Key points

• Six new medicines were recommended.

• Three medicines were directly placed in treatment guidelines.

• Four medicines were not recommended as standard treatment.

Recommended as standard treatment

• Durvalumab was recommended for resectable gastric cancer in combination with FLOT.

• Obinutuzumab was recommended for adults with lupus nephritis for up to one year.

• Bulevirtid was recommended for chronic hepatitis D with severe liver damage.

• Cilta-cel was extended to patients previously treated with other BCMA-targeted medicines.

• Glofitamab, olaparib, and sotatercept all received conditional recommendations.

Direct placements into treatment guidelines

• Depemokimab is included directly in the treatment guideline for biological medicines for severe asthma.

• Leuprorelin is included directly in the evidence review of medicines for medical castration in prostate cancer.

• Somapacitan is included directly in the evidence review of medicines for growth hormone deficiency.

Not recommended as standard treatment

• Natriumthiosulfat, givinostat, cabozantinib, and tafasitamab.

Process updates

• Two ongoing assessments were put on hold.

• Guidance for metastatic castration-sensitive prostate cancer and first-line unresectable NSCLC was updated after new tenders and prices.

Read more at https://medicinraadet.dk/nyheder/2026/overblik-medicinradets-beslutninger-i-juni-2026

Indlægget Six new medicines were recommended by the Danish Medicines Council in June blev først udgivet på NHTA.

The Danish Medicines Council has published its first national basis list with medicine recommendations for 15 common disease areas. The list replaces the five regional basis lists previously prepared by the regions.

What it includes

• First-choice medicine recommendations for adults across 15 disease areas.

• Cases where more than one medicine may be listed if products are assessed as equally efficacious and equally priced.

• A short print-friendly version and a full version with supporting text and source references.

Timing

• The list will next be updated in November 2026, including recommendations for type 2 diabetes.

• Regional basis lists on sundhed.dk will be updated soon to reflect the national recommendations.

Read more at https://medicinraadet.dk/nyheder/2026/ny-national-basisliste-til-praktiserende-laeger-fra-medicinradet

Indlægget The Danish Medicines Council launches national basis list for GPs blev først udgivet på NHTA.

Key points:

• Companies can now submit proposals up to and including the 6th week of the assessment process. Before, companies needed to submit these proposals from the beginning of the process.

• The change does not delay planned meetings with expert committees or the expected recommendation timeline.

• Alternative agreements can be used when there is uncertainty about a medicine’s effect or costs.

• The updated approach is part of the revised guidance on alternative agreements and follows cooperation with LIF.

Alternative agreements, including effect-based and economically based models, are already used in Denmark, and the DMC and Amgros encourages companies to utilise this opportunity when it is relevant.

Read more at https://medicinraadet.dk/nyheder/2026/medicinradet-og-amgros-giver-laegemiddelvirksomheder-mere-tid-til-at-foresla-alternative-prisaftaler

Indlægget The Danish Medicines Council and Amgros allow companies more time to propose alternative agreements blev først udgivet på NHTA.

The secretariat will move from four departments to three centres: Center for Chronic Diseases, Center for Cancer, and Center for Strategy and Staffing.

Why this change?:

• The change is a respond to more new tasks and a rising number of applications from pharmaceutical companies for assessment of new medicines.

• The new structure brings together staff with expertise in cancer, chronic disease, and cross-cutting tasks.

• Medicinrådet says the aim is to support its core work on medicine recommendations and guidance for general practice.

• The secretariat currently has about 90 employees.

Centre responsibilities:

• Center for Chronic Dieases covers chronic and rare diseases, ATMP medicines, treatment guidance for hospitals, and guidance for general practitioners.

• Center for Cancer covers cancer medicines, RWE initiatives, and methods development.

• Center for Strategy and Staffing covers communication, law, strategy, digitalisation, data, HR, finance, administration, and leadership support.

Read more at https://medicinraadet.dk/nyheder/2026/ny-organisering-af-medicinradets-sekretariat-fra-den-1-juni-2026

Indlægget The Danish Medicines Council reorganises its secretariat into three centres blev først udgivet på NHTA.

The treatment guidelines provide clinicians a quick overview of the council’s recommendations in a practice-oriented format, including:

• starting medication

• choice of product

• dose adjustment

• follow-up

• stopping treatment

Two guides are aimed at practicing child and adolescent psychiatrists and psychiatrists. A third guide is for general practitioners who may take over follow-up of adult patients who are stable on medication.

The guides are based on The Danish Medicines Council’s ADHD treatment evidence summary from December 2025 and are accompanied by a table with an overview of the relevant medicines and prices.

They are intended to support continuity of care across sectors.

Read more at https://medicinraadet.dk/nyheder/2026/nye-korte-vejledninger-til-psykiatere-og-praktiserende-laeger-om-adhd-medicin

Indlægget The Danish Medicines Council issues ADHD medication guidelines for the primary healthcare sector blev først udgivet på NHTA.

• Pertuzumab added to trastuzumab for adjuvant treatment of early HER2-positive breast cancer, based on new submitted data (reversing a 2018 decision); estimated impact: ~50 patients/year.

