Tell us about a medicine that may be suitable for AWMSG assessment

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.

Marketing Authorisation holders are invited to complete our Licensed Medicines Information Form [docx, 105KB] to tell us about a licensed or soon-to-be licensed medicine or significant licence extension (e.g. a new indication, a new target group, or a change in the place of therapy) and which may require assessment by AWMSG. The form can also be used to provide AWTTC with information on medicines currently on the NICE work programme as this information will enable AWTTC to support NHS Wales in the implementation of any NICE positive recommendations.

Information submitted on the Licensed Medicines Information Form may be considered by the AWMSG Scrutiny Panel and a decision will be made on whether the medicine is suitable for assessment. If suitable, companies will be invited to complete a submission form for either full or limited assessment. These submission forms plus guidance notes on how to complete the form are available from the Submit a medicine for AWMSG assessment webpage. Please do not complete a full or limited submission form until directed to do so by AWTTC.

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.

If you have any queries about making a submission, please contact AWTTC on 029 218 26900 or email AWTTC@wales.nhs.uk.