A recent randomized, controlled trial showed that daily oral preexposure chemoprophylaxis (PrEP) was effective for HIV prevention in men who have sex with men (MSM). The Centers for Disease Control and Prevention recently provided interim guidance for PrEP in MSM at high risk for HIV. Previous studies did not reach a consistent estimate of its cost-effectiveness.
To estimate the effectiveness and cost-effectiveness of PrEP in MSM in the United States.
Dynamic model of HIV transmission and progression combined with a detailed economic analysis.
MSM aged 13 to 64 years in the United States.
PrEP was evaluated in both the general MSM population and in high-risk MSM and was assumed to reduce infection risk by 44% on the basis of clinical trial results.
New HIV infections, discounted quality-adjusted life-years (QALYs) and costs, and incremental cost-effectiveness ratios.
Initiating PrEP in 20% of MSM in the United States would reduce new HIV infections by an estimated 13% and result in a gain of 550,166 QALYs over 20 years at a cost of $172,091 per QALY gained. Initiating PrEP in a larger proportion of MSM would prevent more infections but at an increasing cost per QALY gained (up to $216,480 if all MSM receive PrEP). Preexposure chemoprophylaxis in only high-risk MSM can improve cost-effectiveness. For MSM with an average of 5 partners per year, PrEP costs approximately $50,000 per QALY gained. Providing PrEP to all high-risk MSM for 20 years would cost $75 billion more in health care-related costs than the status quo and $600,000 per HIV infection prevented, compared with incremental costs of $95 billion and $2 million per infection prevented for 20% coverage of all MSM.
PrEP in the general MSM population would cost less than $100,000 per QALY gained if the daily cost of antiretroviral drugs for PrEP was less than $15 or if PrEP efficacy was greater than 75%.
When examining PrEP in high-risk MSM, the investigators did not model a mix of low- and high-risk MSM because of lack of data on mixing patterns.
PrEP in the general MSM population could prevent a substantial number of HIV infections, but it is expensive. Use in high-risk MSM compares favorably with other interventions that are considered cost-effective but could result in annual PrEP expenditures of more than $4 billion.
National Institute on Drug Abuse, Department of Veterans Affairs, and National Institute of Allergy and Infectious Diseases.
"Benefits and costs of PrEP were then assessed over 20 years of PrEP use by MSM. If 20% of all MSM were to use PrEP, more than 62,000 new cases of HIV infection would be prevented, with a resulting declining prevalence of HIV by 10% at 20 years compared with no PrEP . However, the incremental cost for the healthcare budget would be significant (USD 95 billion), with a cost of more than USD 172,000 per quality-adjusted life-year (QALY) much higher than would be considered to be a cost-effective strategy. "
[Show abstract][Hide abstract] ABSTRACT: Following US Food and Drugs Administration approval in July 2012 of daily oral tenofovir and emtricitabine for pre-exposure prophylaxis (PrEP) to prevent HIV infection in high-risk individuals in the USA, there has been much controversy about the implementation of this PrEP regimen in other countries throughout the world, and in Europe in particular. In this review, we focus on the challenges and opportunities of a daily oral PrEP regimen to curb the rising incidence of HIV infection in high-risk groups, and particularly in men who have sex with men. A number of issues would need to be addressed before PrEP could be implemented, including assessing the real effectiveness and cost-effectiveness of daily PrEP, the sustainability of daily adherence, the risk of selecting resistance, the long-term safety, and the risk of change in sexual behavior that might offset the benefit of PrEP. Alternatives to a daily oral PrEP regimen are being explored.
