I (Ingvild Kjerkol, Minister of Health and Care, journ.anm.) refer to a letter from the Storting’s Health and Care Committee dated 29 September 2023, attached representative proposal from representatives Bård Hoksrud, Sylvi Listhaug, Morten Wold, Gisle Meininger Saudland, Dagfinn Henrik Olsen and Silje Hjemdal about offering MS patients stem cell treatment in Norwegian hospitals. The representatives put forward three proposals: 1. The Storting asks the government to inform the Storting about progress and funding for the national RAM-MS study on stem cell treatment, in line with the Storting’s decision when considering Representative proposal 221 S (2020–2021) (decision no. 991 (2020 – 2021)). 2. The Storting asks the government to come back to the Storting with a plan for how seriously ill patients who fall outside the RAM-MS study can be offered stem cell treatment through the exception scheme, when national medical expertise recommends such treatment. 3. The Storting asks the government to ensure that stem cell treatment is introduced for MS patients in Norwegian hospitals in line with professional recommendations from national medical expertise, for patients who cannot be included in the RAM-MS study. I would first like to emphasize that I share the representatives’ commitment to people with multiple sclerosis (MS). People must have safe and good health and care services regardless of their finances and residential address. And we use new treatment methods. Whether new methods can be used in the public health service depends on whether it can be documented that they are safe, that they bring benefit to the patient, and that they are cost-effective compared to available treatment. This assessment of new treatment methods is done in a systematic way through the New Methods system, regardless of diagnosis or method. The prioritization criteria benefit, seriousness and resource use, which the Storting has agreed to, form the basis of the final assessment. Anyone can submit a proposal for a method assessment for the introduction of methods in the specialist healthcare service by filling in a proposal form. The regional health organizations decide which treatment methods are to be included in the specialist health service offer, which the Storting has agreed to. The decisions are made on the basis of professional assessments and based on available knowledge. The offer given to patients and users must be justifiable. The regional health organizations are working to reduce the processing time in the New methods system, for example where the processes can be made more efficient or simplified. At the same time, the regional healthcare organizations are required by law to arrange their services in line with the priority criteria. Therefore, effectiveness, safety and cost-effectiveness must be documented with scientifically robust methods. Clinical studies of good quality precisely contribute to a solid basis for decision-making. Stem cell treatment for patients with MS was first assessed in the New Methods system in 2016. Based on a complete method assessment from the Institute of Public Health (FHI) and a recommendation from the National Expert Service for MS, the Decision Forum decided that all patients who are offered autologous stem cell transplantation in Norway should be included in a clinical study. This was the background for the national study RAM-MS, which started in 2018. In 2021, the system for New methods commissioned an updated survey of documentation. FHI carried out a simplified method assessment which showed that there was one completed study that had several methodological weaknesses, and that there were several ongoing studies. In light of the responsibility that the Storting has given the regional health undertakings, it will not be right if the Storting decides that certain patients should be able to receive concrete treatment which, as of today, is not considered to meet the requirements for introduction into the public health service. It is important to emphasize that there has been a major development for patients with MS in recent years. There have been many new drugs in the treatment of MS. More patients receive more effective treatment, and this highly effective treatment is started faster than before. Many patients with MS therefore benefit greatly from the new drugs, which slow down the development of serious disease and thus improve the prognosis. I have asked Helse Vest RHF to obtain an updated status for the RAM-MS study. Helse Vest RHF has been in dialogue with Helse Bergen HF and the steering group for the RAM-MS study, which has sent the ministry its assessments. These are included in the answers below. Proposal: 1: The Storting asks the government to inform the Storting of progress and funding for the national RAM-MS study on stem cell treatment in line with the Storting’s decision when considering Representative proposal 221 S (2020-2021) (decision no. 991 (2020-2021)) .The national study is a multi-centre study with four regional centers in Norway, two regional centers in Sweden, one center in Denmark and one in the Netherlands. The study is led by Helse Bergen HF, Haukeland University Hospital. The steering group for the RAM-MS study states that 88 patients with relapsing-remitting MS are included in the study. According to the plan, a total of 100 patients will be included. The study can be expected to be fully included in May/June 2024 if the inclusion continues at the same pace. All study patients are followed for two years, and the study data is planned to be compiled and published in May/June 2026. If statistical power permits, the steering group states that the results can be published earlier. Of the included patients so far, 78 out of 88 patients are from Norway. According to the steering group, this is significantly more than expected at the start of the study, when 50 Norwegian patients were estimated. The reason is low study inclusion from the foreign study centres, mainly due to a long-term break in the stem cell transplant offer during the corona pandemic. In RAM-MS, foreign study centers pay for the study treatment themselves, including the half of study patients who receive autologous hematopoietic stem cell transplantation (aHSCT). The increased number of Norwegian study patients has