Incorporating clinical outcomes and economic consequences into drug formulary decisions: A practical approach

Background: In 1994, Regence BlueShield (Regence), a large non-staff model health plan, adopted guidelines governing the review of new and existing dr ug products. However, certain limitations were apparent: adequate data were not available in a timely fashion; unpublished studies and information on unapproved indications were difficult to obtain; data addressing humanistic and economic outcomes were not routinely supplied by manufacturers; and th e time required by Regence staff clinical pharmacists to assemble and summa rize published clinical studies for the pharmacy and therapeutics (P&T) com mittee was excessive; Objective: To describe the process used by Regence to collect and review cl inical, economic, and other health outcomes data as part of the plan's drug formulary adoption process. Process Description: To address these limitations, Regence revised its proc ess to require pharmaceutical manufacturers to submit a detailed dossier wi th clinical and economic data from published and unpublished studies, along with a disease-based economic model projecting the potential impact that i ntroducing the product would have on health outcomes and economic consequen ces occurring across the entire Regence system. After performing independen t literature reviews to ensure the accuracy and comprehensiveness of the in formation obtained, clinical pharmacists at Regence complete a detailed sum mary of each drug for the P&T committee. Conclusion: The new process has addressed the limitations of the previous s ystem and, by improving the timeliness and relevance of available informati on, it supports Regence's goal of maintaining an evidence-based formulary.