How the Nordic systems work
Each Nordic country separates outpatient reimbursement from the introduction of hospital medicines, and the two routes often sit with different bodies.
Sweden: The Dental and Pharmaceutical Benefits Agency (TLV) decides on pricing and reimbursement for outpatient medicines; decisions on new original products are made by its Pharmaceutical Benefits Board. For hospital medicines, TLV produces health economic assessments on request from the NT Council (Rådet för nya terapier), an expert group within the Swedish Association of Local Authorities and Regions. The NT Council then makes a recommendation to the regions. TLV makes no reimbursement decision in that route.[1]
Norway: Nye Metoder is the national priority-setting system for specialist (hospital) care, owned by the four regional health authorities. Bestillerforum commissions an assessment, usually from the Norwegian Medical Products Agency (DMP, formerly the Norwegian Medicines Agency, renamed on 1 January 2024). Sykehusinnkjøp HF handles price discussions with the supplier, and Beslutningsforum, made up of the four regional chief executives, makes the final decision. DMP also assesses medicines for outpatient reimbursement on the blue prescription scheme.
Denmark: The Danish Medicines Council (Medicinrådet), established by Danish Regions in 2017, recommends which new hospital medicines become possible standard treatment. Amgros, the regions' procurement organisation, agrees the price with the company on the basis of the assessment report.[2]
Finland: The Pharmaceuticals Pricing Board (HILA) decides reimbursement status and reasonable wholesale prices for outpatient medicines under the Health Insurance Act. For hospital medicines, the Finnish Medicines Agency (Fimea) assesses therapeutic and economic value, and the Council for Choices in Health Care in Finland (COHERE, Palveluvalikoimaneuvosto) uses Fimea's report as its main source for recommendations.[3]
The four countries at a glance
| Sweden | Norway | Denmark | Finland | |
|---|---|---|---|---|
| Outpatient reimbursement | TLV (Pharmaceutical Benefits Board) | DMP (blue prescription) | Danish Medicines Agency (Lægemiddelstyrelsen); Medicinrådet covers hospital-only medicines | HILA |
| Hospital medicines | TLV assessment for the NT Council, recommendation to regions | DMP assessment, decision by Beslutningsforum (Nye Metoder) | Medicinrådet assessment and recommendation | Fimea assessment, COHERE recommendation |
| Price | TLV decision; side agreements between regions and company | Sykehusinnkjøp HF | Amgros | HILA (outpatient) |
| Economic method | Cost per QALY, societal perspective, 3% discount rate | Cost per QALY, extended health-service perspective, 4% (years 0 to 39) | Cost-utility or cost analysis, with budget impact | Health economic evaluation in the HILA application |
| Severity | Accepted cost per QALY weighed against severity | Absolute shortfall in QALYs | Severity principle in special cases | Severity among COHERE's criteria |
Evidence and methods requirements
Sweden: TLV's general guidance asks for costs and health effects discounted at 3%, with sensitivity analyses at 0% and 5%. TLV applies a societal perspective and judges whether the cost per QALY is reasonable in relation to the severity of the condition, alongside the human dignity and needs-solidarity principles. Severity is graded, and higher grades support a higher accepted cost per QALY. Three-party talks between TLV, the regions and the company can lead to a side agreement in which the company refunds part of the cost to the regions.
Norway: The three priority criteria are benefit, resource use and severity, weighed together. Severity is the absolute shortfall: the QALYs a patient group loses compared with people of the same age, under current standard treatment. DMP's submission guideline, updated from 6 July 2026, separates must and should requirements, and the Norwegian EQ-5D-5L value set has been mandatory for adults in new submissions since 1 September 2025.[4]
Denmark: Medicinrådet has used QALYs since 2021. In the standard 18-week process, the application includes a cost-utility or cost analysis and a budget impact analysis, both uploaded in Excel. The Council applies the Danish Parliament's seven principles for prioritising hospital medicines, with caution and severity considered only in special cases.
Finland: A HILA application for a new medicine includes information on therapeutic value, costs and economic value, a health economic evaluation, a market forecast and prices in other EEA states.
See health economic modelling and model adaptation.
