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Prioritizing HIV comparative effectiveness trials based on value of information
Generic versus brand-name ART in the US
Pei, P. P., Weinstein, M. C., Li, X., Hughes, M. D., Paltiel, A. D., Hou, T., Parker, R. A., Gaynes, M. R., Walensky, R. P., Sax, P. E., Schackman, B. R., & Freedberg, K. A. (2015). Prioritizing HIV comparative effectiveness trials based on value of information: Generic versus brand-name ART in the US. HIV Clinical Trials, 16(6), 207-218. https://doi.org/10.1080/15284336.2015.1123942
Background: Value of Information (VOI) analysis examines whether to acquire information before making a decision. We introduced VOI to the HIV audience, using the example of generic antiretroviral therapy (ART) in the US.
Methods and findings: We used a mathematical model and probabilistic sensitivity analysis (PSA) to generate probability distributions of survival (in quality-adjusted life years, QALYs) and cost for three potential first-line ART regimens: three-pill generic, two-pill generic, and single-pill branded. These served as input for a comparison of two hypothetical two-arm trials: three-pill generic versus single-pill branded; and two-pill generic versus single-pill branded. We modeled pre-trial uncertainty by defining probability distributions around key inputs, including 24-week HIV-RNA suppression and subsequent ART failure. We assumed that, without a trial, patients received the single-pill branded strategy. Post-trial, we assumed that patients received the most cost-effective strategy. For both trials, we quantified the probability of changing to a generic-based regimen upon trial completion and the expected VOI in terms of improved health outcomes and costs. Assuming a willingness to pay (WTP) threshold of $100 000/QALY, the three-pill trial led to more treatment changes (84%) than the two-pill trial (78%). Estimated VOI was $48 000 (three-pill trial) and $35 700 (two-pill trial) per future patient initiating ART.
Conclusions: A three-pill trial of generic ART is more likely to lead to post-trial treatment changes and to provide more value than a two-pill trial if policy decisions are based on cost-effectiveness. Value of Information analysis can identify trials likely to confer the greatest impact and value for HIV care.
Keywords: Cost-effectiveness analysis; Decision modeling; Generic drugs; HIV; Value of information.