How the Danish system works
Hospital medicines: The Danish Medicines Council recommends which new medicines and indications become possible standard treatment in Danish hospitals. It weighs the clinical value of a medicine against the cost of treatment, and the Council alone decides on the recommendation. Amgros, the procurement organisation owned by the five regions, negotiates the price with the company on the basis of the Council's assessment report.
Outpatient medicines: Reimbursement of medicines sold in pharmacies is a separate route. The company applies to the Danish Medicines Agency (Lægemiddelstyrelsen) for general or general conditional reimbursement under sections 144 and 152 of the Health Act. A trial scheme running from 1 July 2025 to June 2028 lets companies negotiate confidential prices for selected reimbursed medicines with Amgros. For applications received from 1 October 2026, the Medicines Council carries out the health economic assessment of the confidential price, Amgros negotiates, and the Danish Medicines Agency decides on reimbursement.
- From EMA Day 120Request for assessmentThrough the Applicant Portal
- After CHMP opinionApplicationHealth economic and budget impact analyses in one Excel file linked to the Council's standard sheets
- 10 working daysValidationThe secretariat checks formal requirements
- AssessmentCouncil assessmentClock stops are possible where there are substantive gaps
- Draft reportCompany fact-check10 business days; an optional two-page note with no new data
- In parallelAmgros price negotiationUp to about 14 days, starting with the draft report; alternative agreements are proposed by week 6[1]
- 18 weeksCouncil recommendationGenerally published the next day
Four assessment processes
Since 1 April 2024, the Medicines Council has matched the timeline to the complexity of the assessment:
| Process | Used for | Health economics |
|---|---|---|
| 18 weeks | New medicines that fit no other track, and reassessments on new data | Cost-utility or cost analysis, plus budget impact |
| 16 weeks | Direct placement in an existing treatment guideline, and reassessment on a new price | None |
| 14 weeks | Some PD-(L)1 inhibitor extensions (adjuvant, neoadjuvant, perioperative) and extensions from adults to children | None |
| 2 weeks | PD-(L)1 inhibitors in locally advanced inoperable or metastatic cancer, under the general immunotherapy recommendation | None |
From request to recommendation
- Request for assessment: no earlier than Day 120 of the EMA procedure (Day 1 for extensions of indication and accelerated assessments). Since 5 October 2026, requests go through the Council's Applicant Portal. The company can ask for a dialogue meeting in the request form; the Secretariat's views are not binding.
- Application: possible once the CHMP has given a positive opinion, or for a JCA medicine once the HTA Coordination Group has approved the JCA report. It contains the application form, the EPAR and one Excel file holding both the health economic analysis and the budget impact analysis, linked to the Council's standard sheets. A blinded version and a version marking confidential information are required.[2]
- Technical validation: the Secretariat checks formal requirements within 10 working days. Substantive gaps can lead to a clock stop.
- Draft report: sent to the company and Amgros. The company has 10 business days to check facts and may add a two-page note with no new data.
- Decision: the Council decides at its meeting and generally publishes the recommendation the next day.
Evidence and methods requirements
The Council's methodological guideline (version 2.0, March 2026) and its supporting guidance documents set the requirements:
- Analysis: a cost-utility analysis reported as an ICER. A cost-minimisation analysis is acceptable only where the new medicine is equivalent on all relevant endpoints, including quality of life and safety.
- Perspective: limited societal. It includes QALYs, medicine and hospital costs, and patient time and transport. Municipal or caregiver costs may be considered; productivity losses are excluded.[3]
- Time horizon: long enough that extending it would not change results materially, and adjustable in the model.
- Discounting: one fixed rate for costs and effects, matching the Ministry of Finance's 0 to 35 year rate (3.5% as of 2025), applied from week 53. The Council does not use a declining rate.
- Quality of life: EQ-5D-5L with Danish preference weights. Mapping or external sources only where trial data are missing or very limited.
- Costs: Danish practice and unit costs, DRG tariffs and pharmacy purchase prices (AIP).
- Budget impact: a five-year horizon.
The Council works within the Danish Parliament's seven principles for prioritising hospital medicines, and applies the principles of caution and severity only in special cases. See health economic modelling.
Amgros price negotiation and alternative agreements
Negotiation with Amgros can start once the draft assessment report reaches the company, and typically lasts no more than 14 days. Amgros bases it on the assessment report and on current and future market conditions. Its negotiation note, with the result, goes to the Council and is published after the decision.
Where effect or cost is uncertain, an alternative agreement can make a recommendation possible. Amgros defines these as any agreement other than a flat discount. They can be outcome-based, where payment falls away if the patient does not benefit, or financial, such as prices that fall as use rises. Since June 2026, companies can propose an alternative agreement up to week 6 of the assessment. Where several medicines have similar clinical effect, Amgros runs tenders based on the Council's treatment guidelines.
How the EU JCA interacts with Medicinrådet
The EU-wide phase-in dates are set out in our HTA requirements comparison. The Regulation requires national HTA bodies to give due consideration to the JCA report and not to request evidence already submitted at EU level.
- The Council uses the JCA report as the basis for its clinical assessment, and the applicant states which parts of the application the report covers.
- The JCA report is due no later than 30 days after the European Commission grants marketing authorisation, and the application can follow its publication.
- The Council still assesses transferability to Danish practice, value for Danish patients, economic consequences, severity and the organisation of treatment.
See EU JCA dossiers and our Nordic HTA overview.
What we deliver and what assessors look for
- Requests for assessment and Medicinrådet applications, including the blinded and marked versions
- Cost-utility and budget impact analyses in one Excel file, linked to the Council's standard sheets
- Utility analyses with Danish EQ-5D-5L weights, and mapping where needed
- Indirect treatment comparisons and evidence for the Danish PICO
- Analysis for Amgros price talks and alternative agreement proposals
- Applications for general reimbursement with the Danish Medicines Agency
What makes an application run smoothly is predictable: a comparator that reflects Danish standard treatment, a model that passes technical validation and meets the security requirements for Excel files, utilities from the Danish value set, and confidential data clearly marked before publication.
Why Evidaxia
Our EU-level work, covering EU JCA dossiers, PICO scoping, indirect comparisons and network meta-analyses, and global model adaptation, is built to feed national processes such as the Medicines Council's, and we bring that experience to Danish applications. Our founder worked on the assessor's side at NICE as an HTA Technical Lead and Analyst, so we prepare models that are transparent and easy to check.
References
- Amgros. New medicines and negotiation [Internet]. Copenhagen: Amgros; [date unknown] [cited 2026 Oct]. Available from: https://amgros.dk/laegemidler/prisforhandling-og-udbud/nye-laegemidler-og-forhandling/
- Medicinrådet. Joint European assessments [Internet]. Copenhagen: Medicinrådet; [date unknown] [cited 2026 Oct]. Available from: https://medicinraadet.dk/om-os/det-laver-vi/faelles-europaeiske-vurderinger
- 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
- Medicinrådet. Process guide for assessing new medicines (v3.0) [Internet]. Copenhagen: Medicinrådet; [date unknown] [cited 2026 Oct]. Available from: https://filer.medicinraadet.dk/media/2ohp4u20/the-danish-medicines-councils-process-guide-for-assessing-new-medicines-vers-3-0.pdf
Sources reviewed October 2026. Methods and procedures change; check the latest agency guidance before submission.