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. 2017 May 24;5(2):13.
doi: 10.3390/vaccines5020013.

The Potential Cost-Effectiveness of Pre-Exposure Prophylaxis Combined with HIV Vaccines in the United States

Blythe J S Adamson  1 , Josh J Carlson  2 , James G Kublin  3   4 , Louis P Garrison  5   6
Affiliations

The Potential Cost-Effectiveness of Pre-Exposure Prophylaxis Combined with HIV Vaccines in the United States

Blythe J S Adamson et al. Vaccines (Basel). .

Abstract

This economic evaluation aims to support policy-making on the combined use of pre-exposure prophylaxis (PrEP) with HIV vaccines in development by evaluating the potential cost-effectiveness of implementation that would support the design of clinical trials for the assessment of combined product safety and efficacy. The target study population is a cohort of men who have sex with men (MSM) in the United States. Policy strategies considered include standard HIV prevention, daily oral PrEP, HIV vaccine, and their combination. We constructed a Markov model based on clinical trial data and the published literature. We used a payer perspective, monthly cycle length, a lifetime horizon, and a 3% discount rate. We assumed a price of $500 per HIV vaccine series in the base case. HIV vaccines dominated standard care and PrEP. At current prices, PrEP was not cost-effective alone or in combination. A combination strategy had the greatest health benefit but was not cost-effective (ICER = $463,448/QALY) as compared to vaccination alone. Sensitivity analyses suggest a combination may be valuable for higher-risk men with good adherence. Vaccine durability and PrEP drug prices were key drivers of cost-effectiveness. The results suggest that boosting potential may be key to HIV vaccine value.

Keywords: HIV vaccines; cost-effectiveness; economic evaluation; mathematical modeling; pre-exposure prophylaxis.

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Conflict of interest statement

The authors declare no conflict of interest. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality or the National Institutes of Health. The founding sponsors had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, and in the decision to publish the results.

Figures

Figure A1
Figure A1
Incident HIV infections among men-who-have-sex-with-men (MSM) in the United States, based on 2012 CDC surveillance data [32].
Figure A2
Figure A2
Percent reduction in HIV infection for HIV vaccines and PrEP as modeled in the analysis. Intervention efficacy assumptions for (a) HIV vaccine efficacy decaying over time with boosting every 5 years and (b) PrEP by the level of adherence. Abbreviations: PrEP, Pre-exposure prophylaxis; VE, vaccine efficacy.
Figure 1
Figure 1
Simplified conceptual diagram of health states in the Markov model.
Figure 2
Figure 2
Efficacy and epidemic impact of HIV prevention strategies. The top panel shows the average efficacy over time given each strategy and the lower panel shows the number of new infections per month per 100,000 persons in the cohort of men. Baseline HIV incidence declines with age categories.
Figure 3
Figure 3
Cost-effectiveness results for potential prevention policies. The cost-effectiveness plane in panel (a) shows the origin representing standard preventative care, y-axes as the average incremental lifetime discounted costs per-person, and x-axis of QALYs gained for each policy strategy as compared to standard prevention. A solid line represents the cost-effectiveness frontier for the base-case population of all MSM and a dashed line connects a high-risk scenario. Panel (b) shows results from the probabilistic sensitivity analysis as a cost-effectiveness acceptability curve. Abbreviations: QALYs, quality-adjusted life-years; ICER, incremental cost-effectiveness ratio; MSM, men who have sex with men; PrEP, pre-exposure prophylaxis.
Figure 4
Figure 4
Tornado diagram of the one-way sensitivity analysis showing the impact of minimum and maximum parameter ranges on the ICER of the combination strategy versus HIV vaccines alone. Univariate sensitivity of the PrEP duration shows that 1 year or 10 years on PrEP in the combination strategy have larger ICERs than the base case assumption of 5 years duration, because the balance of lifetime PrEP costs and benefits is closer to the optimization of duration at 5 compared to 1 or 10 years.
Figure 5
Figure 5
Sensitivity analyses of the cost-effectiveness of pairwise comparisons of scenarios versus standard care suggest that strategies would be more cost-effective with younger populations, higher-risk men, shorter duration on PrEP, and added HIV vaccine boosting. The darker blue color represents greater cost-effectiveness and the lighter color represents scenarios dominated or unlikely to be cost-effective as compared to the standard care.
Figure 5
Figure 5
Sensitivity analyses of the cost-effectiveness of pairwise comparisons of scenarios versus standard care suggest that strategies would be more cost-effective with younger populations, higher-risk men, shorter duration on PrEP, and added HIV vaccine boosting. The darker blue color represents greater cost-effectiveness and the lighter color represents scenarios dominated or unlikely to be cost-effective as compared to the standard care.
Figure 6
Figure 6
Distribution of incremental costs and QALYs per person among 1000 Monte Carlo simulations in the probabilistic sensitivity analysis. The ellipse represents 95% credible ranges around the average estimate for each strategy.
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