A record 81 applications for new medicine assessments were received from pharmaceutical companies in 2025, compared with 66 in 2024. The volume created a backlog, delaying the planned start of some assessments.

Following additional funding in October 2025, the Council states that:

• Most applications received in 2025 have now been completed.

• All new assessments are now starting as planned.

• The final delayed assessment has begun, but has been in clock-stop since March 2026 at the company’s request.

The Council expects to decide on that medicine in January 2027.

Alongside the backlog-reduction work, the Council has worked to digitalise and streamline new medicine assessments. This includes a new digital applicant portal designed to make the application process easier for companies.

Read more at https://medicinraadet.dk/nyheder/2026/medicinradets-sagspukkel-er-naesten-vaek-nye-vurderinger-starter-som-planlagt

Indlægget Danish Medicines Council has almost cleared its assessment backlog blev først udgivet på NHTA.

This is a big step, illustrating the increased importance of local RWE in the DMC assessment process. Using RWD from Danish patients to address the gaps and concerns flagged by the DMC in the initial assessment has changed a negative recommendation to a positive recommendation to a the importance of leveraging local RWE.

Danish Medicines Council has recommended mogamulizumab (Poteligeo) for adults with Sézary syndrome or advanced mycosis fungoides, both subtypes of cutaneous T-cell lymphoma.

The council estimates that around six patients per year will be eligible for treatment.

This decision reverses the council’s 2021 conclusion, when mogamulizumab was not recommended as standard treatment. The company returned with a new application including new ITC based on Danish registry data and a lower price.

Key points:

• The treatment may extend survival and help address severe skin itching, which can substantially reduce quality of life.

• The assessment is based on an indirect comparison with Danish registry data.

• There is substantial uncertainty about the size of the survival benefit.

• The council will examine options to follow treatment effectiveness through real-world data.

Reach out to Andreas Bentsen, ab@nhta.com or Asger Lindvig, al@nhta.com if you wish to know more about how to turn local RWE into positive HTA decisions.

Read more at https://medicinraadet.dk/nyheder/2026/medicinradet-anbefaler-ny-behandling-mod-to-sjaeldne-former-for-lymfekraeft

Indlægget Danish RWD supports the positive recommendation for Mogamulizumab by the DMC blev først udgivet på NHTA.

Two years after the EU HTA Regulation entered into force, TLV and SBU will host a joint webinar on ongoing work under the legislation.

The programme includes:

• Background and conclusions from the agencies’ joint government assignment, completed in October.

• National and European progress on joint clinical assessments (JCA), including medical devices.

• TLV’s work on using JCA reports in national decision-making processes.

• Patient involvement in JCA and joint scientific consultations (JSC).

The webinar is aimed at companies, patient representatives and other stakeholders. It will take place digitally via Teams on Wednesday 25 November 2026, from 10:00 to 11:30, and will be held in Swedish.

Participation is free, but advance registration is required. Participants may submit questions in advance or during the session.

Read more at https://www.tlv.se/press/nyheter/arkiv/2026-10-23-tlv-och-sbu-haller-webbinarium-om-den-europeiska-hta-lagstiftningen.html

Indlægget TLV and SBU schedule European HTA legislation webinar blev først udgivet på NHTA.

Among the treatments recommended for introduction:

• Polatuzumab vedotin (Polivy) with rituximab, cyclophosphamide, doxorubicin and prednisone for previously untreated diffuse large B-cell lymphoma in adults, following a new supplier price offer.

• Immunotherapy monotherapy for locally advanced unresectable or metastatic anaplastic thyroid cancer with PD-L1 expression. The off-label treatment was assessed following a proposal from the clinical community.

• Metoxyflurane (Penthrox) for acute pain relief in trauma patients aged over six years.

• Lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory mantle cell lymphoma.

Two treatments were not recommended:

• Octreotide (Oczyesa) for maintenance treatment of acromegaly, as existing treatment alternatives are available and octreotide is substantially more expensive than current standard treatment.

• Belzutifan (Welireg) for adults with von Hippel-Lindau disease, due to its price, and insufficient evidence that the expected health benefit is proportionate to the expected costs. Negotiations with the supplier will resume.

Read more at https://www.nyemetoder.no/aktuelt/innforer-ny-behandling-av-lymfekreft/

Indlægget Norway adopts seven new treatments across cancer and trauma care blev først udgivet på NHTA.

The recommendations covered:

• Rasonque (daraxonrasib) for previously treated metastatic pancreatic adenocarcinoma, following a phased review under EMA’s Cancer Medicines Pathfinder project.

• Foundayo (orforglipron), a once-daily oral GLP-1 receptor agonist for weight management and type 2 diabetes in adults.

• Yuviwel (navepegritide) for children with achondroplasia.

• Two biosimilars: Fovlussea (ranibizumab) and Neuzafy (filgrastim).

• Kizfizo (temozolomide), submitted through a hybrid application, for specified brain tumour indications.

CHMP also recommended indication extensions for Pandemic influenza vaccine H5N1 AstraZeneca, Kyinsu, Talvey, Tryngolza and Tukysa.

