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Background: Updated World Health Organization guidelines have amplified debate about how resource constraints should impact monitoring strategies for HIV‐infected persons on combination antiretroviral therapy (cART). We estimated the incremental benefit and cost effectiveness of alternative monitoring strategies for east Africans with known HIV infection. Methods: Using a validated HIV computer simulation based on resource‐limited data (USAID and AMPATH) and circumstances (east Africa), we compared alternative monitoring strategies for HIV‐infected persons newly started on cART. We evaluated clinical, immunologic and virologic monitoring strategies, including combinations and conditional logic (e.g., only perform virologic testing if immunologic testing is positive). We calculated incremental cost‐effectiveness ratios (ICER) in units of cost per quality‐adjusted life year (QALY), using a societal perspective and a lifetime horizon. Costs were measured in 2008 US dollars, and costs and benefits were discounted at 3%. We compared the ICER of monitoring strategies with those of other resource‐constrained decisions, in particular earlier cART initiation (at CD4 counts of 350 cells/mm[sup.3] rather than 200 cells/mm[sup.3]). Results: Monitoring strategies employing routine CD4 testing without virologic testing never maximized health benefits, regardless of budget or societal willingness to pay for additional health benefits. Monitoring strategies employing virologic testing conditional upon particular CD4 results delivered the most benefit at willingness‐to‐pay levels similar to the cost of earlier cART initiation (approximately $2600/QALY). Monitoring strategies employing routine virologic testing alone only maximized health benefits at willingness‐to‐pay levels (> $4400/QALY) that greatly exceeded the ICER of earlier cART initiation. Conclusions: CD4 testing alone never maximized health benefits regardless of resource limitations. Programmes routinely performing virologic testing but deferring cART initiation may increase health benefits by reallocating monitoring resources towards earlier cART initiation., Background Considerable debate exists about how resource constraints should impact laboratory monitoring for HIV‐infected patients on combination antiretroviral therapy (cART) [1‐6]. This lack of consensus is reflected in the equivocal [...]

Background There are too many plausible permutations and scale-up scenarios of combination hepatitis C virus (HCV) interventions for exhaustive testing in experimental trials. Therefore, we used a computer simulation to project the health and economic impacts of alternative combination intervention scenarios for people who inject drugs (PWID), focusing on direct antiviral agents (DAA) and medication-assisted treatment combined with syringe access programs (MAT+). Methods We performed an allocative efficiency study, using a mathematical model to simulate the progression of HCV in PWID and its related consequences. We combined 2 previously validated simulations to estimate the cost-effectiveness of intervention strategies that included a range of coverage levels. Analyses were performed from a health-sector and societal perspective, with a 15-year time horizon and a discount rate of 3%. Results From a health-sector perspective (excluding criminal justice system–related costs), 4 potential strategies fell on the cost-efficiency frontier. At 20% coverage, DAAs had an incremental cost-effectiveness ratio (ICER) of $27 251/quality-adjusted life-year (QALY). Combinations of DAA at 20% with MAT+ at 20%, 40%, and 80% coverage had ICERs of $165 985/QALY, $325 860/QALY, and $399 189/QALY, respectively. When analyzed from a societal perspective (including criminal justice system–related costs), DAA at 20% with MAT+ at 80% was the most effective intervention and was cost saving. While DAA at 20% with MAT+ at 80% was more expensive (eg, less cost saving) than MAT+ at 80% alone without DAA, it offered a favorable value compared to MAT+ at 80% alone ($23 932/QALY). Conclusions When considering health-sector costs alone, DAA alone was the most cost-effective intervention. However, with criminal justice system–related costs, DAA and MAT+ implemented together became the most cost-effective intervention. [ABSTRACT FROM AUTHOR]

Introduction Health plans, employers, and policymakers are looking for more effective approaches to control health expenditures. Reductions in health expenditures can arise from lowering either the costs or the quantities [...], Background: Evidence suggests that cost sharing (i.e., copayments and deductibles) decreases health expenditures but also reduces essential care. Value-based insurance design (VBID) has been proposed to encourage essential care while controlling health expenditures. Our objective was to estimate the impact of broader diffusion of VBID on US health care benefits and costs. Methods and Findings: We used a published computer simulation of costs and life expectancy gains from US health care to estimate the impact of broader diffusion of VBID. Two scenarios were analyzed: (1) applying VBID solely to pharmacy benefits and (2) applying VBID to both pharmacy benefits and other health care services (e.g., devices). We assumed that cost sharing would be eliminated for high-value services ( Conclusion: Broader diffusion of VBID may amplify benefits from US health care without increasing health expenditures. Please see later in the article for the Editors' Summary.

