The AWMSG assessment process has been updated to better support the aim of improving access to medicines where there is a clinical need or benefit to the NHS in Wales and the people it serves.
Information about the updated process, the routes of assessment for licensed medicines and their criteria is available from the AWMSG medicine assessment routes section of this website. A form for Marketing Authorisation holders to tell us about a licensed medicine that may require assessment by AWMSG will be available from here in mid-January 2025. Submission forms and guidance notes for AWMSG appraisal either by health technology assessment or by limited assessment will published here in February 2025. In the meantime please send any enquiries relating to submissions for medicine appraisal to us at AWTTC@wales.nhs.uk.
Please note that the following products remain outside the remit of AWMSG assessment and include:
- Products without Prescription Only Medicine (POM) status
- Vaccines considered by the Joint Committee on Vaccination and Immunisation
- Products used solely for the acute treatment of poisoning
- Diagnostic agents, medical gases and preparations for fluid and electrolyte imbalances .
- Supportive interventions for surgical procedures, diagnostic procedures or wound management
- Medical devices (i.e. the product does not have a licence as a medicine)
Additionally, medicines in some categories are unlikely to be assessed by AWMSG, although exceptions on a case-by-case basis may be made.
These include:
- Minor licence extension for the treatment of children and adolescents (aged up to 18 years) where the medicine is accepted for use by AWMSG or NICE for the same indication in the adult population – see the AWMSG position statement for paediatric minor licence extensions
- Biosimilar medicines - if NICE or AWMSG advice is available for the reference product for the same indication AWMSG assessment will not be required – see the AWMSG position statement for biosimilar medicines. If no such advice is available, AWMSG will consider the case for appraisal in line with AWMSG medicines assessment criteria.
- Generic/branded generic medicines where there is existing NICE or AWMSG advice recommending use.
- New or alternative formulations of medicines, combinations of medicines or medicines formerly part of a combination now used as monotherapy for the same indication which cost the same or less than the existing medicine. For new formulations costing more, AWMSG will consider the case for appraisal in line with AWMSG medicines assessment criteria.
AWMSG reserves the right to request a submission to assess a medicine in line with the needs of NHS Wales.