Volume 18, Issue 8, Pages (December 2015)

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Volume 18, Issue 8, Pages 1063-1069 (December 2015) Prospective Benefit-Risk Monitoring of New Drugs for Rapid Assessment of Net Favorability in Electronic Health Care Data Joshua J. Gagne, PharmD, ScD, Katsiaryna Bykov, PharmD, MS, Mehdi Najafzadeh, PhD, Niteesh K. Choudhry, MD, PhD, Diane P. Martin, PhD, Kristijan H. Kahler, PhD, James R. Rogers, BA, BS, Sebastian Schneeweiss, MD, ScD Value in Health Volume 18, Issue 8, Pages 1063-1069 (December 2015) DOI: 10.1016/j.jval.2015.08.011 Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Terms and Conditions

Fig. 1 Prospective benefit-risk monitoring of rofecoxib versus nonselective nonsteroidal anti-inflammatory drugs using number needed to treat and number needed to harm (NNT|NNH). The x-axis is time since market access, and each interval is 3 months in duration. CI, confidence interval. (Color version of figure available online). Value in Health 2015 18, 1063-1069DOI: (10.1016/j.jval.2015.08.011) Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Terms and Conditions

Fig. 2 Prospective benefit-risk monitoring of rofecoxib versus nonselective nonsteroidal anti-inflammatory drugs with incremental net benefit with maximum acceptable risk (INB-MAR). The x-axis is time since market access, and each interval is 3 months in duration. Squares indicate monitoring periods in which the 99% CI excluded the null. CI, confidence interval. (Color version of figure available online). Value in Health 2015 18, 1063-1069DOI: (10.1016/j.jval.2015.08.011) Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Terms and Conditions

Fig. 3 Prospective benefit-risk monitoring of rofecoxib versus nonselective nonsteroidal anti-inflammatory drugs using incremental net benefit with relative-value–adjusted life-years (INB-RVALYs). The x-axis is time since market access, and each interval is 3 months in duration. Squares indicate monitoring periods in which the 99% CI excluded the null. CI, confidence interval. (Color version of figure available online). Value in Health 2015 18, 1063-1069DOI: (10.1016/j.jval.2015.08.011) Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Terms and Conditions

Fig. 4 Prospective benefit-risk monitoring of rofecoxib versus nonselective nonsteroidal anti-inflammatory drugs using incremental net benefit with quality-adjusted life-years (INB-QALYs). The x-axis is time since market access, and each interval is 3 months in duration. Squares indicate monitoring periods in which the 99% CI excluded the null. CI, confidence interval. (Color version of figure available online). Value in Health 2015 18, 1063-1069DOI: (10.1016/j.jval.2015.08.011) Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Terms and Conditions

Fig. 5 Prospective benefit-risk monitoring of prasugrel versus clopidogrel using four benefit-risk assessment metrics. The x-axis is time since market access, and each interval is 3 months in duration. Squares indicate the first monitoring period in which the 99% confidence interval for the metric excluded the null. INB, incremental net benefit; MAR, maximum acceptable risk; NNT|NNH, number needed to treat and number needed to harm; QALY, quality-adjusted life-year; RVALY, relative-value–adjusted life-year. Value in Health 2015 18, 1063-1069DOI: (10.1016/j.jval.2015.08.011) Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Terms and Conditions

Fig. 6 Prospective benefit-risk monitoring of denosumab versus bisphosphonates using four benefit-risk assessment metrics. The x-axis is time since market access, and each interval is 1 month in duration. Squares indicate the first monitoring period in which the 99% confidence interval for the metric excluded the null. INB, incremental net benefit; MAR, maximum acceptable risk; NNT|NNH, number needed to treat and number needed to harm; QALY, quality-adjusted life-year; RVALY, relative-value–adjusted life-year. Value in Health 2015 18, 1063-1069DOI: (10.1016/j.jval.2015.08.011) Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Terms and Conditions