the intervention to be not cost-effective. PrEP drug prices would have to fall dramatically (by 90.7%) for the intervention to become cost-effective (i.e. having a cost per averted DALY less than thrice GNP per capita) in Israel. PrEP remains not cost-effective (at 475,673 USD per averted DALY) even if intervention costs were reduced by using an "on demand" instead of a daily schedule. Even if there were no changes in condom use, the resultant 411,694 USD cost-utility ratio is still not cost-effective. CONCLUSIONS: Despite PrEPs high effectiveness against HIV, PrEP was found not to be cost-effective in the Israeli context because of a combination of relatively low HIV incidence, high PrEP costs, with a likelyhood that some low-risk MSM (ie: who use condoms) may well begin taking PrEP and as a consequence many of these will abandon condom use. Therefore, ways of minimizing these last two phenomena need to be found.

Estimated costs for the delivery of safer conception strategies for HIV-discordant couples in Zimbabwe: a cost analysis.

BACKGROUND: In recent years, safer conception strategies have been developed to help HIV-serodiscordant couples conceive a child without transmitting HIV to the seronegative partner. The SAFER clinical trial assessed implementation of these strategies in Zimbabwe. METHODS: As a part of the SAFER study, we estimated the costs (in 2017 $US) associated with individual and combination strategies, in the trial setting and real-world practice, from a healthcare system perspective. Safer conception strategies included: 1) ART with frequent viral load testing until achieving undetectable viral load (ART-VL); 2) daily oral pre-exposure prophylaxis (PrEP); 3) semen-washing with intrauterine insemination; and 4) manual self-insemination at home. For costs in the trial, we used a micro-costing approach, including a time and motion study to quantify personnel effort, and estimated the cost per couple for individual and combination strategies for a mean of 6 months of safer services. For real-world practice, we modeled costs for three implementation scenarios, representing differences from the trial in input prices (paid by the Ministry of Health and Child Care [MOHCC]), intervention intensity, and increments to current HIV prevention and treatment practices and guidelines. We used one-way sensitivity analyses to assess the impact of uncertainty in input variables. RESULTS: Individual strategy costs were $769-$1615 per couple in the trial; $185-$563 if using MOHCC prices. Under the target intervention intensity and using MOHCC prices, individual strategy costs were $73-$360 per couple over and above the cost of current HIV clinical practices. The cost of delivering the most commonly selected combination, ART-VL plus PrEP, ranged from $166-$517 per couple under the three real-world scenarios. Highest costs were for personnel, lab tests, and strategy-specific consumables, in variable proportions by clinical strategy and analysis scenario. Total costs were most affected by uncertainty in the price of PrEP, number of semen-washing attempts, and scale-up of semen-washing capacity. CONCLUSIONS: Safer conception methods have costs that may be affordable in many low-resource settings. These cost data will help implementers and policymakers add safer conception services. Cost-effectiveness analysis is needed to assess value for money for safer conception services overall and for safer strategy combinations. TRIAL REGISTRATION: Registry Name: Clinicaltrials.gov. TRIAL REGISTRATION NUMBER: NCT03049176 . Registration date: February 9, 2017.

Rabies vaccination strategies in the Netherlands in 2018: a cost evaluation.

