Welsh Government aims to make sure that patients 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; this guidance applies in England and Wales. This means that patients treated by NHS Wales as well as those treated by NHS England will be able to access a medicine if its use is recommended by NICE. 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 and the NHS Wales Joint Commissioning Committee (NWJCC) are usually expected to make a medicine that has been recommended for use available for prescribing within 60-days of NICE publishing the Final Draft Guidance on their website.
The All Wales Medicines Strategy Group (AWMSG) also assess medicines for use in NHS Wales. These are usually medicines that have not been assessed by NICE (or have not been selected for a future NICE assessment) but where a clear clinical need or other benefit to NHS Wales has been identified. The All Wales Therapeutics and Toxicology Centre (AWTTC) identifies licensed and off-label 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 with representation from NHS Wales and members of the public (lay members), will be responsible for deciding whether AWMSG should proceed with the assessment of a licensed or an off-label medicine. The AWMSG Scrutiny Panel will decide on the route of assessment for medicines using pre-defined criteria. These routes include HTA appraisal or a more limited assessment for licensed medicines and the established One Wales Medicines assessment process for off-label medicines. Details about the new AWMSG medicines assessment process, the routes of assessment and their criteria are given in the document AWMSG Medicines Assessment Process for Licensed and Off-label Medicines.
Health boards and NWJCC are usually expected to make a medicine that has been recommended for use by AWMSG available for prescribing within 60-days of Welsh Government ratifying the AWMSG positive recommendation, as outlined in the New Treatment Fund. For off-label medicines, Health Boards and NWJCC are expected to fund the medicine according to the recommendation.
Sometimes a health board may not routinely provide a medicine. This may be because the medicine has not been licensed in the UK for treating a particular condition or the medicine is not recommended for routine use after assessment by either 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 the application and decide on whether the medicine should be funded or not for that individual. More information about the IPFR process is available on this website at https://awttc.nhs.wales/ipfr
Some medicines may not meet the criteria for an assessment by either NICE or AWMSG. In these circumstances individual health boards in Wales can decide whether to add the medicine to their formulary (the official list of medicines that can be prescribed to patients in their area).