A recent article on Lif’s news site highlights that, according to the 2025 WAIT report, only 22% of new non-oncology orphan medicines authorised by EMA were available to Swedish patients in 2025.

The article points to three areas that could improve access:

• Broader consideration of societal value in pricing and reimbursement assessments
• Faster and more predictable processes for introducing new treatments
• Better coordination between authorities, regions, healthcare providers and patients

It also highlights the importance of including patient and caregiver perspectives early in the process.

What does Sweden need to do differently to improve access to treatments for rare diseases?

Read the article on Lif: Fler med sällsynta diagnoser kan få behandling – vad vill Sverige?

#RareDiseases #PatientAccess #Healthcare #LifeScience

Indlægget Lif urges faster, broader access decisions for rare-disease treatments blev først udgivet på NHTA.

As part of the work, NHTA will contribute to the development of digital solutions that support ATMP Denmark’s role as a national single point of entry. Among other things, the collaboration will contribute to a knowledge bank and a map making it easier to locate relevant information, stakeholders, expertise, and collaborative opportunities within the ATMP field.  

“ATMP Denmark has a strong vision of unifying and strengthening the Danish ATMP landscape. We are proud to support that vision with our expertise in digitalization, health data, and knowledge dissemination, making it easier to find, share, and utilize knowledge and networks across sectors ” says Andreas Pagh, Partner at NHTA.  

The knowledge bank will gather relevant materials, guidelines and resources on advanced therapies in one place, while the landscape map will provide a more visual and structured overview of the Danish ATMP landscape. 

For ATMP Denmark, this collaboration is part of a broader ambition to make the field more accessible and to support the development and adoption of advanced therapies in Denmark. 

“If Denmark is to maintain a strong position in the ATMP field, we need a shared overview and better access to knowledge across sectors. With the knowledge bank and the map, we are taking concrete steps toward making ATMP Denmark a useful gateway for researchers, clinicians, companies, and other stakeholders working on the development and implementation of advanced therapies,” says Malene Kristine Nielsen, Program Manager at ATMP Denmark. 

The initial solutions are being developed and refined on an ongoing basis in collaboration with relevant professional communities. The goal is for these tools to be expanded over time and to help make knowledge, experience, and networks within the ATMP field easier to find and utilize. 

About ATMP Denmark  

ATMP Denmark works for the development and implementation of advanced therapies in Denmark. ATMP Denmark will contribute to more knowledge, a better overview and stronger collaboration across actors in the Danish ATMP landscape.  

About NHTA  

NHTA contributes with competencies in data, analyses, digitalization, communication and healthcare communication. In collaboration with ATMP Denmark, NHTA will support the development of solutions that make knowledge and overview in the ATMP area more accessible. 

Indlægget ATMP Denmark and NHTA have entered into a collaboration to develop specific digital tools that will make it easier for stakeholders in Denmark to find information, create an overview, and collaborate on advanced therapies. blev først udgivet på NHTA.

The CEOs of the regional health authorities have decided that the recommendations will apply as instructions in their health trusts. The tender, administered by Sykehusinnkjøp HF, is valued at around three billion NOK and runs until 30 September 2027.

Selected changes:

• Tevimbra becomes first choice in several lung cancer settings and ranks ahead of Loqtorzi in nasopharyngeal cancer.

• In extensive-stage small-cell lung cancer, Tevimbra plus chemotherapy replaces the two Tecentriq formulations, which are no longer listed for this treatment.

• Tecentriq retains first choice in selected NSCLC settings and first-line triple-negative breast cancer with chemotherapy.

• Opdivo moves from first to second place around surgery for high-risk non-small-cell lung cancer.

• Keytruda remains behind Tecentriq and Libtayo in first-line metastatic non-small-cell lung cancer with high PD-L1 expression.

• Calquence plus Venclyxto ranks ahead of Imbruvica plus Venclyxto in previously untreated chronic lymphocytic leukaemia.

Read more at https://www.healthtalk.no/kreft/dette-er-vinnerne-og-taperne-i-kreftanbudet/214714

Indlægget These are the winners and losers in Norway’s cancer drug tender blev først udgivet på NHTA.

The recommendations included medicines for haemophilia A, ALK-positive advanced non-small cell lung cancer, generalised myasthenia gravis, platinum-resistant ovarian cancer, hidradenitis suppurativa, short bowel syndrome and rabies prophylaxis.

Key decisions

• Povofortay was recommended for active moderate to severe hidradenitis suppurativa in adults; EMA describes it as the first daily oral treatment for patients refractory or intolerant to anti-TNF therapy.

• Pebrilzo, for breast cancer in adults, was the first biosimilar recommended following the tailored clinical approach.

• Two generics, Inijaq and Ruxolitinib Zentiva, also received positive opinions.

• CHMP recommended 11 indication extensions, including a lower age of use for Anzupgo to adolescents aged 12 years and older.

Two initial marketing-authorisation applications and three extension applications were withdrawn. Applicants requested re-examination of July negative opinions for Kemsu, Meplyffa and Qezzaqar. CHMP confirmed its refusal of Xervyteg after re-examination.

Read more at https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-september-2026

Indlægget CHMP recommends 12 medicines at September meeting blev først udgivet på NHTA.

Around 1,000 people with HER2-low advanced or metastatic breast cancer can now be offered Enhertu (trastuzumab deruxtecan), made by Daiichi Sankyo and AstraZeneca, after their disease has progressed following treatment.

