SMC and AWMSG: how HTA for new medicines works in Scotland and Wales, and how it differs from NICE

Three systems, not one

Health is devolved, and medicines access across Great Britain reflects that. The Scottish Medicines Consortium (SMC), part of Healthcare Improvement Scotland, provides advice to NHSScotland on the value of every newly licensed medicine, including new formulations and new indications of established medicines. Before a medicine can be prescribed routinely in Scotland, it has to be accepted for use by SMC.^[1] NICE technology appraisals do not substitute for this. Since 1 October 2017, Healthcare Improvement Scotland no longer assesses NICE multiple technology appraisals for applicability in Scotland, and new medicines in that process that SMC has not assessed require an SMC submission.^[2]

Wales works differently. NICE advice applies in NHS Wales, so most newly licensed medicines are assessed by NICE and do not need separate Welsh assessment. The All Wales Medicines Strategy Group (AWMSG), supported by the All Wales Therapeutics and Toxicology Centre (AWTTC), covers licensed medicines that NICE does not assess, as well as certain off-label uses.^[3]

For a company planning a UK launch, the practical consequence is that Scotland is always a separate submission, and Wales occasionally is.

The SMC submission and decision process

A company may submit to SMC once it has a positive opinion from the Committee for Medicinal Products for Human Use, or up to two months before final approval from the Medicines and Healthcare products Regulatory Agency (MHRA).^[4] SMC's process guide, updated in October 2026, sets out the stages.^[5]

• Assessment team: Each full submission is reviewed by a pharmacist, a health economist, a health services researcher and a lead assessor from the New Drugs Committee (NDC). Companies are often asked for clarification or additional economic analyses before NDC, sometimes within tight timescales.
• New Drugs Committee: A technical committee of around 20 members that meets in private, reviews the evidence and issues preliminary advice in a Detailed Advice Document. The company has 10 working days to comment, and may submit a new or revised patient access scheme (PAS) at that point.
• SMC Executive or SMC Committee: Positive NDC recommendations go to the SMC Executive; negative ones go to the SMC Committee of around 25 members, including representatives of all 14 NHS boards, health economists, public partners and industry. The Committee takes a broader view than NDC, including patient group submissions and PACE output, and votes by simple majority in closed session.
• Publication: The company and NHS boards are informed in confidence, and advice is published on the SMC website four weeks after the meeting.

The usual timeline is 18 weeks from scheduling to advice. A longer timeline, usually 26 weeks, applies to end-of-life and orphan medicines that need a PACE meeting, medicines with a complex PAS, and occasionally complex submissions.^[5] SMC can decide that a medicine is accepted, accepted with restrictions, or not recommended, and it can also accept some medicines on an interim basis.^[5]

Several features have no exact NICE equivalent:

• Non-submission advice: Where a company does not submit, SMC issues "not recommended" advice, which is a common reason for non-recommendation.^[1]
• Abbreviated submissions: Available for some medicines where a full submission is not required because net budget impact is low.^[5]
• Fast-track resubmission: If the only change is a new or improved simple PAS or a confirmed list price reduction, a resubmission within three months of the original decision can go directly to the SMC Committee, usually within 14 weeks, without NDC review.^[5]
• Independent review panel: Where a company disagrees with a decision and has no new data or analyses, it can request an independent review up to 12 months after publication.^[5]

SMC methods and modifiers

SMC's reference case is close to NICE's but not identical. The base case uses a patient perspective on outcomes, with a patient and carer perspective as additional analysis where relevant. Costs are those of NHSScotland and social work (personal social services). Cost-utility analysis is preferred, EQ-5D reported directly by patients is the preferred measure of health-related quality of life, valued using a representative UK sample, and costs and benefits are discounted at 3.5% a year. The comparator is the treatment most likely to be displaced in NHSScotland.^[6]

Two procedural differences have real consequences. First, SMC does not offer pre-submission scoping to define the decision problem; the company defines the population and comparators itself.^[6] Second, where comparators carry a confidential PAS or national contract price, the company must provide a model in which SMC can enter those prices, or else present results against each comparator across a 5% to 95% discount range in 5% steps.^[6] SMC's budget impact template covers the remainder of the launch financial year and two further full financial years.^[6]

Modifiers

SMC states that it has no formal cost per QALY threshold and that the cost per QALY is only part of a wider judgement of value. It may accept more uncertainty, or a higher cost per QALY, where modifiers apply.^[5]

• Greater uncertainty may be accepted for orphan medicines, defined using the MHRA criterion of a prevalence of no more than 5 in 10,000, applied to the full licensed indication.
• A higher cost per QALY may be accepted with evidence of a substantial improvement in life expectancy (normally a median gain of three months, judged in clinical context), a substantial improvement in quality of life, a targetable subgroup with extra benefit, an absence of other proven therapeutic options provided by the NHS, possible bridging to a definitive therapy, or a licensed alternative to an established unlicensed product.

