AWMSG will no longer routinely appraise a medicine with a 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.
In these circumstances Health Boards should continue to add paediatric licence extensions to their formularies. This update to the AWMSG process aims to improve access to medicines for children, ensuring they can be made available as soon as is practically possible and aligns with NHS England and NHS Scotland.
AWMSG will no longer expect to routinely receive a submission for a paediatric minor licence extension; however, should the need arise (such as inequity of access in Wales, or uncertainty in the evidence base), then AWMSG reserves the right to appraise a medicine where there is a clear clinical need.
The National Institute for Health and Care Excellence (NICE) and the All Wales Medicines Strategy Group (AWMSG) have a shared interest in the drive to improve patient access to new medicines and treatments. A memorandum of understanding exists which formally sets out a collaboration between NICE and AWMSG.
NICE has been reviewing its processes and methodology for appraising antimicrobials. Whilst this review by NICE was ongoing, AWMSG accepted submissions for the appraisal of antimicrobials to ensure advice continued to be available in NHS Wales. However, at its April 2022 meeting, AWMSG decided to suspend the appraisal of antimicrobials from Friday, 29th April 2022 until such time that AWMSG has considered the new NICE methodology. Recognising the importance of antimicrobial stewardship, for an individual patient the prescribing of antimicrobials not previously appraised or not previously recommended by AWMSG (or NICE) should be done in consultation with a microbiologist and the patient and/or guardian or carer, and based on the best available evidence. In such an emergency clinical circumstance, following microbiologist advice, access to an antimicrobial will not be denied or delayed.
AWMSG retains the right to request a submission for appraisal of any antimicrobial medicine, when directed by the AWMSG Steering Committee.
AWMSG does not usually appraise biosimilar medicines.
Existing health technology assessment (HTA) advice for the ‘reference’ medicine, published by AWMSG or the National Institute for Health and Care Excellence (NICE), will automatically apply for biosimilar medicines licensed for the same indication and in the same population as the ‘reference’ medicine. Without advice for the ‘reference’ product, a biosimilar medicine is not endorsed for use within NHS Wales.
The marketing authorisation holder of the ‘reference’ or biosimilar medicine is encouraged to engage with AWMSG when there is negative HTA advice or in the absence of advice.
AWMSG reserves the right to request a submission for appraisal of any biological medicine, when directed by the AWMSG Steering Committee.
We expect that the majority of cell therapies and gene therapies will be appraised by NICE. With the exception of those cell and gene therapies submitted for appraisal by NICE, AWMSG will appraise cell and gene therapies for patients living in Wales if the therapy has been classified as a medicinal product.