Reference guide

HTA requirements compared across the UK, Europe and Canada.

Each market asks something different of an evidence package. This guide sets the main HTA systems side by side, so evidence planning starts from the differences that matter.

Reviewed by Hasan Bari, Founder and Managing Director · Updated October 2026

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Systems at a glance

Each row links to our detailed page for that market. Methods change: the figures below reflect each agency's guidance as reviewed in October 2026.^{[1, 2, 3]}

Country	HTA body	Perspective	Discount rate	How value is judged
England	NICE	NHS and personal social services	3.5%	£25,000 to £35,000 per QALY since April 2026, with a severity modifier^{[4, 5]}
Scotland	SMC	NHSScotland and social work	3.5%	Cost-effectiveness, with modifiers and PACE for end-of-life and orphan medicines
Wales	AWMSG	NHS Wales and personal social services	3.5%	Results reported at £20,000 and £30,000 per QALY in the 2025 submission guidance^{[6, 7]}
Ireland	NCPE (HIQA methods)	Publicly funded health and social care	4%	Cost-effectiveness is a statutory criterion under the Health (Pricing and Supply of Medical Goods) Act 2013
Germany	G-BA, IQWiG	Not applicable (added benefit)	Not applicable	Added benefit category and certainty set the basis for price negotiation
France	HAS (CT, CEESP)	Collective	2.5%	SMR and ASMR ratings; a CEESP efficiency opinion when the criteria are met^[8]
Netherlands	Zorginstituut	Societal	3% costs, 1.5% effects	Reference values of €20,000 to €80,000 per QALY by burden of disease
Belgium	INAMI-RIZIV (KCE methods)	Payer	3% costs, 1.5% outcomes	No explicit threshold
Sweden	TLV	Societal	3%	No fixed threshold; acceptable cost per QALY rises with severity
Norway	DMP, Nye Metoder	Extended health service	4%, then 3% and 2%	Benefit, resource use and severity (absolute shortfall)
Denmark	Medicinrådet	Limited societal	3.5%	Seven principles, with severity considered in special cases
Romania	ANMDMR	Not applicable (scorecard)	Not applicable	Points: 80 or more for unconditional inclusion, 60 to 79 for conditional inclusion
Canada	CDA-AMC	Publicly funded health care payer	1.5%	Probabilistic base case; price negotiated through pCPA

Discount rates compared

The discount rate alone can move an incremental cost-effectiveness ratio materially for treatments whose benefits arrive years after their costs, such as gene therapies and preventive interventions. Adapting a model across markets therefore starts with the reference case, before any input is changed. See model adaptation.

Swipe sideways to see the full chart.

Base-case annual discount rates in each agency's current methods guidance. * Norway: 4% for years 0 to 39, then 3% for years 40 to 74 and 2% thereafter. † France: declines gradually to a 1.5% floor beyond 30 years. Germany (AMNOG) and Romania (ANMDMR scorecard) do not require a cost-effectiveness reference case for the initial decision, so they are not shown.

Three ways systems judge value

European HTA systems fall into three broad groups, and each rewards a different kind of evidence.

Cost-effectiveness systems (the UK, Ireland, the Netherlands, Belgium, the Nordics, Canada) ask whether health gained justifies the cost. The model, its extrapolations and its uncertainty carry the decision.^{[9, 10, 11, 12]}
Added-benefit systems (Germany, France) rate clinical benefit against a comparator first, and that rating anchors the price. Comparator choice, endpoints and the certainty of the evidence carry the decision.
Scorecard systems (Romania) award points for decisions taken elsewhere and for cost against the comparator. Launch sequencing, timing and price against the comparator carry the decision.^[13]

In our view, the most efficient evidence plans design for all three at once: a comparative evidence base strong enough for an added-benefit rating, a model flexible enough for each reference case, and a launch sequence that builds the decisions a scorecard rewards.

Where the EU JCA fits

Regulation (EU) 2021/2282 has applied since 12 January 2025 to new oncology medicines and advanced therapy medicinal products. It extends to orphan medicines from 13 January 2028 and to all other medicinal products within the scope of Article 7(1) from 13 January 2030. The joint clinical assessment reports relative effectiveness and certainty for each PICO; it makes no value judgement. Member States give the report due consideration and do not request evidence already submitted at EU level, while pricing and reimbursement remain national decisions.

Each country page describes how that national body uses the report. See EU JCA dossiers and joint scientific consultation.^[14]

What this means for evidence planning

Set the comparator strategy against the widest plausible set of national standards of care, not the trial comparator alone.
Build one global model with switchable reference cases for perspective, discount rate and costing.
Plan indirect comparisons for the PICOs you expect, before pivotal data read out.
Sequence launches with reference pricing and scorecard rules in view. See international reference pricing.