SMC is explicit that modifiers are only applied to a relatively high cost per QALY when the committee is satisfied that the clinical and economic case is robust.^[5] Unlike NICE's severity modifier, these are qualitative factors. There is no QALY weight to calculate.

PACE: end-of-life and orphan medicines

The Patient and Clinician Engagement (PACE) process applies to medicines for end-of-life conditions and orphan or orphan-equivalent conditions. SMC defines an end-of-life medicine as one used to treat a condition at a stage that usually leads to death within three years with currently available treatments, and this may be based on a justified sub-population. Orphan status uses a GB orphan designation, or an equivalent population size of fewer than 2,500 people in 5 million, and is based on the full licensed population.^[7]

If preliminary NDC advice is "not recommended" and the submission requested PACE, SMC convenes a virtual meeting chaired by an NDC or SMC vice-chair, with patient group representatives, clinicians from the relevant specialty and an SMC public partner. The company can submit a brief statement. The resulting PACE statement describes added benefits that may not be fully captured in the conventional assessment, such as effects on work, education, independence and dignity, impacts on carers, and clinical issues including unmet need and severity. SMC describes the PACE output as a major factor in its decision.^{[5, 7]} If a PACE-eligible medicine is still not accepted, a resubmission within six months of the PACE meeting can reuse the original statement.^[5]

In practice

PACE is a mechanism for evidence that the economic model cannot hold, not a substitute for a credible model. It works best when patient groups and clinicians have been engaged early and the company's own case is already robust and transparent about uncertainty.

Ultra-orphan pathway and interim acceptance

The ultra-orphan pathway

A medicine qualifies as ultra-orphan only if all four criteria are met: the condition has a prevalence of 1 in 50,000 or less in Scotland; the medicine has GB orphan designation at marketing authorisation; the condition is chronic and severely disabling; and it requires highly specialised management.^[7] Companies are encouraged to seek validation early; SMC aims to confirm status within around eight weeks, and validation expires after two years.^[8]

Once validated, and subject to three Scottish Government conditions (a full submission, a PAS on terms acceptable to the Patient Access Scheme Assessment Group, and data collection that meets the pathway's requirements), the medicine can be prescribed while further evidence is generated.^[5] SMC's website describes this as availability for a period of up to three years.^[8] SMC conducts an initial assessment using a broader framework covering the nature of the condition, the impact of the medicine, value for money, impact beyond direct health benefits and on specialist services, and NHS and social services costs. No decision on routine use is made at that stage.^[5]

The company must provide a full updated submission within three months of the end of the evidence generation period. At reassessment, a PACE meeting is convened if NDC's preliminary advice is negative, and SMC then decides on routine use. Patients already benefiting continue treatment if the medicine is not recommended.^[5]

Interim acceptance

Medicines with a UK conditional marketing authorisation are eligible for an interim acceptance decision, as are some medicines in the Innovative Licensing and Access Pathway or with a positive Early Access to Medicines Scheme opinion. SMC may issue interim acceptance if the confirmatory data are expected to address the key uncertainties. Voting is in two stages: if the first vote is to not recommend, a second vote considers interim acceptance.^[5]

There is a limit, however. If a key weakness is that the plausible ICER is higher than SMC generally accepts, additional efficacy or safety data are unlikely to resolve it.^[5] Interim acceptance addresses evidence immaturity, not price. A reassessment, with a new PAS application, is required when the conditional authorisation converts to a standard authorisation, typically after two to three years.^[5]

Patient access schemes in Scotland

PAS proposals in Scotland are assessed by the Patient Access Scheme Assessment Group (PASAG), which operates separately from SMC. SMC only considers the financial benefit of a PAS once PASAG has accepted it for use in Scotland.^[5] Companies should submit a PAS alongside the SMC submission, with a second opportunity within two weeks of preliminary NDC advice, although a late PAS may extend timelines.^[5] A PAS is a condition of the ultra-orphan pathway.^[5] Standard terms published in January 2020 apply to PAS submissions from March 2020, with updated terms included in application forms from December 2025.^[2]

Commercially, the practical point is that a PAS agreed for England does not automatically operate in Scotland. It needs its own PASAG approval, and complex schemes take longer.