BMC Medicine 08/2013; 11(1):186. DOI:10.1186/1741-7015-11-186 · 7.25 Impact Factor
"While this has hopeful implications for those community members with access to healthcare, as noted by participants, this could create a situation of the ‘haves and have-nots,’ with an unequal distribution of medication and services. In an ever-increasing, resource-limited HIV prevention field, officials must decide if combination prevention approaches are the best use of funds when other, more cost-effective, strategies already exist
[56-58]. This is a particularly important consideration as providers attempt to balance biomedical-focused interventions, like treatment as prevention and testing and linkage to care, with prevention programs that focus on the social dimensions of HIV prevention efforts
[Show abstract][Hide abstract] ABSTRACT: Background
An international randomized clinical trial (RCT) on pre-exposure prophylaxis (PrEP) as an human immunodeficiency virus (HIV)-prevention intervention found that taken on a daily basis, PrEP was safe and effective among men who have sex with men (MSM) and male-to-female transgender women. Within the context of the HIV epidemic in the United States (US), MSM and transgender women are the most appropriate groups to target for PrEP implementation at the population level; however, their perspectives on evidenced-based biomedical research and the results of this large trial remain virtually unknown. In this study, we examined the acceptability of individual daily use of PrEP and assessed potential barriers to community uptake.
We conducted semi-structured interviews with an ethnoracially diverse sample of thirty HIV-negative and unknown status MSM (n = 24) and transgender women (n = 6) in three California metropolitan areas. Given the burden of disease among ethnoracial minorities in the US, we purposefully oversampled for these groups. Thematic coding and analysis of data was conducted utilizing an approach rooted in grounded theory.
While participants expressed general interest in PrEP availability, results demonstrate: a lack of community awareness and confusion about PrEP; reservations about PrEP utilization, even when informed of efficacious RCT results; and concerns regarding equity and the manner in which a PrEP intervention could be packaged and marketed in their communities.
In order to effectively reduce HIV health disparities at the population level, PrEP implementation must take into account the uptake concerns of those groups who would actually access and use this biomedical intervention as a prevention strategy. Recommendations addressing these concerns are provided.
[Show abstract][Hide abstract] ABSTRACT: Background HIV Pre-exposure prophylaxis (PrEP), the use of antiretroviral drugs by those HIV uninfected individuals to prevent HIV infection, recently demonstrated effectiveness in preventing acquisition in a high risk population of men who have sex with men (MSM). There is a need to understand if and how PrEP can be used cost-effectively. This study examines the programmatic implications of the iPrEX study: the only randomised controlled trial of PrEP among men who have sex with men (MSM) published last December in the New England Journal of Medicine.
Methods We developed a mathematical model representing the HIV epidemic among Men who Have Sex with Men (MSM) and transgender people in Lima, Peru as a test-case. It considers differential infectiousness by stage, including the impact of antiretroviral treatment and different sexual practices, such as partnerships type and sexual positioning. The model was used to investigate the population-level impact, cost, and cost-effectiveness of PrEP under a range of implementation scenarios, and to develop possible strategies by which PrEP could be implemented.
Results The epidemiological impact of PrEP is largely driven by programme characteristics—coverage, prioritisation strategy and time to scale up—as well as individual's adherence behaviour. If PrEP is prioritised to key groups, it could be a cost-effective way to avert infection and save lives (up to 8% less new infections with 5% coverage). Across all our scenarios the estimated highest cost per DALY gained (US$$2755) is below the WHO recommended threshold for cost-effective interventions for the region (<US$$4608/DALY gained) see Abstract LBO-1.2 Figure 1. The impact of PrEP is reduced if those on PrEP decrease condom use, especially if the program has low coverage; but only extreme behaviour changes and a low PrEP efficacy would adversely impact the epidemic overall. However, PrEP will not arrest HIV transmission in isolation, due to its incomplete effectiveness, dependence on adherence, and the high total cost of programmes limiting attainable coverage levels.
Conclusions This study quantifies the epidemic and financial implications of different programmatic scenarios. While the implementation of a strategic PrEP intervention has potentially important financial implications (a substantial expenditure would likely be required to generate significant reductions in incidence), PrEP among vulnerable populations could be a cost-effective option comparable to currently available interventions for Men who Have Sex with Men (MSM) populations.
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