Why Evidaxia

Our EU-level work, including EU JCA dossiers, PICO scoping and indirect comparisons, is built to feed national processes across Europe, and our founder worked on the assessor's side at NICE as an HTA Technical Lead and Analyst. We help teams plan one evidence base that works in every market they launch in.^[15]

References

Scottish Medicines Consortium. Guidance to submitting companies for completion of the NPAF [Internet]. Glasgow: Scottish Medicines Consortium; [date unknown] [cited 2026 Oct]. Available from: https://scottishmedicines.org.uk/media/10768/20261021-guidance-to-submitting-companies-for-completion-of-npaf.pdf
Tandvårds- och läkemedelsförmånsverket (TLV). Tandvårds- och läkemedelsförmånsverkets allmänna råd om ekonomiska utvärderingar (TLVAR 2017:1) [Internet]. Stockholm: TLV; 2017 [cited 2026 Oct]. Available from: https://www.tlv.se/download/18.467926b615d084471ac3230c/1510316374332/TLVAR_2017_1.pdf
Medicinrådet. Health economic analysis and extrapolation guideline [Internet]. Copenhagen: Medicinrådet; [date unknown] [cited 2026 Oct]. Available from: https://filer.medicinraadet.dk/media/wpqfs3g2/health-economic-analysis-and-extrapolation-guideline-vers-1-1.pdf
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 [cited 2026 Oct]. Available from: https://www.nice.org.uk/news/articles/changes-to-nice-s-cost-effectiveness-thresholds-confirmed
National Institute for Health and Care Excellence. Changes to NICE's cost-effectiveness thresholds [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
All Wales Therapeutics and Toxicology Centre. HTA submission form guidance notes [Internet]. Cardiff: All Wales Therapeutics and Toxicology Centre; 2025 Jun [cited 2026 Oct]. Available from: https://awttc.nhs.wales/accessing-medicines/pharmaceutical-industry/industry-submission-forms-new-process/hta-submission-form-guidance-notes-final-june-2025/
Direktoratet for medisinske produkter (DMP). Submission guideline [Internet]. Oslo: Direktoratet for medisinske produkter (DMP); 2026 Jul [cited 2026 Oct]. Available from: https://www.dmp.no/globalassets/documents/offentlig-finansiering-og-pris/dokumentasjon-til-metodevurdering/submission-guideline-july-2026.pdf
Haute Autorité de Santé. Choices in methods for economic evaluation [Internet]. Saint-Denis: Haute Autorité de Santé; 2020 [cited 2026 Oct]. Available from: https://www.has-sante.fr/upload/docs/application/pdf/2020-11/methodological_guidance_2020_-choices_in_methods_for_economic_evaluation.pdf
Health Information and Quality Authority. National guidelines for the economic evaluation of health technologies in Ireland [Internet]. Dublin: Health Information and Quality Authority; 2025 [cited 2026 Oct]. Available from: https://www.hiqa.ie/sites/default/files/2025-03/Economic-Evaluation-Guidelines.pdf
Zorginstituut Nederland. Guideline for economic evaluations in healthcare [Internet]. Diemen: Zorginstituut Nederland; 2024 [cited 2026 Oct]. Available from: https://english.zorginstituutnederland.nl/documents/2024/01/16/guideline-for-economic-evaluations-in-healthcare
Belgian Health Care Knowledge Centre (KCE). Belgian guidelines for economic evaluations and budget impact analyses. KCE Report 400 [Internet]. Brussels: KCE; 2025 [cited 2026 Oct]. Available from: https://kce.fgov.be/sites/default/files/2025-05/KCE400_Method_guidelines_economic_evaluations.pdf
Canada's Drug Agency (CDA-AMC). Guidelines for the economic evaluation of health technologies, 4th edition [Internet]. Ottawa: Canada's Drug Agency (CDA-AMC); [date unknown] [cited 2026 Oct]. Available from: https://www.cda-amc.ca/guidelines-economic-evaluation-health-technologies-canada-4th-edition
Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România (ANMDMR). Order 861/2014, consolidated Romanian text including Order 1142/2025 [Internet]. Bucharest: Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România (ANMDMR); [date unknown] [cited 2026 Oct]. Available from: https://www.anm.ro/_/ORDINE/Ordin%20861-2014.pdf
Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU. Official Journal of the European Union. 2021 Dec 22;L458:1-32. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32021R2282
National Institute for Health and Care Excellence. NICE health technology evaluations: the manual (PMG36) [Internet]. London: NICE; 2022 Jan 31 [updated 2026 Oct 13; cited 2026 Oct]. Available from: https://www.nice.org.uk/process/pmg36

Sources reviewed October 2026. Methods and procedures change; check the latest agency guidance before submission.

Evidaxia Briefing

One evidence package, thirteen answers.

Our 21-page guide compares thirteen HTA systems across the UK, Europe and Canada, with 16 exhibits and full references. Subscribe to Evidaxia Briefing, our sourced analysis of market access, HTA decisions, evidence and health policy, and the guide downloads the moment you subscribe.

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FAQ

Common questions

Anything else? Email info@evidaxia.com.

What discount rate does each HTA agency use?

NICE, SMC, AWMSG and Medicinrådet use 3.5%; Ireland 4%; Norway 4% for the first 40 years, then 3% and 2%; Sweden 3%; France 2.5%; the Netherlands and Belgium 3% for costs and 1.5% for outcomes; and CDA-AMC in Canada 1.5%.

Which countries do not use a cost-effectiveness threshold?

Germany judges added benefit rather than cost-effectiveness, and Romania uses a points-based scorecard. Scotland, France, Belgium, Sweden, Denmark and Canada consider cost-effectiveness without a fixed published threshold.

What is the NICE cost-effectiveness threshold in 2026?

NICE has used a range of £25,000 to £35,000 per QALY gained since April 2026, with a severity modifier for the most severe conditions.

Does the EU JCA replace national HTA?

No. The joint clinical assessment covers relative clinical effectiveness only. Each country still decides value, price and reimbursement nationally, giving the JCA report due consideration.

Can one health economic model serve every market?

One well-built global model can, if its reference case (perspective, discount rate, costs and comparators) can be switched for each market and validated locally.

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