Specialty drug category grows with new approvals

Specialty pharmaceutical research and development spending is expected to increase with the focus on "biobetters" (eg, new dosage forms, better frequencies, targeted therapies), biosimilars, and novel therapies, according to a presentation at the Academy of Managed Care Pharmacy's 2011 Educational Conference, in Atlanta.

Specialty therapy classes such as rheumatoid arthritis (RA), have grown from 4 (2004) to 9 agents; multiple sclerosis (MS) from 4 (2004) to 8 agents; renal cell carcinoma from 0 (2004) to 6 agents; and hereditary angioedema from 0 (2004) to 4 agents.

"FDA has been approving larger numbers of specialty medications," according to Aimee Tharaldson, PharmD, senior clinical consultant of Emerging Therapeutics at Express Scripts, a pharmacy benefit manager in Bloomington, Minn. "In 2010, they approved twice as many specialty medications as traditional [14 versus 7]. So far this year, they have approved 15 specialty medications; 5 more may be approved before the end of the year. Based on the current pipeline, 2012 will be a significant year for specialty approvals."

Current leading classes are still inflammatory conditions, MS, and oncology. Oral anti-inflammatory biologics will compete with anti-TNF agents. More "biobetters" and agents for refractory gout may be available. Pipeline oral anti-inflammatory agents include apremilast (psoriasis, psoriatic arthritis) and the new Janus kinase inhibitor, tofacitinib (RA, psoriasis). Pipeline oral MS drugs include dimethyl fumarate/BG-12, teriflunomide, and laquinimod, as well as injectable alemtuzumab. The HCV pipeline is robust with more than 20 products, including more oral protease inhibitors, and oral polymerase inhibitors, as well as direct acting antivirals. New for CF is an oral agent VX-770, or ivacaftor (Kalydeco), which may be the first agent approved to treat the underlying disease.