BACKGROUND: In 1994, Regence BlueShield (Regence), a large non-staff model health plan, adopted guidelines governing the review of new and existing drug 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 However, certain limitations were apparent: adequate data were not available in a timely fashion; unpublished studies and information on unapproved indications were difficult to obtain; data addressing humanistic and economic outcomes were not routinely supplied by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 the time required by Regence staff clinical pharmacists to assemble and summarize published clinical studies for the pharmacy and therapeutics (P&T) committee was excessive. OBJECTIVE: To describe the process used by Regence to collect and review clinical, 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 process to require pharmaceutical manufacturers to submit a detailed dossier with clinical and economic data from published and unpublished studies, along with a disease-based economic model projecting the potential impact that introducing the product would have on health outcomes and economic consequences occurring across the entire Regence system. After performing independent literature reviews to ensure the accuracy and comprehensiveness of the information obtained, clinical pharmacists at Regence complete a detailed summary of each drug for the P&T committee. CONCLUSION: The new process has addressed the limitations of the previous system and, by improving the timeliness and relevance of available information, it supports Regence's goal of maintaining an evidence-based formulary.
BACKGROUND: In 1994, Regence BlueShield (Regence), a large non-staff model health plan, adopted guidelines governing the review of new and existing drug 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 However, certain limitations were apparent: adequate data were not available in a timely fashion; unpublished studies and information on unapproved indications were difficult to obtain; data addressing humanistic and economic outcomes were not routinely supplied by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 the time required by Regence staff clinical pharmacists to assemble and summarize published clinical studies for the pharmacy and therapeutics (P&T) committee was excessive. OBJECTIVE: To describe the process used by Regence to collect and review clinical, 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 process to require pharmaceutical manufacturers to submit a detailed dossier with clinical and economic data from published and unpublished studies, along with a disease-based economic model projecting the potential impact that introducing the product would have on health outcomes and economic consequences occurring across the entire Regence system. After performing independent literature reviews to ensure the accuracy and comprehensiveness of the information obtained, clinical pharmacists at Regence complete a detailed summary of each drug for the P&T committee. CONCLUSION: The new process has addressed the limitations of the previous system and, by improving the timeliness and relevance of available information, it supports Regence's goal of maintaining an evidence-based formulary.