How Welsh medicines appraisal works
Most licensed medicines go through NICE, and NICE technology appraisal guidance applies in NHS Wales. The All Wales Medicines Strategy Group (AWMSG) fills the gaps: since 2002 it has appraised medicines outside the NICE work programme, or where early appraisal is of benefit. The All Wales Therapeutics and Toxicology Centre (AWTTC) runs the process and writes the assessment.
A revised process started in January 2025. The AWMSG Scrutiny Panel decides whether a medicine needs assessment and which route applies. The Licensed One Wales Medicines Assessment Group (LOWMAG), which replaced the New Medicines Group (NMG), makes the recommendation. AWMSG endorses it and Welsh Government ratifies it. Health boards are expected to make a positive recommendation available no later than 60 calendar days after ratification. AWMSG advice is usually superseded by any later NICE guidance for the same indication, but it continues to stand if NICE later terminates its appraisal.[1, 2]
LOWMAG can recommend a medicine, recommend it with restrictions, issue an interim positive recommendation or not recommend it, and it may defer a decision pending further information. Company representatives attend LOWMAG to answer questions, alongside clinical experts and a patient organisation representative. If a company does not engage with an assessment AWMSG considers necessary, a Statement of Advice can be issued, which means the medicine is not endorsed for routine use in NHS Wales.
- StartLicensed Medicines Information FormCompany submits[3]
- RouteAWMSG Scrutiny PanelDecides whether assessment is needed and which route: full HTA, interim HTA or limited assessment
- AssessmentAWTTC evidence summaryCompany comments on the draft report within 10 working days
- RecommendationLOWMAGRecommend, restrict, interim positive, or not recommend
- EndorsementAWMSG and Welsh GovernmentAWMSG endorses; Welsh Government ratifies
- Within 60 calendar days of ratificationAvailable in NHS WalesHealth boards are expected to make a positive recommendation available
Assessment routes
| Route | When it applies |
|---|---|
| Full HTA | Significant service or budget impact, and the medicine is not on the NICE TA/HST work programme, NICE advice is significantly delayed or terminated, or the NICE commercial arrangement does not apply in Wales |
| Interim HTA | As above, where data collection is needed to reduce uncertainty and the company commits to an updated submission. A commercial arrangement is required, and the recommendation is time-limited |
| Limited assessment | Not on the NICE work programme, no significant service impact, and for example a small net budget impact, cost saving, standard of care or national commissioning advice elsewhere in the UK |
Medicines previously not recommended by NICE or AWMSG can be reassessed only where there is significant new value for NHS Wales, such as a Wales Patient Access Scheme. Off-label use follows the separate One Wales Medicines process through the One Wales Medicines Assessment Group (OWMAG), which is driven by NHS Wales clinicians and does not accept company requests.
Forms and the submission sequence
A company starts with the Licensed Medicines Information Form. If the Scrutiny Panel decides assessment is needed, AWTTC invites the company to complete either the HTA submission form or the limited assessment form, each with guidance notes, plus the AWTTC budget impact template. AWTTC asks companies not to complete either form until requested. Files are uploaded to AWTTC's secure portal.
Medicines for a very rare disease need eligibility confirmed by AWTTC on a separate form before the HTA form is submitted. Commercial arrangements, including a WPAS, should be agreed by the Commercial Arrangement Scheme Wales Group (CASWG) before an assessment proceeds.
Timelines
AWTTC does not publish a single fixed duration, and appraisal dates are confirmed only once a complete submission has been received. The fixed points are:
- 10 working days to respond if a company disagrees with a Scrutiny Panel decision
- 10 working days to respond to the draft Evidence Summary Report
- 10 days after the AWMSG meeting to request an Independent Review
- Up to 12 weeks more if a Clinician and Patient Involvement Group (CAPIG) meeting is held for a very rare disease medicine
- 60 calendar days from ratification to availability, and review of positive advice usually after 3 years
AWTTC notes that a resubmission could take up to 12 months.
Evidence and methods requirements
The HTA form asks for a cost-utility analysis from the perspective of NHS Wales and personal social services, with Welsh resource use and costs where possible, and Welsh data wherever they exist. Costs and benefits are discounted at 3.5%, with a 1.5% scenario only where fully justified. Utilities use the EQ-5D-3L value set, with 5L data mapped. Comparators must reflect routine practice in NHS Wales, usually supported by Welsh clinicians. Results are reported against £20,000 and £30,000 per QALY, with probabilistic analysis and a five-year Welsh budget impact.
Two policies change the decision frame. The severity policy applies QALY weights of 1.2 or 1.7 based on absolute or proportional QALY shortfall. The very rare disease policy covers conditions affecting no more than 1 in 50,000 people in Wales, with no more than 18 eligible patients, a threshold usually up to £100,000 per QALY and QALY weighting up to 3.
The UK is outside Regulation (EU) 2021/2282, so joint clinical assessment, which applies to new oncology medicines and ATMPs from 12 January 2025, does not apply in Wales. JCA evidence and indirect treatment comparisons can still feed a Welsh submission once matched to NHS Wales practice.
What we deliver
- Licensed Medicines Information Forms and route assessment
- HTA and limited assessment submissions
- Cost-utility models adapted to Welsh costs and data (see model adaptation)
- Budget impact analyses on the AWTTC template
- Severity and very rare disease eligibility cases
- WPAS and discount scenario analysis for CASWG
- Responses to the draft Evidence Summary Report and LOWMAG preparation
What assessors look for
Common problems include using UK or English data where Welsh data exist, and comparators that do not match routine Welsh practice. Models should include a discount field and report results for discounts from 5% to 95% in 5% steps. A commercial arrangement left until late can delay the assessment, because it should be agreed with CASWG before assessment proceeds.
Why Evidaxia
We have supported SMC and AWMSG submissions alongside NICE work, and our founder worked inside NICE as an HTA Technical Lead and Analyst. We check early whether Wales needs its own submission at all, and when it does we build it from the same evidence base as your UK HTA submissions.
References
- All Wales Therapeutics and Toxicology Centre. Updated AWMSG medicine assessment process [Internet]. Cardiff: All Wales Therapeutics and Toxicology Centre; 2025 Jan [cited 2026 Oct]. Available from: https://awttc.nhs.wales/news-meetings-and-events/news1/updated-awmsg-medicine-assessment-process-to-launch-in-january-2025/
- All Wales Therapeutics and Toxicology Centre. The AWMSG Licensed One Wales Medicines Assessment Process [Internet]. Cardiff: All Wales Therapeutics and Toxicology Centre; [date unknown] [cited 2026 Oct]. Available from: https://awttc.nhs.wales/accessing-medicines/medicines-assessment-policy-documents/the-awmsg-licensed-one-wales-medicines-assessment-process/
- All Wales Therapeutics and Toxicology Centre. Submit a medicine for AWMSG assessment [Internet]. Cardiff: All Wales Therapeutics and Toxicology Centre; [date unknown] [cited 2026 Oct]. Available from: https://awttc.nhs.wales/accessing-medicines/submit-a-medicine-for-awmsg-assessment/
Sources reviewed October 2026. Methods and procedures change; check the latest agency guidance before submission.