In integrated health care systems, techniques that identify successes and opportunities for targeted improvement are needed. The authors propose a new method for estimating population health that provides a more accurate and dynamic assessment of performance and priority setting. Member data from a large integrated health system (n = 96,246, 73.8% female, mean age = 44 ± 0.01 years) were used to develop a mechanistic mathematical simulation, representing the top causes of US mortality in 2014 and their associated risk factors. An age- and sex-matched US cohort served as comparator group. The simulation was recalibrated and retested for validity employing the outcome measure of 5-year mortality. The authors sought to estimate potential population health that could be gained by improving health risk factors in the study population. Potential gains were assessed using both average life years (LY) gained and average quality-adjusted life years (QALYs) gained. The simulation validated well compared to integrated health system data, producing an AUC (area under the curve) of 0.88 for 5-year mortality. Current population health was estimated as a life expectancy of 84.7 years or 69.2 QALYs. Comparing potential health gain in the US cohort to the Kaiser Permanente cohort, eliminating physical inactivity, unhealthy diet, smoking, and uncontrolled diabetes resulted in an increase of 1.5 vs. 1.3 LY, 1.1 vs. 0.8 LY, 0.5 vs. 0.2 LY, and 0.5 vs. 0.5 LY on average per person, respectively. Using mathematical simulations may inform efforts by integrated health systems to target resources most effectively, and may facilitate goal setting. [ABSTRACT FROM AUTHOR]

Background: A study of a comprehensive HIV Care Coordination Program (CCP) showed effectiveness in increasing viral load suppression (VLS) among PLWH in New York City (NYC). We evaluated the cost-effectiveness of a scale-up of the CCP in NYC. Methods: We incorporated observed effects and costs of the CCP into a computer simulation of HIV in NYC, comparing strategy scale-up with no implementation. The simulation combined a deterministic compartmental model of HIV transmission with a stochastic microsimulation of HIV progression, and was calibrated to NYC HIV epidemiological data from 1997 to 2009. We assessed incremental cost-effectiveness from a health sector perspective using 2017 $US, a 20-year time horizon, and a 3% annual discount rate. We explored two scenarios: (1) two-year average enrollment and (2) continuous enrollment. Results: In scenario 1, scale-up resulted in a cost-per-infection-averted of $898,104 and a cost-per-QALY-gained of $423,721. In sensitivity analyses, scale-up achieved cost-effectiveness if effectiveness increased from RR1.11 to RR1.37 or costs decreased by 41.7%. Limiting the intervention to persons with unsuppressed viral load prior to enrollment (RR1.32) attenuated the cost reduction necessary to 11.5%. In scenario 2, scale-up resulted in a cost-per-infection-averted of $705,171 and cost-per-QALY-gained of $720,970. In sensitivity analyses, scale-up achieved cost-effectiveness if effectiveness increased from RR1.11 to RR1.46 or program costs decreased by 71.3%. Limiting the intervention to persons with unsuppressed viral load attenuated the cost reduction necessary to 38.7%. Conclusion: Cost-effective CCP scale-up would require reduced costs and/or focused enrollment within NYC, but may be more readily achieved in cities with lower background VLS levels. [ABSTRACT FROM AUTHOR]

