Health, Cancer | Siw had 13 tumors in his brain. Now the family has won the battle to get the medicine approved

(iHarstad) This spring, Arne Jakobsen created a joint for his sister Siw Jakobsen, so that she could afford to try a treatment that could save her life. In June, she started the treatment, and had the medicine approved in August. Now Helse-Norge says yes to everyone being able to get it.

In 2022, the cancer drug Enhertu became a topic on the national debate stage. The medicine gave breast cancer patients with spread new hope, and was approved for use in the USA and Europe in 2021. It was not until October 2022 that the New Methods Decision Forum was satisfied with the proven effect and price – and in an extraordinary emergency meeting they agreed to incorporate the medicine into the public the healthcare system.

Paid myself

Siw Jakobsen is one of those who have been waiting for this medicine to be approved. But when the Decision Forum approved the medication on 27 October, five months had already passed since she started the treatment at Aleris in Oslo with the help of her own funds. After just four treatments, the news came that the cancer tumors had halved in size.

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– I think my doctors and oncologists (tumour expert, editor’s note) thought “oh” when they saw the results. The medicine has worked very well, Siw told iHarstad in September.

When she started treatment, she had 13 tumors in her brain. She was getting worse with each passing day, and felt it both physically and cognitively.

Neither she nor little brother Arne had time to wait for the medicine to be approved, even though they were convinced that an approval would come.

– I said when Siw received the medicine on a special basis in August, that now it will soon be approved for use in the public sector, says Arne on the phone from Kristiansand.

The cancer medicine Tucatinib, together with five other medicines, was also approved in the meeting.

– It is also a medicine that has good results, so that means you have more legs to stand on. Should the Enhertu that Siw has now, against presumption, stop working, and she still needs medicine, then it is an alternative. You get more opportunities the longer you live.

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– We took the load

Arne sees his sister as a role model. She has delivered results that the medicine works, which he believes must have made it more difficult to delay buying the medicine.

– That it has been approved indicates that the results are good. Not just for Siw, but for everyone. In addition, they themselves write that they have agreed on a price. But we took that burden with the 500,000 and thereby also provided AS Norge with another case of research into the business of the medicines.

The question of what is different in January than now, or for that matter February last year, still grinds in Siw’s mind.

– It’s great that everyone now gets it. Very good. Because why let people perish when the medicine is there and available? Why couldn’t they approve it in January, or last year?

Many of the medicines the Decision Forum new methods must assess and approve are medicines that can mean life or death for the people who are waiting for them. Then three months from or until can mean everything.

Siw has no doubts. Had she not, with good help from little brother Arne, started the splicing to get the money to start with the medicine – then it would have been too late to wait for a yes from the Decision Forum.

– If we hadn’t done that, I wouldn’t be here today.

Satisfied with agreement

The decision-making forum for new methods approved the medicine in an emergency meeting on 27 October 2022. Inger Cathrine Bryne, leader of the decision-making forum and CEO of Helse Vest, expressed that they were pleased to be able to introduce this medicine for the treatment of breast cancer that was either inoperable or metastatic HER2 -positive breast cancer.

– We are satisfied that we have reached an agreement with the pharmaceutical company, said Inger Cathrine Bryne in the news story published on Nye metodere.

Inoperable or metastatic breast cancer means when the cancerous tumor cannot be surgically removed or has spread to other places in the body. It is estimated that around 70 patients will be eligible for this treatment each year in Norway.

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Will provide the fastest possible access

The Enhertu treatment was up in the Decision Forum on 22 November 2021, but then as a third-line treatment. At the time of the decision, it was not documented that Enhertu worked better than existing treatment, which was much more affordable – and it was therefore not introduced.

– The reason why we had an extra meeting today was that the matter was almost finished at the previous Decision Forum on 18 October. When an agreement was put in place so quickly after the previous meeting, we wanted to process it straight away, so that the patients have access to the treatment as quickly as possible, says Bryne.

The job for introduction

Decision Forum has always wanted patients in Norway to receive this treatment. At the same time, they must follow the prioritization criteria that the Storting has agreed to, and ensure that the introduction does not affect other patient groups to a large extent.

– A central part of the decisions is the so-called opportunity cost. This means that the Decision Forum must look at the new medicines against what is opted out if the medicine is to be introduced. What we are talking about is therefore an assessment of whether the new medicine is so good that it justifies that money must be taken from other parts of the specialist healthcare service to put it into use, says Bryne.

There is no additional money when introducing new medicines.

– There are many people who have done a solid job to achieve this agreement – both in Hospital Procurement and the Norwegian Medicines Agency, but also clinicians in the hospitals and the secretariat for New Methods. It has been a demanding process and negotiation, but now we have found a solution that ensures access.

First in Scandinavia

Norway is the first country in Scandinavia to introduce Enhertu for this indication. The treatment will be available to patients from 15 November 2022.

– When patients receive medication on a special basis, is this something included in the Decision Forum’s assessments of effectiveness?

– The prioritization criteria mean that the Decision Forum must assess the documentation of the methods, that is the research that the companies deliver; about how well the medicine works, what side effects the treatment has, how serious the disease is, but also how much the medicine costs. The exception scheme for methods that are under assessment is a safety valve that may be relevant for a few patients who meet the conditions (see details here: Untaksordning (nyemetoder.no)). Individual patient exemptions will not normally contribute to the generation of knowledge that can be included in the documentation the company supplies to the Norwegian Medicines Agency.