AWMSG launches new process for appraising medicines licensed for use in children

In December 2020 the All Wales Medicines Strategy Group (AWMSG) endorsed a new process for appraising medicines that have had their licence extended to include use in children and young people under 18 years. It is anticipated that the simplified process will result in improved access to licensed medicines for children and adolescents in Wales.

Medicines that meet all of the following criteria will be considered by AWMSG under the new process:

• the licence extension must be for use of the medicine in patients aged under 18 years
• the medicine has been accepted for use in adults (aged 18 years and older) by AWMSG or NICE; and that advice or guidance must still apply
• the licence extension must match the adult indication that was accepted for use by AWMSG or NICE, in every respect except for the target age group of patients.

When the criteria are met, AWTTC prepares an assessment and draft recommendation for consideration by AWMSG. Medicines appraised under the new process are not considered by the New Medicines Group. This and other changes to the process mean that a recommendation is likely to be obtained quicker than for full or limited submissions. Further details of the new process can be found on the AWMSG website.

The first medicine to meet the criteria for the new process was considered at the AWMSG meeting on 10 March 2021. AWMSG recommended lurasidone (Latuda^®) for the treatment of schizophrenia in adolescents aged 13 years to 17 years. Lurasidone had been recommended since 2015 for the treatment of schizophrenia in adults. The most recent advice from AWMSG has been approved by Welsh Government, extending the use of lurasidone to a younger population.