Every year about 100 new medicines, or new formulations of medicines, receive a marketing authorisation (licence).
Health technology assessment (HTA) is the preferred and the most common way for the NHS to decide whether the benefit to patients of a new licensed medicine justifies any additional cost for buying and administering it. In Wales, a new licensed medicine may be assessed by the All Wales Medicines Strategy Group (AWMSG) or by the National Institute for Health and Care Excellence (NICE).
NICE's HTA guidance applies in England and Wales. This means that patients in NHS England and NHS Wales will be able to access a new medicine if its use is recommended by a NICE HTA. Health boards in Wales are expected to make a new medicine available to patients within two months of NICE publishing its Final Appraisal Determination (FAD) or Final Evaluation Determination (FED).
AWMSG take NICE's future work programme into account when considering whether to assess a medicine. AWMSG use the same criteria as NICE to assess clinical effectiveness and cost-effectiveness. AWMSG don't usually assess a medicine if NICE will publish its final appraisal of the same medicine within 12 months of the medicine's marketing authorisation date.
When AWMSG assess a medicine through HTA, we (the All Wales Therapeutics and Toxicology Centre (AWTTC)) liaise with clinical experts, patients, carers and patient organisations, and the pharmaceutical industry to collect comprehensive evidence about the medicine.
When AWMSG is deciding whether to recommend a medicine, the views and experiences of patients and healthcare professionals are taken into account. If you would like to input into this process, please see our Work in progress page.
In HTA, the evidence collected is reviewed to make an informed decision on whether a medicine should be routinely available in NHS Wales. If AWMSG recommend a medicine for use, or as an option for use, then their advice is considered by Welsh Government.
Welsh Government will decide whether that medicine should be funded in NHS Wales. If Welsh Government approves (ratifies) AWMSG's advice, the medicine should then be made available to patients in Wales within 60 days of the ratification date.
The whole HTA process takes about six months to ensure that the medicine can be endorsed for NHS Wales as soon as possible after it's licensed in the UK.
Sometimes, NICE will then carry out and publish HTA guidance for a medicine that AWMSG has already assessed. In these cases, NICE's guidance will replace (supersede) AWMSG's advice.
For pharmaceutical companies wishing to submit a medicine for AWMSG appraisal or to find out more about the HTA process, see the Submit for AWMSG appraisal page.
The New Treatment Fund, launched by Welsh Government in January 2017, ensures patients across Wales have faster access to new medicines.
Health boards and trusts have a 60-day deadline to make a newly recommended medicine available for prescribing. In order to monitor compliance with the New Treatment Fund, health boards regularly report how quickly they put the new medicines onto their prescribing lists to Welsh Government.
Annual reports on the formulary status of medicines recommended for use within NHS Wales by NICE and AWMSG are compiled by the All Wales Therapeutics and Toxicology Centre (AWTTC).