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What is our definition of a specialty drug?
What is
Includes drugs or biologics that are either:
derived from biotechnology processes which use tissue culture, living cells, or cellular enzymes) OR
small molecule oral drugs which are organic compounds and binds to a protein, nucleic acid, or polysaccharide
In general, a Specialty Drug meets two or more of the following criteria:
Targets the underlying disease pathology rather than treating symptoms
Manages complications of disease
Targets conditions that are rare, chronic, and costly
Requires special distribution channel (e.g. restricted access, REMS, etc)
Requires close supervision and monitoring of therapy for safety and effectiveness
Requires close supervision or handling related to the dispensing and fulfillment process
Non-Specialty drug that is used in combination with a specialty drug