Specialty pharmacy drives prescription growth
It’s no secret that the category of drugs drawing the most attention — and money — in recent years has been specialty pharmacy. And it shouldn’t be surprising that the growth the category has experienced in the past several years — pushed more recently by hepatitis C and oncology treatments — isn’t expected to slow anytime soon.
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Specialty pharmacy sales growth for the year ended September 2015 rose by 23%, according to IMS Health — far outstripping the 8% sales growth that traditional medicines saw during the same period. This increase in sales is accompanied not just by growth in the amount of healthcare spend, but also by an uptick in the regulatory approval of novel new drugs — a group that is about half composed of products dispensed through specialty pharmacy — in the past several years.
In 2014, the Food and Drug Administration set a record when it approved 41 novel new drugs, in addition to 19 new biologics. But in 2015, the agency surpassed its own record, approving 45 novel new drugs and nine biologics. As Diplomat Pharmacy pointed out in its report on the state of specialty pharmacy, many of the novel new drugs and biologics also receive special designations from the FDA, including orphan designation, fast track, accelerated approval and priority. These designations might be contributing to the boom in specialty drug applications and a focus on their development by manufacturers, according to Diplomat’s emerging therapeutics analyst Ryan Chandanais.
“There are a lot of specialty drugs in the late-stage pipeline right now,” Chandanais said. “I think a lot of it has to do with some of the FDA special designations that are out there helping to move drugs through the development process and the FDA review process more quickly than we used to see. ... The FDA has a history of granting approvals for drugs treating disease states where there are few or no currently available treatments.”
This was certainly the case among several of the agency’s 2015 approvals, including Praxbind, a first-in-class treatment to reverse adverse anticoagulant effects caused by blood-thinner dabigatran; Lonsurf, which treats metastatic colorectal cancer; Yondelis, which treats soft tissue carcinoma; and new cholesterol maintenance injectables Praluent and Repatha, which are the first in a new class of drug called PCSK9 inhibitors.
One disease state that several years ago had few treatments, but now is the one of the main classes of specialty drugs are treatments for hepatitis C. The big news of 2014 was the approval of Harvoni, which in many cases cured a patient’s viral hepatitis. In 2015, Harvoni received a new indication by the FDA, as did Technivie, to treat different genotypes of hepatitis C. Last year also saw the approval of Deklinza, which treats genotype 3 hepatitis C infection. And though the last several years in specialty have been focused on hepatitis, it’s possible another class of drugs will soon be driving growth. Diplomat’s Chandanais already has an idea of what might be next, and when it will happen.
“One [disease] I’ve been watching is nonalcoholic steatohepatitis or NASH,” he said. “That’s a disease state where I’ve read studies saying anywhere from about 2% to 5% of the U.S. population has some degree of it, and currently there are no available therapies for it.”
Diplomat expected that the first likely treatment for NASH — fatty liver disease among patients who don’t have a history of alcoholism — will be approved this year, but for a different illness — primary biliary cirrhosis. As a result, the first drug indicated to treat NASH could launch in 2017. Beside NASH treatments, Chandanais noted that PCSK9 inhibitors also could be poised for growth.
“You also might see an eventual uptick in the hypercholesterolemia drugs that we had approved in the last year when they get some of their outcomes study results,” he said. “If those are positive, I think you might see uptick in those drugs at that time, too.”