Wales: AWMSG, AWTTC and the gaps NICE leaves

Remit relative to NICE

AWMSG's remit was extended in 2010 to all new medicines not on NICE's 12-month work programme.^[9] The current routing criteria, introduced in January 2025, expect most licensed medicines to go through NICE. AWMSG may assess a licensed medicine where it is not on the NICE technology appraisal or highly specialised technologies work programme, where the NICE appraisal has been terminated, or where the commercial arrangement in the NICE advice does not apply to NHS Wales. A medicine with negative NICE advice can be considered only if the company submits additional evidence showing added value to NHS Wales.^[10] The AWMSG submission form makes the same point: NICE advice usually applies in Wales, including negative or terminated advice.^[11]

Process

Under the process in force since January 2025, the AWMSG Scrutiny Panel decides whether to assess a medicine and which route to use: full HTA, interim HTA or limited assessment.^{[3, 10]} The Licensed One Wales Medicines Assessment Group (LOWMAG), which replaced the New Medicines Group, reviews the evidence and makes a recommendation; AWMSG is asked to endorse it; and Welsh Government ratifies it as AWMSG advice. Off-label medicines follow the One Wales route through a parallel group.^{[3, 12]}

Interim HTA is used where data collection is needed to reduce uncertainty. The company commits to an updated submission once data are collected, a commercial arrangement for supply at reduced cost is required, and the outcome is time limited and subject to regular review.^[12] Once AWMSG advice is ratified, health boards and trusts are expected to fund the medicine, with availability no later than 60 calendar days after ratification, provided any commercial arrangement is in place.^[12] Welsh Government directions under the New Treatment Fund set a parallel expectation of availability within no more than two months of publication of a NICE appraisal or a ratified AWMSG recommendation.^[13]

Commercial arrangements

Historically, Wales used its own Wales Patient Access Scheme (WPAS), and existing arrangements may still take that form.^{[9, 14]} Commercial arrangements are now framed as a PAS or a Commercial Access Agreement (CAA), approved by the Commercial Arrangement Scheme Wales Group (CASWG), an AWMSG sub-committee. Implementation is supported by a Commercial Medicines Access Team drawn from AWTTC, NHS Wales Shared Services Partnership and the Medicines Value Unit.^[15] For NICE-evaluated products, NHS Wales aligns commercial agreements with NHS England, but separate commercial engagement for Wales is still required.^[15] For AWMSG assessments, commercial arrangements should be agreed by CASWG before assessment proceeds, and medicines without one are asked to consider a simple discount.^[14]

Methods

AWMSG has aligned its methods with NICE. In 2023 it removed its end-of-life modifier and introduced a severity modifier, and updated its very rare disease policy to align with NICE's highly specialised technologies criteria.^[16] Its current severity policy, dated December 2025, uses the same QALY weights as NICE and cites the NICE manual.^[17] AWMSG budget impact estimates cover each of the first five years after introduction, and companies must test comparator discounts of 5% to 95% where a comparator has a confidential arrangement.^[11]

How SMC and AWMSG differ from NICE

Sources: NICE manual and threshold announcements;^{[18, 19, 20]} SMC guidance;^{[5, 6]} AWTTC and AWMSG documents.^{[10, 11, 12, 17]}

Worked example: a QALY-shortfall weight

Under AWMSG's severity policy, absolute shortfall is the expected remaining QALYs of the age- and sex-matched general population minus those expected with the condition on current treatment; proportional shortfall is the absolute shortfall divided by the general population figure. Both use a 3.5% discount rate. A weight of 1.2 applies for an absolute shortfall of 12 to 18 or a proportional shortfall of 0.85 to 0.95; a weight of 1.7 applies at 18 or more, or 0.95 or more. Where the two measures disagree, the more severe applies.^[17]

• General population expected remaining QALYs: 12.0. Expected with the condition on current care: 1.2.
• Absolute shortfall: 12.0 − 1.2 = 10.8 (below 12, weight 1.0).
• Proportional shortfall: 10.8 / 12.0 = 0.90 (within 0.85 to 0.95, weight 1.2).
• The more severe measure applies, so the weight is 1.2.
• With an incremental cost of £30,000 and 0.80 incremental QALYs, the unweighted ICER is £37,500 per QALY. Weighted, it is 30,000 / (0.80 × 1.2) = £31,250 per QALY.

The same medicine in Scotland would carry no QALY weight. Its case would rest on whether SMC's qualitative modifiers apply and, if it is end-of-life or orphan, on PACE. A model built for NICE and AWMSG should therefore report the unweighted ICER prominently, because that is the number SMC will see.

