Health Outcomes Modeling to Quantify Benefit-Risk Tradeoffs: A Case Study Using Rosiglitazone
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*James Cross, Genentech/School of Pharmacy, University of Washington  JS Gardner, School of Pharmacy, University of Washington  LP Garrison, School of Pharmacy, University of Washington  DL Veenstra, School of Pharmacy, University of Washington 


Introduction: Health outcomes modeling of benefit-risk tradeoffs is a potential regulatory decision aid. We quantified the incremental net benefit of rosiglitazone at the time of approval (1999) for montherapy and advisory committee review (2007). Methods: We adapted a commercial Markov model to estimate net benefit of diabetes monotherapy using various data. Results: With 1999 data, rosiglitazone was projected to extend life by a mean of 0.639 years (0.373 quality-adjusted life years) versus placebo, but shorten life by 0.312 years (0.173 QALYs) versus glyburide. Uncertainty in HbA1c reduction had greater impact on the benefit-risk profile than uncertainty in harm. By 2007, rosiglitazone was projected to add 0.222 years (0.091 QALYs) and 0.026 years (0.009 QALYs) versus glyburide or metformin. Conclusions: Modeling offered new interpretations on rosiglitazone’s tradeoffs.