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

March 2019, Vol 12, Tenth Annual Payers' Guide - FDA Approvals, Payers' Guide
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American Health & Drug Benefits is pleased to bring you the Tenth Annual Payers’ Guide to New FDA Approvals. As has now become a tradition of this publication, the goal of this Guide is to offer payers, providers, Pharmacy & Therapeutics committees, and other healthcare stakeholders an overview of the novel pharmaceuticals approved by the US Food and Drug Administration (FDA) in 2018.

As noted in the introduction to the oncology overview article, 2018 was a record year for the FDA in terms of the number of new molecular entities (NMEs) and new biologic license applications (BLAs) approved, totaling 59 drugs overall, compared with the 46 approved in 2017 and only 22 in 2016. Furthermore, of the 59 drugs approved in 2018, 19 represent first-in-class medicines. Developing novel classes of medicines for new diseases means new treatment options for many patients, especially those with rare diseases.

Indeed, of the novel NMEs and BLAs, 34 (58%) drugs were designated as orphan drugs, which may not necessarily be blockbusters, but they may bring new hope for patients who previously had no treatment option. The detailed list of new drugs in this Guide illustrates the breadth of this trend.

In 2018, the FDA continued its efforts to expedite the approval process, with 43 of the 59 (73%) new drugs designated for a priority review and 24 (41%) approved using its fast track designation. By contrast, only 4 (7%) drugs were approved under the accelerated approval procedure based on preliminary data that requires further review when more mature data are available for a full approval. This low amount of accelerated approvals may indicate enhanced caution exercised by the FDA in bringing new therapies to the market. In addition, the FDA granted its important breakthrough therapy designation to 14 (24%) of the new drugs approved in 2018—another mechanism used to enhance patient access to novel therapies.

In addition to a complete and detailed listing of all novel NMEs and BLAs, as well as the 7 new bio­similars approved in 2018, this Guide also provides a comprehensive and detailed overview of the new indications for oncology drugs approved in 2018 for therapies that were previously available on the market for other indications, with 17 oncology drugs receiving new indications, some for 2 different types of cancer.

This practical Guide offers a quick, evidence­based resource for medical and pharmacy directors to Guide their benefit design decision-making and the development of formulary and other drug coverage criteria.

As in previous years, this Guide includes a select sample of comprehensive updates on some of the key new drugs approved by the FDA in 2018, as well as several new and important indications approved in 2018 for drugs already on the market.

We hope you find this publication a useful tool for applying up-to-date information on new pharmaceuticals into benefit design decisions and patient care.


EDITOR’S NOTE: The FDA continues to make changes to the prescribing information of many drugs on an ongoing basis. The information in this Guide is based on each drug’s prescribing information up to January 15, 2019. The Publisher and the Editors are not responsible for any inaccuracies stemming from labeling changes, new approvals, or company updates that became available after that date. Readers are advised to review the most recent prescribing information for any future updates and revisions.

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Last modified: August 30, 2021