Foreward - The Fifth Annual Payers’ Guide to New FDA Approvals

A Payers’ Guide to New FDA Approvals is published annually by American Health & Drug Benefits to offer payers and other healthcare stakeholders a detailed analysis of new drugs approved by the US Food and Drug Administration (FDA) in the previous year, as well as an overview of the key drugs in the pharmaceutical pipeline. The 2014 edition represents the fifth year of publication of this Guide by American Health & Drug Benefits. This special feature was first published in 2010.

This year’s Guide includes in-depth updates on many of the new drugs that have either recently been launched or are soon to be launched, including new molecular entities (NMEs), new biologics, and important new or expanded indications, providing a practical, detailed resource for medical and pharmacy directors to guide their benefit design decision-making process.

Each edition has expanded the scope of the drug updates coverage, as well as the review of new FDA approvals. The 2014 edition includes in-depth updates on 29 of the drugs that had received FDA approval in 2013. This edition also includes a detailed introduction, “New FDA Drug Approvals in 2013” (page 13), reflecting on some of the key trends that were evident in the FDA approval process in 2013, and which may carry into 2014.

Also included is a comprehensive review of all NMEs and biologic license applications approved in 2013, as well as the new combinations, formulations, and indications added to the therapeutic options in 2013 “FDA Approvals of Brand-Name Prescription Drugs in 2013” (page 16). A pipeline article titled “Specialty Drugs Top the Trends in the 2014 Pipeline” (page 33) features key players in the current pharmaceutical pipeline, highlighting the major clinical categories in drug development and key trends in pharmaceutical research and development. The role of specialty drugs and the number of orphan drugs approved by the FDA remain 2 of the main trends that continue to dominate the market.

American Health & Drug Benefits will continue to provide this Guide in the coming years to offer healthcare stakeholders a tool for applying up-to-date information on new pharmaceuticals into their benefit design decisions.

We welcome your feedback and suggestions. Send any comments to This email address is being protected from spambots. You need JavaScript enabled to view it.. This Guide is also available online at www.AHDBonline.com.