Chapter 4: Off-label Prescribing: Overcoming the Reimbursement Barrier

Off-label prescribing: Overcoming the reimbursement barrier Off-label prescribing is the practice of using a medicine for a purpose other than that for which it has been officially approved. Off-label usage takes a variety of forms: departing from the dosing range or duration of therapy, using a medicine in an unapproved combination with another agent, prescribing a drug to patients who belong to populations for which the agent is not approved (notably children), and using the product for unlicensed indications. A drug's initial label is often very narrow, and gaining approval for additional indications can take a long time. Manufacturers are understandably reluctant to conduct expensive clinical trials for new indications on drugs that have lost or will soon lose their patent protection. Furthermore, physicians are often quick to deviate from a new drug's labeling restrictions. Off-label prescribing is frequently prompted by a dearth of effective licensed drugs with which to ...

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