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

HIV Clin Trials. 2015 Nov;16(6):207-18. doi: 10.1080/15284336.2015.1123942. Epub 2015 Dec 11.


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.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Anti-HIV Agents / economics*
  • Anti-HIV Agents / therapeutic use*
  • Clinical Trials as Topic
  • Cost-Benefit Analysis*
  • Drug Costs
  • Drugs, Generic / economics*
  • HIV Infections / drug therapy*
  • HIV Infections / epidemiology*
  • Humans
  • Models, Economic
  • United States / epidemiology


  • Anti-HIV Agents
  • Drugs, Generic