The FDA has been particularly busy with the specialty drug pipeline the last couple of years. Consequently, payers have been spending a good amount of time analyzing these drugs in order to determine their benefit design strategies.
In 2011, two new hepatitis C oral drugs seemed to get the bulk of the chatter surrounding the specialty pharma pipeline. In addition, the FDA approved a drug for lupus — the first OK’d for that condition in more than 50 years — as well as two oncology drugs that it approved concurrently with a companion diagnostic test.
Over the past year, the FDA approved a slew of oncology therapies, as well as numerous drugs to treat HIV. A drug to treat cystic fibrosis made approval headlines, as did the second oral multiple sclerosis drug and the first oral treatment for rheumatoid arthritis.
Some conditions that may see new specialty approvals in 2013 are metastatic melanoma and multiple sclerosis. What else do you expect to see next year as far as specialty drug approvals?