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THE PHARMA REVIEW (MAY - JUNE 2011)

Pharmacoeconomics and Outcomes Research: An Overview

Dr. Robert A Freeeman and Dr.Rajat Sethi

Abstract: Pharmacoeconomics is a set of population-based, analytic methods employed to assess the comparative economic efficiencies of two or more alternative drug therapies that produce similar health outcomes: clinical efficacy, effectiveness in clinical practice, resource utilization and humanistic or social. Outcomes research is a broad term that describes studying the effects of drugs in patient populations or population sub-groups Economic efficiency is defined as a comparison of the how resources are consumed in achieving a common outcome. Clinical efficacy and effectiveness outcomes differ in that the former is a clinical endpoint obtained from a randomized clinical trial and the latter is the outcome found in actual clinical practice, or the “real world” where the environment is not defined by the requirements of clinical trials or studies. Finally, a humanistic or social outcome is an endpoint that is measured by health-related quality of life scalar changes, by changes in patient health status or by patient preferences for or satisfaction with specific therapeutic interventions.
 

Pharmacoeconomics and Outcomes Research Defined
The basic question pharmacoeconomics attempts to answer is which treatment option is the better (or best, for more than two options) use of scare resources to achieve a therapeutic outcome? A pharmacoeconomic assessment provides an approximation to the broader question of “What differential value for money are we obtaining from this drug?, and to the more specific question of “Should we provide coverage and reimbursement for this drug at this price based on its relative value in therapy?”
Implicit in considering these questions is that one is assessing a new technology that is being compared to standard therapeutic options, which includes standard therapy (often the market leader) and in some instances, no therapy when none is available. Although most published pharmacoeconomic studies examine the incremental value of new drugs, pharmacoeconomics is often applied to examine existing therapeutic choices within a therapeutic class. And, comparisons may be drug vs. drugW, drug vs. procedure, drug vs. device or drug vs. “no treatment”. The selection of the comparator technology is critical to the validity of the analysis as are the selections of dosages, indications, duration of therapy and patient populations.
The specific questions address by pharmacoeconomics research depends on the decision-maker. Decision-makers may be categorized as follows:

 

 

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