Joint Nordic assessment (JNHB)
Joint Nordic HTA-Bodies (JNHB), previously FINOSE, brings together TLV, DMP, Medicinrådet, Fimea and Landspitali University Hospital in Iceland. The company signs a waiver of confidentiality and submits one joint dossier and health economic model to TLV, which distributes it to the assessment team. The joint report covers relative effectiveness and health economics. Pricing, reimbursement and recommendations remain national decisions.[5]
How the EU JCA interacts with Nordic HTA
The EU-wide phase-in dates are set out in our HTA requirements comparison. Member states must give due consideration to the JCA report, while pricing and reimbursement remain national. Norway applies the regulation through the EEA Agreement, and Nye Metoder received its first JCA medicines in 2026.[6]
- Sweden: an application to TLV is not complete until the JCA report is published, and the clock starts only then.
- Denmark: the applicant states which parts of the application the JCA report covers and refers to it.
- Finland: HILA asks for a reasoned opinion on whether the JCA, and its PICO, still fit at the time of application. HILA answers PICO surveys for outpatient medicines and Fimea for hospital medicines.
See EU JCA dossiers.
What we deliver
- Nordic launch planning: route, sequence and whether a JNHB assessment fits
- TLV submissions for outpatient reimbursement and evidence for health economic assessments of hospital medicines
- DMP documentation packages for Nye Metoder and blue prescription reimbursement
- Medicinrådet applications, including cost-utility and budget impact models in Excel
- HILA reimbursement applications and evidence for Fimea assessments
- Cost-utility models adapted to each country's perspective, discount rate, value set and severity method
- Systematic reviews and indirect treatment comparisons that serve the JCA and Nordic submissions
- Analysis to support side agreements and commercial agreements
What assessors look for
- Comparators from local practice: A global comparator rarely matches Nordic standard treatment in every country.
- Complete documentation: In Norway, unmet must requirements mean the package is treated as not received and assessment does not start.
- Severity calculated correctly: Absolute shortfall in Norway depends on current population norm data and the right baseline.
- The right value set: A model built on another country's utilities needs rework before it is ready.
- A consistent JCA story: National analyses that depart from the JCA PICO need clear reasons.
Why Evidaxia
Our EU-level work, including EU JCA dossiers, PICO scoping, indirect comparisons and network meta-analyses, and global model adaptation, is built to feed Nordic national processes, and we bring that EU experience to TLV, DMP, Medicinrådet and Fimea submissions. We have also worked from the assessor's side at NICE and supported SMC, AWMSG and NCPE submissions and worked on CDA-AMC projects. We work alongside your local market access teams.
References
- Tandvårds- och läkemedelsförmånsverket (TLV). Health economics [Internet]. Stockholm: Tandvårds- och läkemedelsförmånsverket (TLV); [date unknown] [cited 2026 Oct]. Available from: https://www.tlv.se/in-english/medicines/health-economics.html
- Medicinrådet. About the Danish Medicines Council [Internet]. Copenhagen: Medicinrådet; [date unknown] [cited 2026 Oct]. Available from: https://medicinraadet.dk/om-os/in-english
- COHERE Finland. Handling process of recommendations [Internet]. Helsinki: COHERE Finland; [date unknown] [cited 2026 Oct]. Available from: https://palveluvalikoima.fi/en/handling-process-of-recommendations
- Direktoratet for medisinske produkter (DMP). Priority criteria (resource use, benefit, severity) [Internet]. Oslo: Direktoratet for medisinske produkter (DMP); [date unknown] [cited 2026 Oct]. Available from: https://www.dmp.no/offentlig-finansiering/offentlig-finansiering-av-legemidler-og-medisinsk-utstyr/hva-inneberer-prioriteringskriteriene-ressursbruk-nytte-og-alvorlighet
- Joint Nordic HTA-Bodies (JNHB). About [Internet]. [place unknown]: Joint Nordic HTA-Bodies (JNHB); [date unknown] [cited 2026 Oct]. Available from: https://jnhtabodies.org/about
- 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
Sources reviewed October 2026. Methods and procedures change; check the latest agency guidance before submission.