Welcome to the Ninth Annual Payers’ Guide to New FDA Approvals

March 2018, Vol 11, Ninth Annual Payers' Guide - FDA Approvals, Payers' Guide
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American Health & Drug Benefits is pleased to bring you the Ninth Annual Payers’ Guide to New FDA Approvals. As in previous years, the goal of this Guide is to offer payers, providers, and other healthcare stakeholders a comprehensive overview of new drugs approved by the US Food and Drug Administration (FDA) in 2017. This practical tool offers a quick yet detailed evidence-based resource for medical and pharmacy directors to guide their benefit design decision-making and the development of drug coverage criteria.

In addition to a complete and detailed list of all the new molecular entities (NMEs) and new biologic licensing applications (BLAs) approved by the FDA in 2017, this Guide provides a comprehensive list of new indications, new formulations, new patient populations, and the full scope of new drug-related approvals in the United States. This year’s Guide introduces a new category—gene therapies—ushering in the new world of gene therapies to the US market.

In the words of FDA Commissioner Scott Gott­lieb, MD, the approval of the first 2 new gene therapies in oncology marked a new milestone in drug development, opening new possibilities for curing disease. “We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer. New technologies such as gene and cell therapies hold out the potential to transform medicine.”

The year 2017 marked a new direction in the FDA’s drug approvals: by intensifying its accelerated review process and priority review, the FDA reached a 21-year high, says Dr Owens in his Introduction to this Guide. A total of 46 NMEs and new BLAs were approved by the FDA in 2017 in all clinical categories—a doubling of the 22 NMEs and BLAs approved in 2016.

By applying its fast track review, through its breakthrough therapy designation and the accelerated and/or priority review pathways to approve many of the new drugs, the FDA allows pharmaceutical companies to continue their research and development of life-saving medications, while giving patients earlier access to these therapies.

New technologies continue to feature prominently in today’s drug development, with the ongoing introduction of new and improved biologic therapies, immunotherapies, and targeted therapies, while simultaneously making use of new testing and screening technologies to match the right patient with the right treatment. Thus the number of first-in-class drugs continues to grow, and many of the new drugs entering the market receive new indications soon after, in quick succession.

As in previous years, a key feature of this Guide is the comprehensive Directory of all the NMEs and BLAs approved by the FDA in 2017, as well as a list of all new indications, combinations, formulations, dosages, dosage forms, patient populations, biosimilars, vaccines, and gene therapies.

This Guide also includes a select sample of comprehensive updates on some of the key new drugs approved by the FDA in 2017, as well as several new and important indications approved in 2017 for drugs already on the market. Many more comprehensive updates of new drugs and new indications are posted online at www.AHDBonline.com, together with the full Guide.

EDITOR’S NOTE: The FDA continues to make changes to the prescribing information of many drugs on an ongoing basis. Every effort has been made to update the information in each drug update and any other sections of this publication based on each drug’s prescribing information up to February 28, 2018. The individual comprehensive drug updates were independently developed by the journal’s editors based on publicly available information. The Publisher is not responsible for any inaccuracies stemming from changes, new approvals, or updates that became available later in the year. Readers are advised to review the prescribing information for any future updates and revisions.

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