Introduction: Link4Health, a cluster-RCT, demonstrated the effectiveness of a combination strategy targeting barriers at various HIV continuum steps on linkage to and retention in care; showing effectiveness in achieving linkage to HIV care within 1 month plus retention in care at 12 months after HIV testing for people living with HIV (RR 1.48, 95% CI 1.19–1.96, p = 0.002). In addition to standard of care, Link4Health included: 1) Point-of-care CD4+ count testing; 2) Accelerated ART initiation; 3) Mobile phone appointment reminders; 4) Care and prevention package including commodities and informational materials; and 5) Non-cash financial incentive. Our objective was to evaluate the cost-effectiveness of a scale-up of the Link4Health strategy in Swaziland. Methods and findings: We incorporated the effects and costs of the Link4Health strategy into a computer simulation of the HIV epidemic in Swaziland, comparing a scenario where the strategy was scaled up to a scenario with no implementation. The simulation combined a deterministic compartmental model of HIV transmission with a stochastic microsimulation of HIV progression calibrated to Swaziland epidemiological data. It incorporated downstream health costs potentially saved and infections potentially prevented by improved linkage and treatment adherence. We assessed the incremental cost-effectiveness ratio of Link4Health compared to standard care from a health sector perspective reported in US$2015, a time horizon of 20 years, and a discount rate of 3% in accordance with WHO guidelines.[] Our results suggest that scale-up of the Link4Health strategy would reduce new HIV infections over 20 years by 11,059 infections, a 7% reduction from the projected 169,019 cases and prevent 5,313 deaths, an 11% reduction from the projected 49,582 deaths. Link4Health resulted in an incremental cost per infection prevented of $13,310 and an incremental cost per QALY gained of $3,560/QALY from the health sector perspective. Conclusions: Using a threshold of <3 x per capita GDP, the Link4Health strategy is likely to be a cost-effective strategy for responding to the HIV epidemic in Swaziland. [ABSTRACT FROM AUTHOR]

Objective: To inform the design of a combination intervention strategy targeting HIV-infected unhealthy alcohol users in Maharashtra, India, that could be tested in future randomized control trials. Methods: Using probabilistic compartmental simulation modeling we compared intervention strategies targeting HIV-infected unhealthy alcohol users on antiretroviral therapy (ART) in Maharashtra, India. We tested interventions targeting four behaviors (unhealthy alcohol consumption, risky sexual behavior, depression and antiretroviral adherence), in three formats (individual, group based, community) and two durations (shorter versus longer). A total of 5,386 possible intervention combinations were tested across the population for a 20-year time horizon and intervention bundles were narrowed down based on incremental cost-effectiveness analysis using a two-step probabilistic uncertainty analysis approach. Results: Taking into account uncertainty in transmission variables and intervention cost and effectiveness values, we were able to reduce the number of possible intervention combinations to be used in a randomized control trial from over 5,000 to less than 5. The most robust intervention bundle identified was a combination of three interventions: long individual alcohol counseling; weekly Short Message Service (SMS) adherence counseling; and brief sex risk group counseling. Conclusions: In addition to guiding policy design, simulation modeling of HIV transmission can be used as a preparatory step to trial design, offering a method for intervention pre-selection at a reduced cost. [ABSTRACT FROM AUTHOR]

Background In the current report, we ask if targeting a cognitive behavioral therapy ( CBT)-based intervention aimed at reducing hazardous alcohol consumption to HIV-infected persons in East Africa would have a favorable value at costs that are feasible for scale-up. Methods Using a computer simulation to inform HIV prevention decisions in East Africa, we compared 4 different strategies for targeting a CBT intervention-(i) all HIV-infected persons attending clinic; (ii) only those patients in the pre-antiretroviral therapy ( ART) stages of care; (iii) only those patients receiving ART; and (iv) only those patients with detectable viral loads (VLs) regardless of disease stage. We define targeting as screening for hazardous alcohol consumption (e.g., using the Alcohol Use Disorders Identification Test and offering the CBT intervention to those who screen positive). We compared these targeting strategies to a null strategy (no intervention) or a hypothetical scenario where an alcohol intervention was delivered to all adults regardless of HIV status. Results An intervention targeted to HIV-infected patients could prevent 18,000 new infections, add 46,000 quality-adjusted life years ( QALYs), and yield an incremental cost-effectiveness ratio of $600/ QALY compared to the null scenario. Narrowing the prioritized population to only HIV-infected patients in pre- ART phases of care results in 15,000 infections averted, the addition of 21,000 QALYs and would be cost-saving, while prioritizing based on an unsuppressed HIV-1 VL test results in 8,300 new infections averted, adds 6,000 additional QALYs, and would be cost-saving as well. Conclusions Our results suggest that targeting a cognitive-based treatment aimed at reducing hazardous alcohol consumption to subgroups of HIV-infected patients provides favorable value in comparison with other beneficial strategies for HIV prevention and control in this region. It may even be cost-saving under certain circumstances. [ABSTRACT FROM AUTHOR]

