AWTTC usually reviews positive (including positive with restrictions) recommendations for licensed medicines 3 years after publication. The review looks for any significant new evidence or information published that is likely to affect the current AWMSG advice. If any is found, further investigation or reassessment of the recommendation may be appropriate. After their first review, recommendations may be assigned:
All interim positive recommendations for licensed medicines will have a specified end date. In advance of this, it is likely that the MA holder will be asked to submit evidence to support a full HTA by NICE or AWMSG, so that a final recommendation on whether the treatment should continue to be routinely funded in NHS Wales can be made.
If the MA holder fails to make a timely submission to AWMSG or NICE for HTA, the interim positive recommendation may be withdrawn. People having treatment may continue to do so, until they and their NHS clinician consider it appropriate to stop. AWTTC will inform AWMSG when the interim recommendation is withdrawn. On endorsement by AWMSG, AWTTC will forward this information to Welsh Government for ratification.
OWMAG reviews all recommendations for off-label medicines 12 months after they are first published, and then every 1 to 3 years thereafter. The reviews consider any new evidence and patient outcome data (if available).
After the review, OWMAG may decide to:
If OWMAG recommend that a re-assessment is needed, the full process for assessing an off-label medicine is followed (see Section 3). If OWMAG renew, discontinue or retire the recommendation, the decision will be forwarded to AWMSG for noting, and then sent to Welsh Government for ratification.
AWTTC conducts a short internal review for recommendations in years where no OWMAG review is scheduled. If new evidence is identified that may affect the current recommendation, AWTTC advises OWMAG that a full review should be prioritised ahead of the planned schedule.
Recommendations may be discontinued if the medicine has received UK marketing authorisation (MA) for the indication, or if an alternative licensed medicine becomes routinely available (funded) for the same group of patients. If an MA is granted the MA holder will be expected to progress the medicine through the usual routes for licensed medicines.
If the medicine receives marketing authorisation for the indication under which it is recommended and the MA holder fails to make a timely (usually within 12 months of licence) submission to AWMSG or NICE for HTA, the interim recommendation for off-label use may be withdrawn. People receiving treatment may continue to do so, until they and their NHS clinician consider it appropriate to stop. AWTTC will inform AWMSG that the recommendation is withdrawn and will forward this information to Welsh Government for ratification.
Advice for an off-label medicine may also be retired if, for example, national guidance endorses the routine off-label use of the medicine for the same indication or specified patient group. The availability of this medicine in NHS Wales will not be affected by retirement of the recommendation. AWTTC will inform AWMSG that the recommendation is retired and will forward the information to Welsh Government for ratification.