![]() 1 The proliferation of specialty products poses a unique challenge, since it is estimated that these products will soon represent 50% of pharmacy costs. ![]() The financial impact of these new products is considerable, contributing in part to a 12.2% increase in national prescription drug spending in 2014-the largest increase since 2002. This is in part because of a flood of new, effective, and often expensive interventions that require careful analysis for developing and managing a viable pharmacy benefit. The role of the pharmacist in managed care settings has evolved considerably in recent years. No conflicts of interest, financial or otherwise, were reported. Committee members reviewed and provided feedback on the final draft. The Format provides a framework to support these critical interactions related to product value by facilitating an evidence-based, transparent approach.ĭISCLOSURES: This document was prepared by Jeff Lee, PharmD, FCCP, on behalf of the AMCP Format Executive Committee. The evolving health care landscape will require new levels of collaboration and communication among key stakeholders to successfully navigate the challenges of this new environment. The Format should be used as a framework for ongoing evidence-based dialogue between manufacturers and payers. Version 4.0 has been modified to improve the usability of the Format, with clarifying guidance related to logistical considerations such as a recommended time frame for implementation of Version 4.0, as well as dossier updates and ongoing communication between manufacturers and health care decision makers. It also includes new guidance related to emerging special topic considerations such as biosimilars, specialty pharmacy products, and companion diagnostic tests. Version 4.0, developed by pharmacists from health plan, manufacturer, and academic perspectives, provides updated recommendations on acquiring and evaluating clinical and economic evidence to inform formulary and medical policy decisions. The AMCP Format for Formulary Submissions, Version 4.0, is the next iteration of the Format, which was first released in 2000. As prescription drug spending soars, and new effective, but expensive drugs rush to the market, pharmacists and other health care decision makers must evaluate a myriad of important clinical and economic considerations in determining the relative value and, subsequently, the appropriate placement of a product within a formulary. ![]() Managed care pharmacists are increasingly presented with complex considerations related to prescription drug formulary management. ![]()
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