resulted in increased study costs. The additional grant for the study of NOK 20 million through the Program for clinical treatment research in the specialist healthcare service, after the Storting’s consideration of the state budget for 2021, meant that more Norwegian patients could be included. As a follow-up to representative proposal 221 S (2020-2021) (resolution no. 991 (2020-2021)), the ministry requested, in addition to the assignment document for 2021, that the regional health organizations should ensure that patients with MS receive good information about the possibility of participate in clinical trials of stem cell treatment in Norway. They were also asked to consider strategies to increase the number of patients participating in the RAM-MS study. The result of the latter can be seen from the steering group’s briefing reproduced above. With regard to ensuring better information about clinical studies for patients with MS, it was shown in the annual report to the ministry that this had been followed up through the management line of the health institutions. Helse Vest RHF also showed that the research center for clinical treatment in neurological diseases, NeuroSysMed, Haukeland University Hospital and the University of Bergen, have jointly developed Med.hjelper – a platform that will provide information about clinical studies to patients and relatives. The regional health authorities’ follow-up of assignments given on the basis of measures in the national action plan for clinical trials will, in addition to this, help to increase information and the recruitment of patients for clinical trials. The government is closely following up on these measures, as well as the action plan as a whole. Proposal 2: The Storting asks the government to come back to the Storting with a plan for how seriously ill patients who fall outside the RAM-MS study can be offered stem cell treatment through the exception scheme, when national expertise recommends such treatment. Treatment methods that are for assessment in the system for New methods shall, as a general rule, not be part of the offer in the specialist health service. The System for New Methods has established arrangements to exceptionally give individual patients or patient groups access to methods that are being assessed. The exemption scheme does not apply to methods where there is a decision from the Decision Forum. Stem cell treatment was offered through the exemption scheme in the period 2015-2016, i.e. pending the method assessment from FHI. The treatment cannot be offered to MS patients via the exemption scheme, as it is not under assessment in the New Methods system. However, it can be offered as trial treatment, in line with the national principles for trial treatment. When the results from the RAM-MS study are available, it may be relevant to assess whether the treatment should be introduced as ordinary treatment – and then through a new assessment in the System for New Methods. Proposal 3: The Storting asks the government to ensure that stem cell treatment is introduced for MS patients in Norwegian hospitals in line with professional recommendations from national medical expertise, for patients who cannot be included in the RAM-MS study. I would like to emphasize that it is not the government that introduces treatment methods in Norwegian hospitals. Decisions about the content of specialist healthcare services are within the responsibility of the regional healthcare organisations. Again, I would like to refer to the principles for prioritization that the Storting has agreed to, and the professional assessments that have been made in this case. Decisions in the system for New methods can be reassessed if new information is added that is relevant to elucidate the usefulness, safety and cost effectiveness of a method. I understand that the documentation base in this case is in development, and have confidence that the health organizations and professional communities take their responsibility for the best possible treatment offer for MS in Norway. The steering group for the RAM-MS study has stated in its briefing to the ministry that there is a consensus in the neurological professional community that there is a need to be able to offer aHSCT to individual patients with relapsing-remitting MS who do not meet the inclusion criteria in the RAM-MS study. These are exceptions that are made in case of particularly aggressive disease activity, when established treatment is contraindicated or not tolerated due to side effects and/or there is reason to believe, based on documentation, that the effect of aHSCT treatment will be significantly greater than for the group as a whole. The patients must also be assumed to tolerate the treatment. Such patients have been assessed and given treatment at Helse Bergen HF, Haukeland University Hospital. The steering group states that some patients with MS in recent years have also received stem cell transplantation at Oslo University Hospital HF. It is therefore not the case that no patients are offered stem cell treatment as trial treatment outside of the RAM-MS study, but this is done after an individual assessment. I am informed that the relative proportion of MS patients who have received aHSCT in Norway is not significantly different from Sweden or Denmark. It is emphasized that other public health services in Europe also do not offer the treatment to a greater proportion of MS patients than is the case in Norway. The steering group for the study assumes that this is connected to the documentation basis. Until the documentation from the RAM-MS study is available, the professional community at Helse Bergen HF, Haukeland University Hospital, therefore considers that the total number of MS patients with an indication for aHSCT will still be low. Thus, there is sufficient capacity at Helse Bergen HF; Haukeland University Hospital, to treat these. Helse Vest RHF supports the professional community’s assessment and believes that the treatment is available for relevant patients. I believe that it would be unwise to go against these assessments and therefore do not support the representatives’ proposal.
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Both Tommy Herredsvela and Line Flesjaa have MS – but Line has had stem cell treatment – Rogaland
