The Danish Medicines Council has recommended the CAR-T treatment brexu-cel (Tecartus)
3 min læsning
In January, the Danish Medicines Council rejected the CAR-T treatment Tecartus. Now, an agreement in which part of the price depends on the treatment’s effect has paved the way for a recommendation for patients with two types of cancer.
Iben Bøgh Nielsen
- ATMP
- Tecartus
- Brexu-cel
The Danish Medicines Council has recommended the CAR-T treatment brexu-cel (Tecartus) for patients with:
• Acute lymphoblastic leukemia (ALL) – a type of blood cancer
• Mantle cell lymphoma (MCL) – a type of lymphoma
• Mantle cell lymphoma (MCL) – a type of lymphoma
What is interesting is not only the treatment itself, but also the special agreement behind it: Part of the price depends on how well the treatment works.
What is CAR-T treatment?
It begins with the patient’s own immune cells. They are taken from the blood and sent to a laboratory, where they are given a new ability: to recognize cancer cells. They are then returned to the patient, where they can find and attack the cancer cells.
A special pricing agreement made the difference
When the Danish Medicines Council assessed brexu-cel (Tecartus) in January 2026, the treatment was not recommended. The price of the treatment was considered too high relative to the treatment’s uncertain effect.
On September 30, 2026, brexu-cel (Tecartus) was recommended by the Danish Medicines Council on the basis of a new offer from the company for a so-called outcome-based risk-sharing agreement. The special feature of the agreement is that part of the price depends on the treatment’s effect.
In this way, the company and the healthcare system share part of the financial risk.
The agreement terms have been negotiated between Amgros and Gilead. The Danish Medicines Council has then assessed that, overall, there is a reasonable balance between the treatment’s effect, price, and risk. Following the Danish Medicines Council’s recommendation, work will continue on the practical implementation of the outcome-based risk-sharing agreement so that brexu-cel (Tecartus) can subsequently be made available to Danish patients.
Read more about Tecartus here:
Tecartus
Danish Medicines Council’s recommendation
EMA
Questions and answers
What is the purpose of the outcome-based risk-sharing agreement?
The agreement is intended to address the uncertainty about the treatment’s effect relative to the treatment’s costs. Part of the payment is contingent on a predefined clinical outcome being achieved. In this way, the company and the healthcare system share the financial risk.
What is Amgros’ role in the outcome-based risk-sharing agreement?
Amgros negotiates the price and agreement terms and enters into the agreement with the supplier. It is the Danish Medicines Council that decides whether a medicine should be recommended as standard treatment.
What can Amgros disclose about the agreement?
Amgros can describe the type of agreement and the overall principle behind outcome-based risk sharing. The specifically negotiated price, discounts, and commercial terms are confidential.
What is ATMP Denmark’s role in this context?
ATMP Denmark has not been a party to the price negotiations or the decision to recommend the treatment. ATMP Denmark follows developments within advanced therapies and helps share knowledge and experience, including on implementation across relevant stakeholders.
What should a company do if it wants an alternative agreement?
The company submits a request for an alternative agreement model to Amgros and the Danish Medicines Council. Amgros assesses whether the agreement can work in practice and enters into dialogue with the company about the specific agreement model. The Danish Medicines Council assesses whether the agreement sufficiently addresses the uncertainties that may exist regarding the treatment’s effect and cost-effectiveness in connection with the assessment of the treatment as standard treatment in Denmark.
Read more here: Alternative agreements and here: Request for assessment
Read more here: Alternative agreements and here: Request for assessment
What types of alternative agreements are there?
In general, there are economically based and outcome-based agreements. Economically based models can, for example, be price-volume models, budget cap models, and patient initiation models. Outcome-based models link the price to the treatment’s effect.
How many alternative agreements has Amgros entered into?
Amgros has worked with alternative agreements since 2015 and has systematically tracked the number of requests and agreements entered into since 2021.
Find the figures here: Status on the number of requests for alternative agreements
I have questions about Amgros’ alternative agreements. Who can I contact?
Send an email to: medicin@amgros.dk