Welsh Government aims to make sure that people in Wales have quick and fair access to medicines. These are the main ways that medicines are approved for use in NHS Wales.
Most newly licensed medicines undergo health technology assessment (HTA) by the National Institute for Health and Care Excellence (NICE). The HTA process carefully considers the clinical evidence, which shows how well the medicine works and how safe it is, and the cost-effectiveness evidence, which shows how well it works in relation to much it costs the NHS. NICE will then publish guidance on whether the medicine is recommended for use in the NHS.
NICE's guidance applies in England and Wales. This means that when NICE recommends a medicine for use, patients treated by NHS Wales will be able to access it as well patients treated by NHS England. More information about NICE assessment processes is available at https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance
The New Treatment Fund, launched by Welsh Government in January 2017, ensures patients across Wales have faster access to new medicines. This means that health boards in Wales and the NHS Wales Joint Commissioning Committee (NWJCC) are usually expected to make a medicine available for prescribing within 60-days of NICE publishing Final Draft Guidance that recommends the medicine for use.
The All Wales Medicines Strategy Group (AWMSG) assess medicines for use in NHS Wales. These are usually medicines that NICE has not assessed (or that have not been selected for a future NICE assessment) but where a clear clinical need or other benefit to NHS Wales is identified. The All Wales Therapeutics and Toxicology Centre (AWTTC) identifies licensed medicines and off-label uses of medicines that are likely to need assessment by AWMSG. This is done through direct evidence gathering by AWTTC, or by evidence submission or request for assessment from stakeholders including: the pharmaceutical industry, healthcare professionals, patient organisations and commissioning organisations.
The AWMSG Scrutiny Panel has representation from NHS Wales and members of the public (lay members) and will decide if AWMSG should proceed with the assessment of a licensed medicine or a medicine used off-label. The Scrutiny Panel will use pre-defined criteria to decide on the route of assessment for each medicine. These routes include: full HTA or a more limited assessment for licensed medicines, and the established One Wales Medicines assessment process for medicines used off-label. The new AWMSG medicines assessment process, the routes of assessment and the decision criteria are detailed in the document AWMSG Medicines Assessment Process for Licensed and Off-label Medicines.
Health boards in Wales and NWJCC are usually expected to make a medicine available for prescribing within 60-days of Welsh Government ratifying a positive AWMSG recommendation, as outlined in the New Treatment Fund. For medicines used off-label, health boards and NWJCC are expected to fund the medicine according to the ratified AWMSG recommendation.
Sometimes a health board may not routinely provide a medicine. This may be because the medicine has not been licensed in the UK to treat a particular condition or the medicine is not recommended for routine use after assessment by NICE or AWMSG. If a patient and their clinician agree that a medicine that isn’t routinely available would benefit the patient, their clinician can submit an Individual Patient Funding Request (IPFR) asking the health board, or NWJCC to fund the medicine. Each health board and NWJCC has an IPFR panel of healthcare professionals and lay members who will meet to consider each application and decide whether to fund the medicine for that patient. More information about the IPFR process is available on this website at https://awttc.nhs.wales/ipfr
If a medicine has been excluded from assessment by NICE or AWMSG, individual health boards in Wales may consider adding the medicine to their formulary (the official list of medicines that can be prescribed to patients in their area).