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Prioritizing HIV comparative effectiveness trials based on value of information: generic versus brand-name ART in the US.


ABSTRACT: 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.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.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.

SUBMITTER: Pei PP 

PROVIDER: S-EPMC4718767 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Prioritizing HIV comparative effectiveness trials based on value of information: generic versus brand-name ART in the US.

Pei Pamela P PP   Weinstein Milton C MC   Li X Cynthia XC   Hughes Michael D MD   Paltiel A David AD   Hou Taige T   Parker Robert A RA   Gaynes Melanie R MR   Sax Paul E PE   Freedberg Kenneth A KA   Schackman Bruce R BR   Walensky Rochelle P RP  

HIV clinical trials 20151101 6


<h4>Background</h4>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.<h4>Methods and findings</h4>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-p  ...[more]

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