A Year of Dominance Behind, a Year of Dominance Ahead

AFTER AN HISTORIC 2015, the specialty pharmaceutical landscape is poised for an encore performance in the year ahead. Last year saw the FDA give the green light to 45 new novel drugs, which represents the highest total of approvals since the Prescription Drug User Fee Act was passed in 1992.

What is especially noteworthy about these approvals is the dominance of specialty medications, which comprise nearly half of these new agents. Boiling these numbers down even further shows 25 new treatments for rare diseases and 13 for oncology, which illustrates the growing niche that specialty pharmacy is carving across the landscape of patient care.

An underlying positive that can be gleaned from these figures is the less arduous approval process by the FDA for medications that show significant promise or address an unmet clinical need. A recent report by Diplomat found that of the new drugs approved in 2015, 60% were granted at least one special designation by the FDA, which include breakthrough, fast track, accelerated approval, and priority review.

This expedited process helps get these new therapies into the hands of patients where they are so desperately needed. As we look forward to the road ahead, 2016 looks to be another whirlwind, with approximately 25 new specialty drugs awaiting an FDA decision within the first 2 quarters of the year.

Of these treatments, obeticholic acid for a number of chronic liver diseases, alectinib and brigatinib for lung cancer, and velpatasvir for hepatitis C loom large, in addition to potential new therapies for Duchenne muscular dystrophy.

With a robust pipeline bursting at the seams with specialty drugs, I urge you to stay on top of the next wave of approvals with the latest article from Aimee Tharaldson, PharmD, of Express Scripts, which highlights some of the significant drugs that may be approved in early 2016.

Also in this issue is the second of an extensive 2-part review of the specialty drugs approved in 2015, written by Stacey Ness PharmD, RPh, CSP, MSCS, AAHIVP, and Ruby Mhajan, RPh, of Managed Health Care Associates, Inc. The unfortunate by-product of the escalating cost for specialty drugs have been the barriers placed in front of the patients seeking to access these therapies.

With that in mind, Specialty Pharmacy Times Editorial Board member and Curant Health COO, Marc O’Connor, offers his insight on how specialty pharmacy can serve as a conduit between payors and manufacturers in a collaborative effort that breaks down the walls for patients in need.

Staying on top of the latest developments in the specialty landscape is our mission in the print edition of Specialty Pharmacy Times and our daily news web site, www.SpecialtyPharmacyTimes.com, which keeps you abreast of all the latest news you need to know. Follow our coverage in print, online, in our e-newsletters, and on mobile devices. SPT

Thank you for reading!

Mike Hennessy, Sr

Chairman and CEO