In accordance with the New Treatment Fund, launched by Welsh Government in January 2017, the NHS in Wales must fund the medicine and make sure it’s available for prescribing to patients no later than 60 calendar days after ratification of the AWMSG recommendation or publication of a NICE Final Appraisal Determination (FAD) or Final Draft Guidance (FDG).
In order for Welsh Government to monitor compliance with the New treatment Fund, health boards regularly report the time taken to put the new medicines onto their prescribing lists. If the MA holder has offered a commercial arrangement this must be in place before the medicine can be routinely prescribed in NHS Wales.
If Welsh Government ratifies a positive (including positive with restrictions) recommendation, the off-label medicine can be routinely prescribed for patients who meet the starting criteria as set out in the recommendation.
The responsibility associated with prescribing an off-label medicine falls on the prescriber. Prescribers should pay particular attention to the risks associated with using off-label medicines and must discuss the risks and benefits with individual patients, their families and carers. These risks may include: adverse reactions; or problems with the medicine’s information or labelling, for example, potential confusion for a patient or their carers when the Patient Information Leaflet is inconsistent with the licensed use of the medicine. Healthcare professionals should consult their relevant professional guidance on prescribing off-label medicines before they prescribe any off-label or unlicensed medicines.
Licensed and off-label medicines ratified by Welsh Government are available to all eligible patients who are registered with a GP practice in Wales, even if they need to receive their treatment outside Wales.