14 November 2024
Following a comprehensive review, a number of changes to the All Wales Medicines Strategy Group (AWMSG) process for the assessment of medicines for use in NHS Wales will be implemented from 1 January 2025. This applies to the assessment of both licensed medicines and those to be used off-label (i.e. a medicine prescribed and used outside the terms of its UK Medicines and Healthcare products Regulatory Agency (MHRA) marketing authorisation). The review was in response to the shift in the medicines access landscape and to ensure the AWMSG process meets the needs of the NHS in Wales and supports an ‘All-Wales’ approach to medicine access.
These changes mean that AWMSG will be able to progress assessment of medicines where there is a clearly identified clinical need or benefit to NHS in Wales in terms of service delivery but would usually fall outside the current scope for AWMSG assessment.
Most newly licensed medicines undergo health technology assessment (HTA) by the National Institute for Health and Care Excellence (NICE), the advice from which applies in NHS Wales and therefore would not require assessment by AWMSG. The revised AWMSG assessment process will allow applications for other licensed medicines by the pharmaceutical industry, by healthcare professionals working in NHS Wales and by patient organisations. As per the current One Wales Medicines process, applications for the consideration of off-label medicines can be made by healthcare professionals working in NHS Wales and by patient organisations. The All Wales Therapeutics and Toxicology Centre (AWTTC) will also identify medicines for potential assessment through its established information gathering channels.
A new group, called the AWMSG Scrutiny Panel with representation from NHS Wales and lay members, will be responsible for deciding whether AWMSG should proceed with the assessment of a licensed or an off-label medicine. The AWMSG Scrutiny Panel will prioritise requests and decide on the route of assessment for medicines using pre-defined criteria. These routes include HTA appraisal or a more limited assessment for licensed medicines and the established One Wales Medicines assessment process for off-label medicines.
AWMSG’s two sub-groups: the Licensed One Wales Medicines Assessment Group (LOWMAG), and the One Wales Medicines Assessment Group (OWMAG), will consider all the evidence presented and make a recommendation on whether the medicine should be made routinely available in NHS Wales. LOWMAG replaces the New Medicines Group (NMG), and considers and provides recommendations on medicines that are licensed. OWMAG will continue to consider and provide recommendations on medicines being used for off-label indications. These recommendations are then sent to AWMSG for endorsement and Welsh Government for ratification. Once ratified by Welsh Government, these recommendations will ensure equitable and consistent funding of these medicines across the NHS in Wales.
Details about the new AWMSG medicines assessment process, the routes of assessment and their criteria are given in the document AWMSG Medicines Assessment Process for Licensed and Off-label Medicines
The AWTTC website will be updated to reflect the changes to the AWMSG medicines assessment process when it goes live on 1 January 2025. This will include new forms for the pharmaceutical industry and for clinicians and patient organisations to submit medicines for consideration for assessment.
In the meantime please send any enquiries relating to submissions for medicine appraisal to us at AWTTC@wales.nhs.uk.