How HTA in Scotland works
The Scottish Medicines Consortium (SMC), part of Healthcare Improvement Scotland, advises NHS boards and their Area Drug and Therapeutics Committees on newly licensed prescription-only medicines, new formulations and new indications. NICE guidance does not apply in Scotland, and since October 2017 NICE multiple technology appraisals are no longer assessed for applicability to NHSScotland, so medicines need their own SMC submission.
Assessment runs in two stages. The New Drugs Committee (NDC), around 20 clinicians, pharmacists, nurses and industry members, completes the technical assessment in private and issues preliminary advice, the NDC Detailed Advice Document. The SMC Committee, around 25 members with representation from all 14 NHS boards, then decides by majority vote at a monthly meeting held in public. Outcomes are accepted, accepted with restrictions, accepted on an interim basis, or not recommended. Advice is shared in confidence with boards and the company four weeks before publication.[1]
New Drugs Committee, then the SMC Committee. Usually 18 weeks; about 26 weeks with PACE or a complex PAS.[2]
Accepted, restricted, interim or not recommendedSimilar effectiveness, and the same or lower cost or limited net budget impact compared with accepted alternatives; decided by the SMC Executive.
Product Update if acceptedValidation in about eight weeks; available for up to three years while evidence is gathered.
Reassessment with the new evidenceWithin 3 months; usually up to 14 weeks.
Direct to the SMC CommitteeFull, abbreviated and fast-track submissions
The route depends on what the medicine is and how it compares on cost. SMC expects companies to contact the secretariat before any submission or resubmission.[3]
| Situation | Route |
|---|---|
| New active substance or new indication, even with a small population and low budget impact | Full submission on the NPAF |
| Same-class alternatives already accepted by SMC, similar clinical effectiveness, same or lower cost or limited net budget impact | Abbreviated submission (therapeutic class), after a Company Information Request Form |
| Resubmission within 3 months where the only change is a new or improved simple PAS or a confirmed list price reduction | Fast-track resubmission, direct to the SMC Committee, usually up to 14 weeks |
| Prevalence of 1 in 50,000 or less in Scotland, with the other ultra-orphan criteria met | Ultra-orphan pathway, using the UO NPAF |
Abbreviated submissions use the Abbreviated Submission Template and are decided by the SMC Executive, with a Product Update published if accepted. An indirect comparison can be used to show similar effectiveness within the class. Other resubmissions need new clinical evidence or a new analysis and follow the standard process. Where there is no new evidence, a company may request an Independent Review Panel up to 12 months after publication.
SMC submission timelines
The usual timeline is 18 weeks from scheduling to advice. About 26 weeks is needed for end-of-life and orphan medicines that go to PACE, for medicines with a complex PAS, and occasionally for complex submissions. NDC usually meets on the last Tuesday of the month and the SMC Committee on the first Tuesday, with a gap of usually 6 or 10 weeks between them.
Once dates are confirmed, a submission cannot be withdrawn except for regulatory reasons. After preliminary NDC advice the company comments on the document and has a 2-week window to submit a new or revised PAS. Submission deadlines are set in a monthly timetable on the SMC website, and SMC aims to issue advice as soon as possible after a medicine becomes available for prescribing.
Modifiers, PACE and the ultra-orphan pathway
Cost per QALY is only part of SMC's judgement. Modifiers can allow a higher ICER where the case is robust: a substantial improvement in life expectancy (normally a median gain of 3 months), a substantial improvement in quality of life, a targetable subgroup with extra benefit, no other proven therapeutic option, or bridging to definitive therapy. For orphan medicines (no more than 5 in 10,000) SMC accepts more uncertainty in the economic case.
For end-of-life medicines (a condition that usually leads to death within 3 years with current treatment) and orphan medicines, the company can request a Patient and Clinician Engagement (PACE) meeting if preliminary NDC advice is not recommended. Patient groups and clinicians describe benefits the conventional assessment may not capture, and the PACE statement is a major factor in the SMC decision. PACE adds one to three months.
Ultra-orphan medicines follow a separate pathway. SMC validates eligibility from a proforma within around eight weeks, carries out an initial assessment, and the medicine is available for up to three years while further evidence is gathered. A full updated submission is due within 3 months of the end of evidence generation, and SMC then decides on routine use.[4]
Evidence requirements, NICE differences and EU JCA
The SMC reference case asks for the comparator most likely to be displaced in NHSScotland, NHSScotland and social work costs, cost-utility analysis (cost-minimisation where equivalence is shown), EQ-5D as the preferred measure, and a 3.5% discount rate on costs and benefits, varied between 0% and 6% where results are sensitive. The patient perspective is the base case, with a patient and carer perspective as an additional analysis. Budget impact uses the SMC template.
- No scoping: SMC does not offer pre-submission scoping, so the company defines the decision problem itself.
- Different flexibilities: SMC keeps end-of-life and orphan definitions within PACE and modifiers, whereas NICE applies a severity modifier based on QALY shortfall.
- Interim acceptance: Available for medicines with a conditional marketing authorisation, a positive EAMS opinion or ILAP inclusion, with reassessment once data mature.
- PAS: Schemes are assessed by the Patient Access Scheme Assessment Group (PASAG), separate from SMC. SMC considers a PAS only once PASAG has accepted it.[5]
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 Scotland. JCA PICO work and indirect treatment comparisons can still be reused, narrowed to the NHSScotland comparator.
What we deliver
- Route advice and Company Information Request Forms
- Full NPAF submissions, including V4.0 transition planning
- Abbreviated and fast-track resubmissions
- Ultra-orphan proformas and UO NPAF submissions
- Cost-utility and cost-minimisation models, adapted to the SMC reference case (see model adaptation)
- Budget impact analyses on the SMC template
- Responses to NDC preliminary advice and secretariat queries
- PACE preparation and company statements
- PAS scenario analysis to support PASAG applications
What assessors look for
Most problems are avoidable. Submissions lose credibility when the comparator reflects a trial rather than NHSScotland practice, when a NICE model is submitted without Scottish costs or the patient-only base case, or when modifiers are claimed without robust survival or quality of life evidence. A PAS held back until after NDC can extend timelines. Company comments on the NDC document work best when they are short, focused on the main uncertainties, and correct factual errors precisely.
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 plan Scotland as part of a single UK evidence base, so the Scottish submission is consistent with the rest of your UK HTA submissions while meeting SMC's own requirements.
References
- Scottish Medicines Consortium. Interim acceptance decision option [Internet]. Glasgow: Scottish Medicines Consortium; [date unknown] [cited 2026 Oct]. Available from: https://scottishmedicines.org.uk/how-we-decide/interim-acceptance-decision-option/
- Scottish Medicines Consortium. PACE overview [Internet]. Glasgow: Scottish Medicines Consortium; [date unknown] [cited 2026 Oct]. Available from: https://scottishmedicines.org.uk/media/8998/pace-overview-v40.pdf
- Scottish Medicines Consortium. Making a submission (companies) [Internet]. Glasgow: Scottish Medicines Consortium; [date unknown] [cited 2026 Oct]. Available from: https://scottishmedicines.org.uk/making-a-submission/companies/
- Scottish Medicines Consortium. Ultra-orphan medicines for extremely rare conditions [Internet]. Glasgow: Scottish Medicines Consortium; [date unknown] [cited 2026 Oct]. Available from: https://scottishmedicines.org.uk/how-we-decide/ultra-orphan-medicines-for-extremely-rare-conditions/
- 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/
Sources reviewed October 2026. Methods and procedures change; check the latest agency guidance before submission.