Clinical Therapeutics
Vol 35 | No. 4 | April 2013 | Pages 351-540
http://www.clinicaltherapeutics.com/current

Editorial
Showcasing Pharmaceutical Economics, Outcomes, and Health Policy: An Update in Clinical Therapeutics
Denys T. Lau, PhD
http://www.clinicaltherapeutics.com/article/S0149-2918%2813%2900108-2/fulltext

Excerpt
Sound scientific evidence is in demand as part of health care decision making to demonstrate the effectiveness, quality, and safety of health care services, particularly pharmacotherapies, in real-world, routine clinical settings. As health care spending continues to rise, empirical analyses of costs and the relative value of treatment alternatives have gained prominence in informing prescribing and reimbursement decisions, while scrutiny over their analytical approaches for scientific rigor also has increased. In light of the continuing need for better evidence-based medicine, this special issue of Clinical Therapeutics showcases a collection of diverse, yet related, articles addressing the current state and future issues on pharmaceutical economics, treatment utilization, health outcomes, and drug-related health policy.

Despite the abundance of published health economic evaluations in recent decades, the International Society of Pharmacoeconomics and Outcomes Research Task Force on Quality Improvement in Cost-Effectiveness Research (chaired by Don Husereau) has found no guidelines, requirements, or checklists on health economic research. Along with several other peer-reviewed scientific journals, Clinical Therapeutics is co-publishing the society’s task force report on the Consolidated Health Economic Evaluation Reporting Standards, a checklist and explanatory guidance document that is intended to help improve the reporting of health economic evaluations. (10.1016/j.clinthera.2013.03.003)…

Comparative-Effectiveness Research to Aid Population Decision Making by Relating Clinical Outcomes and Quality-Adjusted Life Years
Jonathan D. Campbell, PhD, Judy Zerzan, MD, MPH; Louis P. Garrison Jr., PhD; Anne M. Libby, PhD
http://www.clinicaltherapeutics.com/article/S0149-2918%2813%2900067-2/abstract

Abstract 
Background
Comparative-effectiveness research (CER) at the population level is missing standardized approaches to quantify and weigh interventions in terms of their clinical risks, benefits, and uncertainty.

Objectives
We proposed an adapted CER framework for population decision making, provided example displays of the outputs, and discussed the implications for population decision makers.

Methods
Building on decision-analytical modeling but excluding cost, we proposed a 2-step approach to CER that explicitly compared interventions in terms of clinical risks and benefits and linked this evidence to the quality-adjusted life year (QALY). The first step was a traditional intervention-specific evidence synthesis of risks and benefits. The second step was a decision-analytical model to simulate intervention-specific progression of disease over an appropriate time. The output was the ability to compare and quantitatively link clinical outcomes with QALYs.

Conclusions
The outputs from these CER models include clinical risks, benefits, and QALYs over flexible and relevant time horizons. This approach yields an explicit, structured, and consistent quantitative framework to weigh all relevant clinical measures. Population decision makers can use this modeling framework and QALYs to aid in their judgment of the individual and collective risks and benefits of the alternatives over time. Future research should study effective communication of these domains for stakeholders.