The Licensed One Wales Medicines Assessment Group (LOWMAG) replaces the former New Medicines Group (NMG) and provides recommendations to AWMSG on new and existing licensed medicines. LOWMAG considers evidence of cost-effectiveness, clinical effectiveness, and the budget impact presented in AWTTC’s assessment report. LOWMAG also takes into account any wider societal issues, equity of access and considers the views given by clinicians and patients. LOWMAG provides a clear and robust recommendation, with rationale, to AWMSG. AWMSG is asked to endorse the LOWMAG recommendation, which is then considered by Welsh Government for ratification.
Representatives from the MA holder are invited to attend the LOWMAG meeting to observe proceedings and answer any questions that members may have about the evidence submitted.
Clinical experts are invited to attend the LOWMAG meeting to observe proceedings, answer questions and join in discussions to help group members to better understand the clinical context. Clinical experts are usually nominated by their specialist group or network and are not expected to express their personal opinion or promote the use of a medicine.
A patient organisation representative is also invited to attend the LOWMAG meeting to observe proceedings, answer questions and join in discussions to help group members gain a better understanding of the patient and carer perspective. A lay member of LOWMAG will verbally summarise the views of patients received by AWTTC.
Clinical experts and patient organisation representatives are asked to declare any personal or non-specific interests. They and the MA holder representatives will leave the meeting before LOWMAG makes its decision. A LOWMAG recommendation may be:
LOWMAG may defer a recommendation pending a request for further information. LOWMAG will agree start and stop criteria for treatment, if appropriate.
LOWMAG may issue an interim positive recommendation on condition that outcome data are collected to inform a full HTA at the end of the interim period.
The LOWMAG recommendation and decision rationale is shared with the MA holder for comment before being tabled at a subsequent AWMSG meeting.
LOWMAG meets monthly or as needed for optimum timeliness. LOWMAG members include representatives from Health Boards and Trusts in NHS Wales, the pharmaceutical industry and the public ('lay' members). The LOWMAG Constitution, including current membership, and meeting minutes are available from https://awttc.nhs.wales/about-us1/our-committees/#LOWMAG
The One Wales Medicines Assessment Group (OWMAG), provides recommendations to AWMSG on off-label medicines. OWMAG considers the available evidence of cost-effectiveness, clinical effectiveness, and the budget impact presented in AWTTC’s assessment report. OWMAG also takes into account any wider societal issues, equity of access and considers the views given by clinicians and patients. OWMAG provides a clear and robust recommendation, with rationale, to AWMSG. AWMSG is asked to endorse the OWMAG recommendation, which is then considered by Welsh Government for ratification.
Clinical experts are invited to attend the OWMAG meeting to observe proceedings, answer questions and join in discussions to help group members to better understand the clinical context. Clinical experts are usually nominated by their specialist group or network and are not expected to express their personal opinion or promote the use of a medicine.
AWTTC will invite a representative of a patient organisation to attend the OWMAG meeting to observe proceedings, answer questions and join in discussions to help group members gain a better understanding of the patient and carer perspective. A lay member of OWMAG will verbally summarise the views of patients received by AWTTC.
Clinical expert and patient organisation representatives are asked to declare any personal or non-specific interests and will leave the meeting before OWMAG makes its recommendation.
OWMAG makes interim recommendations in accordance with relevant guidance on off-label medicines. These recommendations may be:
OWMAG may defer a recommendation pending a request for further information. OWMAG will agree start and stop criteria for treatment, if appropriate.
The OWMAG recommendation and decision rationale is shared with the MA holder for comment before being tabled at a subsequent AWMSG meeting.
Because OWMAG recommendations are interim, OWMAG reviews all recommendations after the first 12 months, and then every 1 to 3 years. See Section 9.2 for information.
OWMAG meets monthly or as needed for optimum timeliness. OWMAG members are representatives from all IPFR panels in Wales (if possible), the public ('lay' members) and the pharmaceutical industry. The OWMAG Constitution, including current membership and meeting minutes, are available at: https://awttc.nhs.wales/OWMAG