• Polihexanid for acanthamoeba keratitis (~35 patients/year); the council notes no documented better clinical effect than prior magistral products, but higher cost, and will revisit the recommendation after two years.

• Rucaparib for 1st line maintenance in advanced ovarian/fallopian tube/primary peritoneal cancer; effect described as comparable to niraparib (~100 patients/year), with a recommendation to use the cheaper option for at least 80% of patients.

• Toripalimab + cisplatin and gemcitabine for recurrent/metastatic nasopharyngeal carcinoma; estimated 10–15 eligible patients/year.

Other notes include two direct placements (donidalorsen; nusinersen 50/28 mg), multiple myeloma guideline updates, two non-recommendations (ravulizumab; vutrisiran), and a clock-stop for glofitamab.

Read more at https://medicinraadet.dk/nyheder/2026/overblik-medicinradets-beslutninger-i-april-2026

Indlægget Danish Medicines Council decisions from April 2026 blev først udgivet på NHTA.

Inspired by the NT-Council in Swden, The Danish Medicines Council has adopted a new, simplified process for PD-(L)1 inhibitors in locally advanced inoperable or metastatic cancer, meaning many patients can start treatment within 10 days after marketing authorisation.

Key facts from the announcement:

• The prior individual assessment (fast-track) process typically took around 14 weeks.

• Under the new model, new PD-(L)1 drugs and eligible indication extensions are combined into a common, general recommendation for the whole class (instead of case-by-case review).

• (Neo)adjuvant and perioperative indications are still assessed via Medicinrådet’s 14-week process.

• The simplified model applies when the PD-(L)1 inhibitor is used as monotherapy or with non-patent-protected medicines, and when one-year drug costs are in line with others in the class (accepted annual price threshold).

The model takes effect 1 June and will be evaluated after one year.

Having developed an extensive number of applications following the 14-week process, NHTA will follow this closely and it will be interesting to see the impact this change will generate (timelines, patient impact, budget impact, competition, etc.)

Read more at https://medicinraadet.dk/nyheder/2026/kraeftpatienter-far-hurtigere-adgang-til-ny-immunterapi

Indlægget Breaking: Denmark speeds up access to PD-(L)1 immunotherapies blev først udgivet på NHTA.

The council cited two main reasons:

• Uncertain added benefit: Available studies include few patients and only children up to age 7, leaving no data for older children, adolescents, or adults, and no long-term data on effect, safety, or disease course.
• Markedly higher price: The treatment is priced significantly above current standard care.

Current standard treatment in Denmark is prednisolone or deflazacort, which is associated with long-term adverse effects, including impacts on growth. The council noted it is uncertain whether vamorolone has the same effect on the disease; studies suggest the effect may be worse, and it is also uncertain whether it offers fewer side effects.

The council encouraged the company to return with more solid data on effect and adverse events and a significantly lower price for reassessment. Around 160 patients in Denmark live with Duchenne muscular dystrophy.

Read more at https://medicinraadet.dk/nyheder/2026/medicinradet-opfordrer-til-mere-data-og-lavere-pris-pa-laegemiddel-til-duchennes-muskeldystrofi

Indlægget Danish Medicines Council declines vamorolone for Duchenne blev først udgivet på NHTA.

Denmark’s medicines council has appointed Professor, PhD and GP Janus Laust Thomsen as a new member (20 March 2026). He was designated by the medical scientific societies (LVS) as the representative for the Danish society for general practice (DSAM).

Thomsen is head of the centre for general practice at Aalborg University and is a specialist in general medicine, with experience in research and quality improvement in the primary care sector.

In a statement, he said the council’s work is crucial so that both hospitals and general practice can base medicine choices on:

• the best available evidence
• responsible use of healthcare resources

He also emphasised the importance of close and trust-based collaboration across sectors to support rational and consistent decisions to benefit patients.

Thomsen replaces GP Maria Krüger, who has stepped down from the council.

Read more at https://medicinraadet.dk/nyheder/2026/professor-janus-laust-thomsen-er-nyt-medlem-af-medicinradet

Indlægget Janus Laust Thomsen joins Denmark’s medicines council blev først udgivet på NHTA.

The Danish Medicines Council has published its 2025 annual report, stating that it assessed whether 84 new medicines could be recommended as standard treatment in Denmark.

Key 2025 figures

• 84 new medicines assessed for potential standard treatment use.
• 53 of 84 (63%) were recommended or partly recommended.
• 86 applications received from pharmaceutical companies, up from 67 in 2024.

According to council chair Birgitte Klindt Poulsen, recommendations were supported by companies documenting patient benefit and offering prices aligned with the documented effect, or by collaborating on alternative agreements to enable treatment despite uncertainty.

The council also reported that the higher volume of applications contributed to it completing slightly fewer assessments on time in 2025 compared with previous years.

Read more at https://medicinraadet.dk/nyheder/2026/medicinradet-vurderede-rekordmange-laegemidler-i-2025

Indlægget Danish Medicines Council appraised 84 new medicines in 2025 blev først udgivet på NHTA.