FOREWORD
Welcome to the Seventh Annual Payers’ Guide to New FDA Approvals American Health & Drug Benefits publishes a Payers’ Guide to New FDA Approvals annually with the goal of providing payers and other healthcare stakeholders a comprehensive review of pharmaceuticals that were newly approved or that received important new indications by the US Food and Drug Administration (FDA) in the previous year. The current 2016 edition represents the seventh year of publication of this Guide by the Journal. This special feature was first published in 2010. This year’s Guide includes updates on many of the new drugs that were approved in 2015 and have either been recently launched or are soon to be launched; this includes new molecular entities (NMEs), new biologics, new combinations of previously approved drugs (an increasing trend in FDA approvals), and important new or expanded indications, some of which were for drugs approved for the first time only a couple of months earlier. This year’s edition of the Guide includes in-depth updates on 20 novel drugs and new indications approved in 2015. In 2015, the FDA reached a new high in drug approvals, totaling 45 NMEs or novel biologic pharmaceuticals compared with 41 approvals the year before. 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. In his introduction to this edition, “The Year 2015 Had Highest Number of Drug Approvals in the New Millennium, but with Controversy” (page 19), Dr Owens reflects on some of the key regulatory trends that were seen in 2015, such as the 16 first-in-class novel drugs, an exceptionally large number of new types of drugs entering the market. Acknowledging the good news with the growing number of drugs becoming available for patients with various diseases, especially with the introduction of pharmaceuticals with novel mechanisms of action and new formulations, Dr Owens points out that cost remains a major burden for specialty drugs, as well as for novel small-molecule drugs entering the market, a concern that is not lost on any healthcare stakeholder today. This is followed by a directory of all of the NMEs and biologic license applications added to the phar-
18
l
American Health & Drug Benefits
l
maceutical options in 2015, as well as an extensive list of all the new indications, combinations, formulations, dosages, dosage forms, and vaccines, as well as the first-ever biosimilar approved by the FDA. In particular, 2015 was a watershed year for new pharmaceuticals and novel drug classes that have joined the drug armamentarium for multiple myeloma. Therefore, this year’s Guide includes “Therapeutic Leap for Multiple Myeloma in 2015: Unprecedented FDA Drug Approvals” (page 36), a review of these exciting developments, with comments from top myeloma experts on the implications of these events for patients and for all stakeholders. With so many new options entering the market, it is easy to agree with Dr Rajkumar of the Mayo Clinic in Rochester, who describes 2015 as “a revolutionary time in multiple myeloma,” noting that most patients now live 4 years or more “largely because of the plethora of new agents” (page 36), adding, “We have to thank the FDA for approving these drugs so rapidly.” Agreeing with these comments, Dr Richardson, of Dana-Farber Cancer Institute in Boston, notes, “This is an extraordinary moment in oncology”—echoing the excitement among myeloma experts worldwide. This edition of the Guide also includes a review of the anticipated FDA approvals in 2016 in rheumatoid arthritis and in other autoimmune conditions, especially psoriasis and psoriatic arthritis. Mr Branning’s article titled “Competition Heats Up in Rheumatoid Arthritis and Other Autoimmune Conditions” (page 155) is focused on the expected arrival of several biosimilars for arthritis and other autoimmune conditions based on the impending patent expiration dates for many of the top agents in these disease states. American Health & Drug Benefits will continue to provide this Guide in the coming years to offer healthcare stakeholders a tool for applying up-todate information on new pharmaceuticals into their benefit design decisions and patient care. We welcome your feedback and suggestions. Send any comments to [email protected]. This Guide is also available online at www.AHDB online.com.
www.AHDBonline.com
Vol 9
l
Special Feature
l
March 2016
Welcome to the Seventh Annual Payers’ Guide to New FDA Approvals American Health & Drug Benefits publishes a Payers’ Guide to New FDA Approvals annually with the goal of providing payers and other healthcare stakeholders a comprehensive review of pharmaceuticals that were newly approved or that received important new indications by the US Food and Drug Administration (FDA) in the previous year. The current 2016 edition represents the seventh year of publication of this Guide by the Journal. This special feature was first published in 2010. This year’s Guide includes updates on many of the new drugs that were approved in 2015 and have either been recently launched or are soon to be launched; this includes new molecular entities (NMEs), new biologics, new combinations of previously approved drugs (an increasing trend in FDA approvals), and important new or expanded indications, some of which were for drugs approved for the first time only a couple of months earlier. This year’s edition of the Guide includes in-depth updates on 20 novel drugs and new indications approved in 2015. In 2015, the FDA reached a new high in drug approvals, totaling 45 NMEs or novel biologic pharmaceuticals compared with 41 approvals the year before. 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. In his introduction to this edition, “The Year 2015 Had Highest Number of Drug Approvals in the New Millennium, but with Controversy” (page 19), Dr Owens reflects on some of the key regulatory trends that were seen in 2015, such as the 16 first-in-class novel drugs, an exceptionally large number of new types of drugs entering the market. Acknowledging the good news with the growing number of drugs becoming available for patients with various diseases, especially with the introduction of pharmaceuticals with novel mechanisms of action and new formulations, Dr Owens points out that cost remains a major burden for specialty drugs, as well as for novel small-molecule drugs entering the market, a concern that is not lost on any healthcare stakeholder today. This is followed by a directory of all of the NMEs and biologic license applications added to the phar-
18
l
American Health & Drug Benefits
l
maceutical options in 2015, as well as an extensive list of all the new indications, combinations, formulations, dosages, dosage forms, and vaccines, as well as the first-ever biosimilar approved by the FDA. In particular, 2015 was a watershed year for new pharmaceuticals and novel drug classes that have joined the drug armamentarium for multiple myeloma. Therefore, this year’s Guide includes “Therapeutic Leap for Multiple Myeloma in 2015: Unprecedented FDA Drug Approvals” (page 36), a review of these exciting developments, with comments from top myeloma experts on the implications of these events for patients and for all stakeholders. With so many new options entering the market, it is easy to agree with Dr Rajkumar of the Mayo Clinic in Rochester, who describes 2015 as “a revolutionary time in multiple myeloma,” noting that most patients now live 4 years or more “largely because of the plethora of new agents” (page 36), adding, “We have to thank the FDA for approving these drugs so rapidly.” Agreeing with these comments, Dr Richardson, of Dana-Farber Cancer Institute in Boston, notes, “This is an extraordinary moment in oncology”—echoing the excitement among myeloma experts worldwide. This edition of the Guide also includes a review of the anticipated FDA approvals in 2016 in rheumatoid arthritis and in other autoimmune conditions, especially psoriasis and psoriatic arthritis. Mr Branning’s article titled “Competition Heats Up in Rheumatoid Arthritis and Other Autoimmune Conditions” (page 155) is focused on the expected arrival of several biosimilars for arthritis and other autoimmune conditions based on the impending patent expiration dates for many of the top agents in these disease states. American Health & Drug Benefits will continue to provide this Guide in the coming years to offer healthcare stakeholders a tool for applying up-todate information on new pharmaceuticals into their benefit design decisions and patient care. We welcome your feedback and suggestions. Send any comments to [email protected]. This Guide is also available online at www.AHDB online.com.
www.AHDBonline.com
Vol 9
l
Special Feature
l
March 2016