Background: Many analyses of HIV treatment decisions assume a fixed formulary of HIV drugs. However, new drugs are approved nearly twice a year, and the rate of availability of new drugs may affect treatment decisions, particularly when to initiate antiretroviral therapy (ART). Objectives: To determine the impact of considering the availability of new drugs on the optimal initiation criteria for ART and outcomes in patients with HIV/AIDS. Methods: We enhanced a previously described simulation model of the optimal time to initiate ART to incorporate the rate of availability of new antiviral drugs. We assumed that the future rate of availability of new drugs would be similar to the past rate of availability of new drugs, and we estimated the past rate by fitting a statistical model to actual HIV drug approval data from 1982–2010. We then tested whether or not the future availability of new drugs affected the model-predicted optimal time to initiate ART based on clinical outcomes, considering treatment initiation thresholds of 200, 350, and 500 cells/mm3. We also quantified the impact of the future availability of new drugs on life expectancy (LE) and quality-adjusted life expectancy (QALE). Results: In base case analysis, considering the availability of new drugs raised the optimal starting CD4 threshold for most patients to 500 cells/mm3. The predicted gains in outcomes due to availability of pipeline drugs were generally small (less than 1%), but for young patients with a high viral load could add as much as a 4.9% (1.73 years) increase in LE and a 8% (2.43 QALY) increase in QALE, because these patients were particularly likely to exhaust currently available ART regimens before they died. In sensitivity analysis, increasing the rate of availability of new drugs did not substantially alter the results. Lowering the toxicity of future ART drugs had greater potential to increase benefit for many patient groups, increasing QALE by as much as 10%. Conclusions: The future availability of new ART drugs without lower toxicity raises optimal treatment initiation for most patients, and improves clinical outcomes, especially for younger patients with higher viral loads. Reductions in toxicity of future ART drugs could impact optimal treatment initiation and improve clinical outcomes for all HIV patients. [ABSTRACT FROM AUTHOR]

Background: New York City (NYC) remains an epicenter of the HIV epidemic in the United States. Given the variety of evidence-based HIV prevention strategies available and the significant resources required to implement each of them, comparative studies are needed to identify how to maximize the number of HIV cases prevented most economically. Methods: A new model of HIV disease transmission was developed integrating information from a previously validated micro-simulation HIV disease progression model. Specification and parameterization of the model and its inputs, including the intervention portfolio, intervention effects and costs were conducted through a collaborative process between the academic modeling team and the NYC Department of Health and Mental Hygiene. The model projects the impact of different prevention strategies, or portfolios of prevention strategies, on the HIV epidemic in NYC. Results: Ten unique interventions were able to provide a prevention benefit at an annual program cost of less than $360,000, the threshold for consideration as a cost-saving intervention (because of offsets by future HIV treatment costs averted). An optimized portfolio of these specific interventions could result in up to a 34% reduction in new HIV infections over the next 20 years. The cost-per-infection averted of the portfolio was estimated to be $106,378; the total cost was in excess of $2 billion (over the 20 year period, or approximately $100 million per year, on average). The cost-savings of prevented infections was estimated at more than $5 billion (or approximately $250 million per year, on average). Conclusions: Optimal implementation of a portfolio of evidence-based interventions can have a substantial, favorable impact on the ongoing HIV epidemic in NYC and provide future cost-saving despite significant initial costs. [ABSTRACT FROM AUTHOR]