NICE said clinical trial evidence showed that Enhertu can help people live longer and increase the time before their cancer gets worse, compared with standard chemotherapy.

Previously, NICE’s independent committee had been unable to support the treatment at the companies’ proposed price. Enhertu was the only breast cancer drug that NICE had not recommended since 2018; 25 other breast cancer treatments received positive NICE recommendations over that period.

A commercial solution was agreed following changes to NICE methods under the UK/US Pharmaceutical Pricing Agreement. These included higher cost-effectiveness thresholds from April and a new quality-of-life assessment method published on 27 August 2026.

The final draft guidance is open to appeal until 5pm on 7 October 2026.

Read more at https://www.nice.org.uk/news/articles/nice-recommends-enhertu-for-people-with-her2-low-advanced-breast-cancer

Indlægget Enhertu becomes available in the UK for HER2-low advanced breast cancer blev først udgivet på NHTA.

University of Oslo (UiO) has been assigned the task by DMP, using Norwegian data rather than the British data which is the basis of the current estimate.

Key points:

• The project will start with the specialist health services.

• A first initial report is due by 31 August 2027.

• Eline Aas, professor at Oslo University, expects the first estimates for specialist health services could be ready in that report.

• The work will then continue with municipal health services and National Insurance.

• UiO says different assumptions may produce different estimates, so several alternatives may be presented.

The final report is due by 31 August 2028.

For market access professionals, this is a development to follow closely as the Norwegian prioritisation framework determines the likelihood of a positive recommendation for new innovative treatments.

Read more at https://www.healthtalk.no/nyheter-og-politikk/forste-terskelverdi-anslag-kan-komme-i-2027/214493

Indlægget University of Oslo aims for first Norwegian opportunity cost estimate in 2027 blev først udgivet på NHTA.

Recommended

• Vorasidenib (Voranigo) for patients with a rare, incurable type of brain cancer after surgery.

• Mavacamten (Camzyos) for patients with obstructive hypertrophic cardiomyopathy when a cardiac procedure is not an option.

Clock-stop

• Trastuzumab deruxtecan (Enhertu) for cancer in the gastroesophageal junction and stomach, with discussion of whether the company wants to pursue an alternative price agreement.

• Brentuximab vedotin (Adcetris) for adults with Hodgkin lymphoma, pending a better basis for comparison with standard treatment, especially on long-term side effects.

Not recommended

• Pegcetacoplan (Aspaveli) for rare chronic kidney disease.

• Maralixibat (Livmarli) for itching in Alagille syndrome.

The council also updated the first-line multiple myeloma recommendation, stating BorLenDex should remain first choice for at least 60% of patients.

From December 2026, assessment reports will include a new section on patients’ perspectives.

Read more at https://medicinraadet.dk/nyheder/2026/overblik-beslutninger-pa-radsmodet-den-2-september-2026

Indlægget Medicinrådet issues two green lights and two red lights blev først udgivet på NHTA.

The portal will provide pharmaceutical companies a single place to:

• submit requests for assessment of new medicines

• track status, activities, and milestones

• communicate with The Danish Medicines Council more securely

According to Danish Medicines Council, the first phase covers requests for assessments only. In early 2027, the portal will also accept full applications, including larger files that have been difficult to send by email.

The system was developed in dialogue with representatives from nine pharmaceutical companies, who tested the portal and provided feedback on functions, workflows, and user experience.

The Danish Medicines Council says the portal is part of its broader work to digitalise and streamline assessments of new medicines.

Read more at https://medicinraadet.dk/nyheder/2026/ny-portal-gor-det-lettere-for-virksomheder-at-ansoge-medicinradet

Indlægget The Danish Medicines Council launches new company application portal blev først udgivet på NHTA.

What is new

• A new overview and algorithm give primary care a quick view of recommended pharmacological treatment for type 2 diabetes.

• The material brings together Medicinrådet’s treatment recommendations from the May 2026 guidance.

• It includes information on efficacy, prices, side effects and other relevant details.

• Prices will be updated if they change significantly, for example due to patent expiry or supply issues.

• The overview replaces the previous medicine recommendation in this area and will also be part of the national basis list expected in autumn 2026.

Aim
The stated aim is to give doctors and other health professionals a practical tool that can be used directly in a busy clinical setting.

Read more at https://medicinraadet.dk/nyheder/2026/nyt-overblik-over-laegemidler-til-type-2-diabetes

Indlægget New overview simplifies type 2 diabetes treatment guidance in Denmark blev først udgivet på NHTA.

The **national HTA steering group** — **Medicinrådet**, **Sundhedsvæsenets Kvalitetsinstitut**, and **Lægemiddelstyrelsen** — is inviting relevant stakeholders to a physical dialogue meeting in Copenhagen.

**What will be discussed**
– First experiences with the HTA regulation after around 18 months in force.
– Opportunities, challenges, and possible uncertainties linked to implementation.
– Key issues for further work at EU and national level.

**Meeting details**
– **Date:** Thursday, 3 September 2026, 09:30–12:00
– **Location:** Lægemiddelstyrelsen, Axel Heides Gade 1, 2300 Copenhagen S
– **Registration:** Mandatory by 26 August via the provided link

The session will begin with a short status update on implementation, followed by small-group dialogue and a joint wrap-up.

Read more at https://laegemiddelstyrelsen.dk/da/nyheder/2026/kom-til-dialogmoede-om-de-foerste-erfaringer-med-eus-hta-forordning/

Indlægget Denmark invites stakeholders to EU HTA dialogue meeting blev først udgivet på NHTA.