The Sixth Annual Payers’ Guide to New FDA Approvals

March 2015, Vol 8, Sixth Annual Payers' Guide - FDA Approvals, Payers' Guide
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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 a preview of some of the key trends in the 2015 drug pipeline. This 2015 edition represents the sixth 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, new combinations of previously approved drugs—an important feature that is increasing in importance in drug research and development—as well as important new or expanded indications, some for drugs approved only a couple of months earlier for the first time. The goal of this special feature is to provide a practical, detailed, and evidence-based resource for medical and pharmacy directors to guide their benefit design decision-making process.

In 2014, the FDA reached an 18-year high in drug approvals totaling 41 NMEs or new biologic pharmaceuticals, the highest number since 1996. This new edition of the Guide includes in-depth updates on 23 new drugs, including 20 drugs approved in 2014 and 3 approvals in early 2015.

In his introduction to this edition, “New FDA Drug Approvals Hit an 18-Year High in 2014” (page 15), Dr Owens reflects on some of the key regulatory trends that were seen this past year in the FDA approval process, such as expanding the accelerated approval of new and promising drugs and the increasing number of orphan drugs coming to market; some of these trends are being carried into 2015.

This is followed by the “FDA Approvals of Brand-Name Prescription Drugs in 2014” (page 22), listing all NMEs and biologic license applications approved by the FDA in 2014, as well as the long list of all new indications, combinations, formulations, dosage forms, and new vaccines added to the pharmaceutical options in 2014.

In lieu of the thorough review of key drugs in the 2015 pipeline, this edition of the Guide provides for the first time a review of early trends in the FDA approvals in 2015. Mr Branning’s article, “Once-Fatal Conditions Have Become Chronic: Early Trends in the FDA’s 2015 Approvals” (page 167), opens a window into the new drugs coming into market in 2015. In addition, 3 in-depth updates are provided for new drugs or indications approved by the FDA in the first quarter of 2015. A more in-depth article on the oncology/hematology pipeline will be provided in a future issue of the journal.

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 and patient care.

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

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Last modified: July 28, 2015
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