Thresholds

The government increased NICE's standard threshold range from £20,000 to £30,000 per QALY to £25,000 to £35,000 per QALY, applied from April 2026 to new and ongoing appraisals; the HST range was not changed.^{[19, 20]} We have not found published statements from SMC or AWMSG adopting a numerical range, and SMC continues to state that it has no formal threshold. We would not assume automatic read-across.

What this means for evidence planning

• Plan Scotland as a full, separate submission: SMC will issue advice on every new medicine within remit, and a non-submission produces "not recommended" advice. Build the SMC submission timeline into launch sequencing from the start.
• Define the Scottish decision problem yourself: Without scoping, the comparator is the treatment most likely to be displaced in NHSScotland. Validate this with Scottish clinicians rather than assuming the NICE scope applies.
• Make the model SMC-ready: Allow entry of confidential comparator prices, present patient-only and patient-plus-carer perspectives where relevant, and report unweighted ICERs.
• Decide early on PACE, ultra-orphan or interim routes: End-of-life and orphan eligibility must be claimed in the submission, ultra-orphan validation takes around eight weeks, and interim acceptance depends on the regulatory route. Each changes the evidence strategy.
• Prepare a PASAG application in parallel: A PAS submitted with the initial SMC submission avoids extended timelines.
• Check AWMSG relevance whenever NICE will not appraise: If a medicine or indication is not on NICE's work programme, or a NICE appraisal is terminated, AWMSG may be the route to national access in Wales. Engage AWTTC and CASWG early.
• Use one core model, three configurations: A well-structured model can switch between NICE, SMC and AWMSG settings for perspective, weighting, comparators, budget impact horizon and commercial inputs. That is cheaper and more consistent than three separate builds.

How Evidaxia can help

Evidaxia supports NICE, SMC and AWMSG submissions, including PACE preparation, ultra-orphan and interim acceptance strategy, PAS and commercial arrangement analyses, and clarification responses. We also adapt core and NICE models for Scotland and Wales. See HTA submissions in the UK and model adaptation.

