Norway has approved treatment for HER2-low
From 1 November, all Norwegian women with HER2-low breast cancer can be treated with the breast cancer medicine Enhertu (trastuzumab deruxtecan, T-DXd) at public hospitals in Norway.
In Denmark, the treatment is still subject to assessment by the Medical Council, and therefore Danish women cannot currently receive the treatment.
Since the European Medicines Agency (EMA) approved Enhertu for patients with HER2-low metastatic breast cancer in January this year, it has been fast to get it approved in the Norwegian Decision Forum, which corresponds to the Danish Medicines Council. From 1 November, all Norwegian women with HER2-low breast cancer can receive the treatment at the public hospitals.
"This is a fantastic decision for many Norwegian patients with metastatic breast cancer. About half of them are HER2-low, and they now have access to a new treatment alternative, from which it was not previously thought that they would benefit," says Alina Carmen Porojnicu, oncologist and senior physician at Drammen Hospital outside Oslo, to Oncological Journal in Norway.
The Norwegian Breast Cancer Association is pleased that the approval has gone faster than they had expected. Ellen Harris Utne, who heads the association, insists that the Decision Forum writes that the decision was taken after a thorough consideration of the human consequences.
"... We hope that this is the start of a way of thinking where you don't just look at price and utility but also at the people behind the diagnosis," she says to Onkologisk Tidsskrift.
What does the Medical Council want?
But in Denmark it does not go as quickly. Here, the application to use Enhertu has been under assessment by the Medical Council since February this year.
"A possible approval by the Medical Council will come in the spring or summer of 2024 at the earliest," says oncologist Ann Søegaard Knop, who is chief physician and medical director of the Oncology Clinical Research Unit at Rigshospitalet and chairman of the medical committee of DBCG (Danish Breast Cancer Group) to Medical Journals.
The long case processing times in the Medical Council have led Anja Skjoldborg Hansen, who is chairperson of the Breast Cancer Association, in a debate paper in the Alting, to call Denmark a developing country in terms of treatment when it comes to breast cancer, and she continues:
"...Politicians have made the question of access to cancer medicine a question of money rather than a question of what level of treatment we want to be able to offer our citizens."
The Medical Council rejects the criticism in a speech in the Alting on 5 October, where they also explain that the case processing time to assess Enhertu is due to the specialist committee for breast cancer being extra busy:
"..Shouldn't the assessment be ready now? Yes, but the case is "in the queue" because there are other assessments underway in collaboration with the specialist committee for breast cancer, which is one of the Medical Council's busiest specialist committees. If we moved this case forward, other breast cancer patients would have to wait instead," write the chairmen of the Medical Council in the debate entry and call for a debate on prioritization within health.
Refusal of treatment
Oncologist Ann Søegaard Knop explains that 45-55 percent of women with breast cancer have HER2-low and this is the group that will be able to be treated with Enhertu. Oncologists can apply to the regional drug committees to offer specific patients a treatment that is not approved in Denmark. Ann Søegaard Knop has tried this several times, but without success. One of these patients is Lena Rosenkilde, who chose to pay herself to receive the treatment in Sweden. She is still in the process, and struggles at the same time to afford the treatments, which cost around DKK 80,000 per treatment. walk. She has had six treatments so far.
"It seems unethical that you refuse to pay for a treatment that you know is effective," says Lena Rosenkilde. She and her oncologist, who is Ann Søegaard Knop, have otherwise been able to document that she already responded well to Enhertu after the third treatment in Sweden, but it still ended with a refusal from the regional pharmaceutical committee in the Capital Region, when the doctor applied for permission again.