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]
^Cite error: The named reference CMS_strategy_2004 was invoked but never defined (see the help page).
^Feder, Barnaby J. (25 January 1988). "Kodak's Diversification Plan Moves Into a Higher Gear". New York Times. Retrieved 17 October 2015.
^ abcdefgCite error: The named reference ncbi_2013 was invoked but never defined (see the help page).
^ abcdeCite error: The named reference magellanrx_2015 was invoked but never defined (see the help page).
^ abcdThomas, Kate; Pollack, Andrew (15 July 2015). "Specialty Pharmacies Proliferate, Along With Questions". New York Times. Sinking Spring, Pa. Retrieved 5 October 2015.
^Cite error: The named reference workforce.com was invoked but never defined (see the help page).
^Cite error: The named reference FAS was invoked but never defined (see the help page).
^"Diplomat expands hepatitis C specialty services with acquisition of Burman's Specialty Pharmacy". PRNewswire. Flint, Michigan. 19 June 2015. Retrieved 5 October 2015.
^"The Growing Cost of Specialty Pharmacy-Is it Sustainable?". The American Journal of Managed Care. 18 February 2013. Archived from the original on 26 October 2017. Retrieved 23 January 2016.
^ abKober, Scott (July 2008). "The Evolution of Specialty Pharmacy". Biotechnology Healthcare. 5 (2): 50–51. PMC 2706163. PMID 22478714.
^ ab"Specialty Drugs and Health Care Costs". The Pew Charitable Trusts. 16 November 2015. Retrieved 29 February 2016.
^"Centers for Medicare & Medicaid Services, Announcement of Calendar Year (CY) 2018 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter and Request for Information (2017)" (PDF), CMS, 3 April 2017, retrieved 12 January 2018
^Herper, Matthew (19 February 2010), "The World's Most Expensive Drugs", Forbes, retrieved 25 June 2015
^Chelsey Dulaney (May 6, 2015). "Alexion to Buy Synageva for $8.4 Billion". The Wall Street Journal. Retrieved May 7, 2015.
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