References

1. Scottish Medicines Consortium. A guide to the Scottish Medicines Consortium [Internet]. Edinburgh: Healthcare Improvement Scotland; 2023 [cited 2026 Oct 30]. Available from: https://scottishmedicines.org.uk/media/7605/20231818-a-guide-to-the-scottish-medicines-consortium.pdf
2. Scottish Medicines Consortium. Patient access schemes [Internet]. Glasgow: Scottish Medicines Consortium; [date unknown] [cited 2026 Oct]. Available from: https://scottishmedicines.org.uk/making-a-submission/companies/patient-access-schemes/
3. All Wales Therapeutics and Toxicology Centre. Updated AWMSG medicine assessment process to launch in January 2025 [Internet]. Cardiff: All Wales Therapeutics and Toxicology Centre; 2024 Nov 14 [cited 2026 Oct 30]. Available from: https://awttc.nhs.wales/news-meetings-and-events/news1/updated-awmsg-medicine-assessment-process-to-launch-in-january-2025/
4. Scottish Medicines Consortium. Making a submission [Internet]. Glasgow: Scottish Medicines Consortium; [date unknown] [cited 2026 Oct]. Available from: https://scottishmedicines.org.uk/making-a-submission/
5. Scottish Medicines Consortium. Process guide for submitting companies, version 1.0 [Internet]. Edinburgh: Healthcare Improvement Scotland; 2026 Oct [cited 2026 Oct 30]. Available from: https://scottishmedicines.org.uk/media/10769/20261022-smc-process-guide-for-submitting-companies-v10.pdf
6. Scottish Medicines Consortium. Guidance to submitting companies for completion of New Product Assessment Form (NPAF) [Internet]. Edinburgh: Healthcare Improvement Scotland; 2026 Oct [cited 2026 Oct 30]. Available from: https://scottishmedicines.org.uk/media/10768/20261021-guidance-to-submitting-companies-for-completion-of-npaf.pdf
7. Scottish Medicines Consortium. Patient and Clinician Engagement (PACE) meetings overview, version 4.0 [Internet]. Glasgow: Scottish Medicines Consortium; [date unknown] [cited 2026 Oct 30]. Available from: https://scottishmedicines.org.uk/media/8998/pace-overview-v40.pdf
8. Scottish Medicines Consortium. Ultra-orphan medicines for extremely rare conditions [Internet]. Glasgow: Scottish Medicines Consortium; [date unknown] [cited 2026 Oct]. Available from: https://www.scottishmedicines.org.uk/how-we-decide/ultra-orphan-medicines-for-extremely-rare-conditions/
9. Varnava A, Bracchi R, Samuels K, Hughes DA, Routledge PA, et al. New medicines in Wales: the All Wales Medicines Strategy Group (AWMSG) appraisal process and outcomes. PharmacoEconomics. 2018;36(5):613-24. Available from: https://link.springer.com/article/10.1007/s40273-018-0632-7
10. All Wales Therapeutics and Toxicology Centre. Routing medicines for AWMSG assessment [Internet]. Cardiff: All Wales Therapeutics and Toxicology Centre; [date unknown] [cited 2026 Oct]. Available from: https://awttc.nhs.wales/accessing-medicines/awmsg-medicines-assessment-process-for-licensed-and-off-label-medicines/2-routing-medicines-for-awmsg-assessment/
11. All Wales Therapeutics and Toxicology Centre. Submission form for AWMSG health technology assessment [Internet]. Cardiff: All Wales Therapeutics and Toxicology Centre; 2025 Jun [cited 2026 Oct 30]. Available from: https://awttc.nhs.wales/accessing-medicines/pharmaceutical-industry/industry-submission-forms-new-process/hta-submission-form-final-june-2025/
12. All Wales Therapeutics and Toxicology Centre. The AWMSG Licensed One Wales Medicines Assessment process [Internet]. Cardiff: All Wales Therapeutics and Toxicology Centre; 2026 Jul [cited 2026 Oct 30]. Available from: https://awttc.nhs.wales/accessing-medicines/medicines-assessment-policy-documents/the-awmsg-licensed-one-wales-medicines-assessment-process/
13. Welsh Government. New Treatment Fund: directions on the exemptions for health boards and trusts (WHC/2024/020) [Internet]. Cardiff: Welsh Government; 2024 [cited 2026 Oct 30]. Available from: https://www.gov.wales/node/61600
14. All Wales Therapeutics and Toxicology Centre. AWMSG assessment process [Internet]. Cardiff: All Wales Therapeutics and Toxicology Centre; [date unknown] [cited 2026 Oct]. Available from: https://awttc.nhs.wales/accessing-medicines/awmsg-medicines-assessment-process-for-licensed-and-off-label-medicines/3-awmsg-assessment-process/
15. All Wales Therapeutics and Toxicology Centre. Submit a commercial arrangement to the NHS in Wales [Internet]. Cardiff: All Wales Therapeutics and Toxicology Centre; [date unknown] [cited 2026 Oct]. Available from: https://awttc.nhs.wales/accessing-medicines/submit-a-commercial-arrangement-to-the-nhs-in-wales/
16. All Wales Therapeutics and Toxicology Centre. AWTTC has [Internet]. Cardiff: All Wales Therapeutics and Toxicology Centre; 2023 May 9 [cited 2026 Oct 30]. Available from: https://awttc.nhs.wales/news-meetings-and-events/news1/awttc-has-updated-its-health-technology-assessment-hta-methods-and-processes/
17. All Wales Medicines Strategy Group. Policy for appraising medicines for severe conditions [Internet]. Cardiff: All Wales Therapeutics and Toxicology Centre; 2025 Dec [cited 2026 Oct 30]. Available from: https://awttc.nhs.wales/files/pre-2025-appraisal-process-documents-archive/policy-for-appraising-medicines-for-severe-conditions-pdf-75kb/
18. National Institute for Health and Care Excellence. NICE health technology evaluations: the manual (PMG36), section 4: economic evaluation [Internet]. London: National Institute for Health and Care Excellence; [date unknown] [cited 2026 Oct]. Available from: https://www.nice.org.uk/process/pmg36/chapter/economic-evaluation
19. National Institute for Health and Care Excellence. Changes to NICE's cost-effectiveness thresholds confirmed [Internet]. London: National Institute for Health and Care Excellence; 2025 Dec 1 [cited 2026 Oct 30]. Available from: https://www.nice.org.uk/news/articles/changes-to-nice-s-cost-effectiveness-thresholds-confirmed
20. National Institute for Health and Care Excellence. Changes to NICE's cost-effectiveness thresholds: frequently asked questions [Internet]. London: National Institute for Health and Care Excellence; [date unknown] [cited 2026 Oct]. Available from: https://www.nice.org.uk/what-nice-does/faqs/changes-to-nice-s-cost-effectiveness-thresholds

Sources accessed October 2026. This article is analysis for information and is not legal, regulatory or tax advice.