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Will unlicensed or off-label medicines be considered?

Yes, where a clearly defined cohort of potential patients has been described, the One Wales Medicines process may consider the following options:

  • the medicine is not licensed for any indication; OR
  • the medicine is not licensed for the indication of interest; OR
  • the requested use of the medicine is outside of accepted treatment pathway i.e. the specific sequence of treatment/s has not been approved by NICE/AWMSG,

However there must be no suitably licensed medicine available that will meet the patients’ needs.

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