Following re-examination, the committee confirmed its recommendation to refuse marketing authorisation for Yartemlea (narsoplimab).

Applications to extend the uses of Ibrance and Truqap were withdrawn.

CHMP did not recommend the proposed paediatric AML use for Mylotarg, but agreed that study data should be included in product information.

It also recommended making Nyxoid available without prescription.

Read more at https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-october-2026

Indlægget CHMP issues six positive opinions in October blev først udgivet på NHTA.

Sykehusinnkjøp says that, so far, no bidder has communicated a decision to withdraw from the cancer tender due to the U.S. “most favoured nation” policy. The tender will take effect on 1 October 2026.

The agency nevertheless describes the situation as uncertain. It has not discussed MFN with pharmaceutical companies’ headquarters, although some local company representatives have said they cannot rule out future changes without specifying them.

Current status:

• Sykehusinnkjøp is working with Nordic counterparts and engaging with companies and other procurement organisations.

• U.S. authorities set out in May 2025 an aim to link U.S. medicine prices to the lowest prices in comparable wealthy OECD countries.

• AstraZeneca has said there is a risk that Norway could be deprioritised for launches, while stating it had not decided to delay or forgo Norwegian launches.

How the policy may affect future access to new medicines remains unresolved.

Read more at https://www.healthtalk.no/nyheter-og-politikk/sykehusinnkjop-om-amerikansk-prispolitikk-for-fremtiden-har-vi-ingen-garantier/214790

Indlægget No withdrawals, so far, from Norway’s cancer tender as a result of MFN blev først udgivet på NHTA.

Jyllands-Posten reports that, during the first nine months of the year, Medicinrådet rejected more than half of new treatments for small patient groups. According to the latest figures cited, Danish patients have access to 18% of EU-approved treatments for rare diagnoses.

The coverage also follows Anton, a young person living with progressive Friedreich ataxia who cannot access the only approved treatment for the condition.

Lif and Sjældne Diagnoser call for debate on the consequences of prioritisation:

• Lif says Denmark must discuss the access level facing people with rare diseases.

• Sjældne Diagnoser says access to new options is important because most rare diseases have no cure or treatment.

• Lif calls for greater acceptance of uncertainty in small patient groups and a new Medicinrådet assessment pathway reflecting their conditions.

The coverage coincides with Lif’s nationwide “Do you get the best medicine?” campaign on access to new and innovative medicines.

Read more at https://www.lif.dk/jyllands-posten-saetter-fokus-paa-adgang-til-medicin-for-sjaeldne-sygdomme/

Indlægget Rare-disease treatment access sparks Danish debate blev først udgivet på NHTA.

• Recommended brexucabtagene autoleucel (Tecartus) for two cancer patient groups through an outcome-based risk-sharing agreement.

• Continued its recommendation for burosumab (Crysvita) in children and adolescents with XLH, while expanding the eligible population.

• Added tezepelumab, depemokimab and omalizumab to the treatment guidance for severe chronic rhinosinusitis with nasal polyps. Their use awaits an Amgros tender and new offered prices.

• Decided on a clock-stop for mepolizumab for uncontrolled COPD while considering a conditional agreement.

• Kept two assessments of trastuzumab deruxtecan (Enhertu) in clock-stop pending further discussions on an outcome-based agreement.

• Did not recommend brentuximab vedotin (Adcetris) for Hodgkin lymphoma, citing unacceptable costs relative to documented effect and uncertainty about long-term adverse effects.

The Council also updated guidance for metastatic renal cancer and approved a protocol for forthcoming guidance on anaemia in chronic kidney disease.

Read more at https://medicinraadet.dk/nyheder/2026/overblik-beslutninger-pa-radsmodet-den-30-september-2026

Indlægget Innovative agreements are gaining further traction in Denmark blev først udgivet på NHTA.

From 1 October 2026, Sweden’s Dental and Pharmaceutical Benefits Agency (TLV) has applied the previously announced new regulations affecting pharmaceutical companies’ reimbursement and pricing applications, as well as TLV’s handling of these cases.

The changes include:

• New general guidelines describing TLV’s criteria for reimbursement and pricing decisions.

• Updated application regulations on the content of reimbursement and price applications. TLV states these largely correspond to the previous requirements.

• Separate regulations for pricing interchangeable medicines and for medicine substitution.

• A new ceiling-price framework for interchangeable medicines, with several options to increase prices and ceiling prices, and three levels to which a ceiling price may be reduced.

TLV states that the new rules are intended to support access to effective medicines and reasonable, sustainable societal medicine costs. Generic substitution is not substantively changed.

An updated company handbook reflects the changes, while several previous regulations and general guidelines have been repealed.

Read more at https://www.tlv.se/press/nyheter/arkiv/2026-10-01-nu-trader-forandringar-for-subvention-och-prissattning-av-lakemedel-i-kraft.html

Indlægget TLV’s new pricing and reimbursement framework is now in force. blev først udgivet på NHTA.

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.