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Background In a recent randomized controlled trial, daily oral preexposure chemoprophylaxis (PrEP) was shown to be effective for HIV prevention in men who have sex with men (MSM). The United States Centers for Disease Control and Prevention (CDC) recently provided interim guidance for PrEP use among MSM who are at high risk for acquiring HIV. Previous studies failed to reach a consistent estimate of its cost-effectiveness. Objective To estimate the effectiveness and cost-effectiveness of PrEP in MSM in the United States. Design Dynamic model of HIV transmission and progression combined with a detailed economic analysis. Data Sources Published literature. Target Population MSM aged 13–64 in the United States. Time Horizon Lifetime. Perspective Societal. Interventions We evaluated PrEP for the general MSM population and for high-risk MSM. We assumed that PrEP reduces infection risk by 44%, based on clinical trial results. Outcome Measures New HIV infections, discounted quality-adjusted life-years (QALYs) and costs, and incremental cost-effectiveness ratios. Results of Base-Case Analysis If PrEP is initiated in 20% of MSM in the United States, we estimate a 13% reduction in new HIV infections and a gain of 550,166 QALYs over 20 years at a cost of $172,091/QALY gained. Initiating PrEP in a larger proportion of MSM averts more infections but at increasing cost per QALY gained ($216,480/QALY gained when 100% of MSM receive PrEP). Using PrEP only in high-risk MSM can improve its cost-effectiveness. PrEP costs approximately $50,000/QALY gained for MSM with 5 annual partners on average. PrEP for all high-risk MSM for 20 years leads to $75 billion in healthcare-related costs incremental to the status quo and costs $600,000 per HIV infection averted, compared with incremental costs of $95 billion and $2 million per infection averted for 20% coverage of all MSM. Results of Sensitivity Analysis PrEP use in the general MSM population costs less than $100,000/QALY gained if the daily cost of antiretroviral drugs for PrEP is less than $15 or if PrEP efficacy is greater than 75%. Limitation When examining PrEP use in high-risk MSM, we did not model mixing between low- and high-risk MSM because of lack of data on mixing patterns. Conclusion Use of PrEP for HIV prevention in the general MSM population could prevent a substantial number of HIV infections but is expensive. PrEP use in high-risk MSM compares favorably to other interventions considered cost-effective, but could result in annual expenditures on PrEP of over $4 billion.

Background-Although recent guidelines call for expanded routine screening for HIV, resources for antiretroviral treatment (ART) are limited and all eligible people are not currently being treated.

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