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By: Decision Resources Inc

In: The SAGE Handbook of Healthcare

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

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Off-label Prescribing: Overcoming the Reimbursement Barrier
Off-label prescribing: Overcoming the reimbursement barrier
Overview

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 ...

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