Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals[1][2] classified as high-cost,[3][4][5] high complexity and/or high touch.[4] Specialty drugs are often biologics[3][6]—"drugs derived from living cells"[7] that are injectable or infused (although some are oral medications).[4] They are used to treat complex or rare chronic conditions such as cancer, rheumatoid arthritis, hemophilia, H.I.V.[5] psoriasis,[3] inflammatory bowel disease[3] and hepatitis C.[4][8] In 1990 there were 10 specialty drugs on the market,[9] around five years later nearly 30,[10] by 2008 200,[10] and by 2015 300.[11]
Drugs can be defined as specialty because of their high price.[3][4][5] Medicare defines any drug with a negotiated price of $670 per month or more as a specialty drug. These drugs are placed in a specialty tier requiring a higher patient cost sharing.[11][12] Drugs are also identified as specialty when there is a special handling requirement[3] or the drug is only available via a limited distributions network.[3] By 2015 "specialty medications accounted for one-third of all spending on drugs in the United States, up from 19 percent in 2004 and heading toward 50 percent in the next 10 years",[5] according to IMS Health.
According to a 2010 article in Forbes, specialty drugs for rare diseases became more expensive "than anyone imagined" and their success came "at a time when the traditional drug business of selling medicines to the masses" was "in decline".[13] In 2015 analysis by The Wall Street Journal suggested the large premium was due to the perceived value of rare disease treatments which usually are very expensive when compared to treatments for more common diseases.[14]
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