BackgroundThe risk of contracting rabies is low for travellers. However, the number of Dutch travellers potentially exposed abroad following an animal-associated injury and needing post-exposure prophylaxis (PEP) has increased, resulting in increased costs.AimHere, we evaluated the costs and the cost-effectiveness of different pre- and post-exposure interventions in the Netherlands, taking into account the 2018 World Health Organization (WHO) recommendations for the prevention of rabies.MethodsA decision tree-based economic model was constructed. We calculated and compared the cost of different WHO pre-exposure prophylaxis (PrEP) recommendations, intramuscular vs intradermal vaccination and PEP subsequent to increased vaccination coverage in risk groups. We estimated cost-effectiveness, expressed as incremental costs per rabies immunoglobulin (RIG) administration averted, using a societal perspective. Statistical uncertainty regarding number of travellers and vaccination coverage was assessed.ResultsTotal costs at the national level were highest using previous WHO recommendations from 2012, estimated at EUR 15.4 million annually. Intradermal vaccinations in combination with the current recommendations led to the lowest costs, estimated at EUR 10.3 million. Higher vaccination uptake resulted in higher overall costs. The incremental costs per RIG administration averted varied from EUR 21,300-46,800.ConclusionsThe change in rabies PrEP and PEP recommendations in 2018 reduced total costs. Strategies with increased pre-travel vaccination uptake led to fewer RIG administrations and fewer vaccinations after exposure but also to higher total costs. Although larger scale intradermal administration of rabies vaccine can reduce total costs of PrEP and can positively influence vaccination uptake, it remains a costly intervention.

[Cost-effectiveness analysis for HIV pre-exposure prophylaxis in a high-risk population in the Czech Republic].

OBJECTIVES: To assess the cost-effectiveness of pharmacological pre-exposure prophylaxis (PrEP) using a combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) with respect to HIV transmission in high-risk patients in the Czech Republic. MATERIAL AND METHODS: A pharmacoeconomic model was constructed to compare costs and outcomes in a cohort with and without PrEP. Initially, a decision tree is used to evaluate short-term benefits of PrEP (proportion of HIV-infected individuals), followed by Markov cycles to simulate the course of the disease based on CD4 lymphocyte counts. The efficacy of PrEP, probability of transition between HIV infection stages, costs per category and quality of life data were derived from the literature. The results are presented as an incremental cost effectiveness ratio of incremental costs and incremental quality adjusted life-years (ICER/QALY) in a lifetime horizon with a 3% annual discount rate of costs and benefits. RESULTS: The FTC/TDF prophylaxis is dominant, that is, it generates lower costs and higher benefits (expressed as QALYs) in comparison with the control group without prophylaxis. A sensitivity analysis modelled all relevant parameters and all scenarios confirmed the PrEP dominance. CONCLUSIONS: A cost-effectiveness analysis in the Czech Republic setting confirmed that pharmacological PrPE intervention is cost-effective, or cost-saving, in a high-risk population of men having sex with men, using a lifetime horizon.

Update on HIV prevention and preexposure prophylaxis.

HIV preexposure prophylaxis (PrEP) is an opportunity for clinicians to curb the 40,000 HIV infections occurring annually in the United States. PrEP is medication used by HIV-negative patients to reduce their risk of acquiring the virus. This article provides a baseline understanding of PrEP indications, prescribing, and monitoring, including a review of previously approved medication and an update on newly approved drugs, including emtricitabine/tenofovir alafenamide (F/TAF). Sexual and gender minorities are often underrepresented in the literature about PrEP, but clinicians should address risk focused on specific behaviors rather than population-level characteristics. As one of few professions with prescriptive authority, PAs have an obligation to understand and manage PrEP.

A Review of Telehealth Innovations for HIV Pre-Exposure Prophylaxis (PrEP).

PURPOSE OF REVIEW: This review summarizes novel interventions that employ technology to improve HIV pre-exposure prophylaxis (PrEP) availability, uptake, and adherence. RECENT FINDINGS: Several notable technology-based programs are increasing access to PrEP in unique ways. We identified multiple models for using telehealth to bolster PrEP dissemination and adherence, such as mobile applications that offer PrEP prescribing without an in-person visit, longitudinal distance telementoring for community provider PrEP education and clinical guidance, and electronic consults for PrEP specialist support in the primary care setting. Outcomes data for all of these modalities are limited but show promise. Technology-based interventions can address gaps in the PrEP care continuum. Future research should assess and compare outcomes, scalability, cost-effectiveness, and sustainability. Costs associated with the creation of new technological tools slow innovation and the field would benefit from a platform for technology sharing.