Pharmacoeconomic Evaluations: Guidelines for Drug Purchasers

OBJECTIVE: To propose a set of guidelines for use by health care organizations in the United States that seek useful, comparative clinical information and economic analysis on pharmaceutical products to make sound drug purchasing decisions. PRACTICE INNOVATION: Based on a therapy intervention approach, the guidelines provide a structured framework to help managed care purchasers become more consistent in how they evaluate drug products for inclusion in the formulary. The guidelines factor in the need to examine the impact of new drug products on overall costs within the entire health system. PRACTICE SETTING: Intended for use by managed care organizations in the U.S. that purchase prescription drugs. INTERVENTION: Not applicable. MAIN OUTCOME MEASURE: Not applicable. RESULTS: The guidelines provide MCOs with a new systematic approach for identifying the overall cost and clinical outcomes impact of drug therapies. The guidelines are designed to take into account the characteristics of the patient population being treated and the fact that patients generally are redistributed among different treatment categories once a new drug product is introduced, thus offering MCOs an analysis model that extends beyond the traditional partial cost-outcomes approach. Emphasis is placed on looking at the cost-outomes impact of a new drug or therapy within a systems or disease area framework in which the redistribution of patients between therapy options is explicitly modelled. The guidelines specify that the following information elements be used in pharmacoeonomic analysis: product description, place in therapy, comparator products, therapy intervention framework, supporting clinical data, supporting pharmacoeconomic data, system impact assessments—costs—outcomes, overall assessment, and bibliography and supporting materials.