What is included

• The guideline and template were updated as of July 2026.

• DMP clarified its requirements for “must” and “should” criteria.

• The submission template was updated to match the guideline.

Read more at https://www.dmp.no/en/public-funding-and-pricing/health-technology-assessments/medicines/submission-of-documentation-for-single-technology-assessment-of-pharmaceuticals

Indlægget DMP updates STA submission guidance blev først udgivet på NHTA.

• AI to transform healthcare in the EU: Using AI to address complex global challenges and revolutionise healthcare is quickly becoming a reality. The EU is shaping a robust framework to foster responsible development and deployment and to overcome some of the practical barriers to support the use of AI to enhance equity, improve care and ensure that new technologies, treatments, and medicines benefit society at large. Read more at https://health.ec.europa.eu/ehealth-digital-health-and-care/artificial-intelligence-healthcare_en.

• Digital health and care in EU: Digital health (eHealth) is a vital tool to improve healthcare efficiency, quality, and accessibility across the EU, but is currently limited due to the fragmented nature of the data used across different healthcare systems. To optimise collaboration between member states, the EU has established the European Health Data Space (EHDS), a health-specific governance framework designed for sharing health data across borders establishing clear rules, common standards, and practices along with digital infrastructures aiming to improving healthcare. Read more at https://health.ec.europa.eu/ehealth-digital-health-and-care/digital-health-and-care_en.

Indlægget Updates on the use of AI in healthcare and digital health and care in the EU blev først udgivet på NHTA.

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.

NICE has published final draft guidance recommending cemiplimab (Libtayo, Regeneron) for adults whose cancer has worsened during or after platinum-based chemotherapy, and who have not previously had immunotherapy.

Key points

• Around 90 adults a year are expected to be eligible.

• NICE said the treatment can prolong the time before disease progression and improve overall survival versus standard chemotherapy.

• Trial data from EMPOWER Cervical-1 showed average survival of 11.7 months with cemiplimab, compared with 8.5 months with single-agent chemotherapy.

• At 24 months, more than twice as many patients treated with cemiplimab were still alive.

• The treatment will be available immediately via the Cancer Drugs Fund before moving to routine NHS commissioning 90 days after final guidance is published.

Read more at https://www.nice.org.uk/news/articles/new-treatment-option-recommended-for-recurrent-or-metastatic-cervical-cancer

Indlægget NICE recommends cemiplimab for recurrent or metastatic cervical cancer blev først udgivet på NHTA.

Positive recommendations:

• Blinatumomab for newly diagnosed Philadelphia chromosome-negative, CD19-positive B-cell acute lymphoblastic leukemia in adults.

• Retifanlimab as first-line monotherapy for eligible adults with metastatic or recurrent locally advanced Merkel cell carcinoma.

• Trastuzumab deruxtecan for HER2-positive breast cancer after at least one anti-HER2-based treatment.

• Trastuzumab deruxtecan for unresectable or metastatic HER2-low breast cancer after prior chemotherapy.

Conditional recommendations:

• Klesrovimab conditionally for a limited target group during the 2026–2027 RSV season.

Negative recommendations:

• Trastuzumab deruxtecan is not included for unresectable or metastatic hormone receptor-positive HER2-low or HER2-ultralow breast cancer after endocrine therapy, where endocrine therapy is not considered suitable as next-line treatment.

All recommendations require the marketing authorisation holder and purchaser to agree a price significantly below the public wholesale price. Read more at https://palveluvalikoima.fi/-/palko-antoi-16.6.2026-kokouksessaan-kuusi-laakesuositusta

Indlægget Palko has issued six new drug recommendations blev først udgivet på NHTA.

Key findings

• More than 200 new active substances have been introduced in Finland over the past decade.

• Of 330 medicines approved in Europe from 2015 to 2024, 204 were in use in Finland by the end of 2025.

• Outpatient medicines are usually adopted in under 1.5 years after marketing authorisation, and hospital medicines in under one year.

• Almost all outpatient medicines with at least moderate added therapeutic value are reimbursed if the company applies for reimbursement.

• Nearly half of the new medicines were assessed as offering no therapeutic added value, while only one was assessed as offering major added value.

The report is based on public assessments from HAS and on a joint publication from Kela and Fimea.

Read more at https://fimea.fi/-/suomessa-on-otettu-uudet-avohoidon-laakkeet-kayttoon-lahes-poikkeuksetta-jos-niista-on-lisahyotya-aiempiin-hoitoihin-verrattuna

Indlægget Finland adopts most medicines with added value blev først udgivet på NHTA.

TLV has announced new general guidelines and regulations for pricing and reimbursement of medicines.

What changes

• The guidelines consolidate assessment criteria for what constitutes a reasonable cost

• Add criteria for price increases

• Introduce a simplified application process for certain new drugs or formulations.

• A revised handbook will be published on TLV’s website in late June 2026

Timeline

• The new guidelines and regulations take effect from 1 October 2026.

• On the same date, the current rules and general advice will cease to apply.

• TLV will host a webinar on 2 September 2026 on practical application and the updated handbook.

Read more at https://www.tlv.se/press/nyheter/arkiv/2026-06-16-nya-allmanna-riktlinjer-och-foreskrifter-om-subvention-och-prissattning-av-lakemedel.html

Indlægget TLV publishes new pricing and reimbursement guidelines 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.

The European Commission has published the first **joint clinical assessment (JCA)** report, marking a key milestone in the EU HTA framework.

**What was assessed**
– The report covers **Ojemda (tovorafenib)**, an orphan medicine for **paediatric low-grade glioma**.
– It assesses the medicine’s **relative effectiveness** and **relative safety**.
– The report was endorsed by all Member States.

**What the Commission says**
– JCAs let Member States work together on clinical assessments.
– The framework is intended to reduce duplication and save time and resources.
– The Commission says the reports can support national pricing and reimbursement decisions.
– Since January 2025, **18 JCAs** have been initiated for new cancer medicines and advanced therapy medicinal products.

Further joint clinical assessment reports are expected in the coming months. Read more at https://health.ec.europa.eu/document/download/b853b3f5-39d1-4aa3-8787-b1125d0d06d1_en?filename=hta_20260609_news-first-jca-report_en.pdf

Indlægget First JCA report published for Ojemda blev først udgivet på NHTA.

NICE has recommended mirvetuximab soravtansine (Elahere, AbbVie) for adults with folate receptor-alpha-positive platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer after 1 to 3 previous treatments.

Key points:

• It is the first new NHS treatment for this patient group in over 20 years.

• In the MIRASOL study, overall survival was 16.9 months versus 13 months with chemotherapy.

• Time before disease worsened was 5.6 months versus 4 months with chemotherapy.

• The treatment is available now through the Cancer Drugs Fund and will later move to routine commissioning.

NICE said the treatment represents good use of NHS resources, taking into account the severity of the condition.

Read more at https://www.nice.org.uk/news/articles/nice-recommends-new-treatment-for-resistant-ovarian-cancer

Indlægget NICE recommends first new NHS treatment in over 20 years for women with resistant ovarian cancer blev først udgivet på NHTA.