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Norwegian cancer initiatives receive international attention

Norway is pioneering precision medicine in cancer with three nation-wide initiatives.

Norway is breaking new ground for precision cancer medicine implementation with three national initiatives that are highlighted in the latest issue of the academic journal Nature Medicine. The article shows the broad stakeholder involvement in the initiatives with 116 contributors with 80 different affiliations.

Kjetil Taskén, Head and Director of Institute of Cancer Research at Oslo University Hospital (OUS). Photo: OUS

Kjetil Taskén, Head and Director of Institute of Cancer Research at Oslo University Hospital (OUS). Photo: OUS

“These initiatives represent a triple-win effect,” said Kjetil Taskén, Head and Director of Institute of Cancer Research at Oslo University Hospital and Professor at University of Oslo. “The patients gain access to modern treatments; the researchers can investigate the effect of different medicines on new indications; and the industry can expand the application of their drugs.”

The three initiatives

  • InPreD is a service for precision diagnostics organised as a national infrastructure within the specialist health service. 
  • IMPRESS-Norway is a nation-wide clinical trial evaluating the efficacy of anti-cancer drugs on new indications. 
  • CONNECT is a consortium of public and private stakeholders driving the implementation of precision cancer medicine in Norway. 

Precision diagnostics for patients

Recent developments in precision medicine offer new medical opportunities for cancer patients, which has ignited a debate in Norway about access to more modern treatments. Though equal access is ensured through Norway’s universal health coverage, the medical possibilities challenge public budgets and has led to delayed access for some patient groups.

“There is a growing, worrying split in the health service, where some patients feel compelled to buy diagnostics and treatments at private clinics, when the opportunity does not exist in the public sector,” said Ingrid Stenstadvold Ross, General Secretary of the Norwegian Cancer Society. “These initiatives are spearheading new solutions for seriously ill cancer patients, wherever they live in Norway, and demonstrate what is possible to accomplish with public-private collaboration.”

Norway is one of the first countries in Europe to have a reimbursement scheme, with additional financial support from the regional health authorities to hospitals, for the gene panel test via InPreD. The infrastructure is being set up at all university hospitals in Norway and patients from all Norwegian hospitals can be referred to InPreD. It is currently only available to patients with no other treatment options. The results from the test are discussed in a weekly molecular tumour board that refers patients to clinical follow-up, IMPRESS or other clinical trials.

Åslaug Helland

Åslaug Helland from Oslo University Hospital presented IMPRESS-Norway at Nordic Precision Medicine Forum 2022 in Stockholm. Photo: Åsmund Flobak

InPreD has screened more than 359 patients, of which 67 patients have been included into treatment cohorts in IMPRESS, as of April 2022. An additional 10-15 per cent of screened patients have been assigned to another clinical trial or drugs through compassionate use programmes. This means about 40 per cent of screened patients have received a new treatment option.

“This is about leaving no stone unturned, about finding drugs for patients who wouldn’t have gotten it otherwise. We want to serve the needs that the patients have in terms of modern treatments in the public healthcare system,” said Taskén.

Clinical trial offers new hope

There are currently 16 drugs available in IMPRESS and the goal is to include 23 drugs by the end of 2022. The first pharmaceutical company to join was Roche, providing eight drugs in January 2021. Novartis entered IMPRESS as second partner in 2021, now contributing four cancer medicines.  

“These initiatives offer patients who have exhausted available treatments, a chance for new treatment options and hope,” said Eli Bergli, Medical Head Oncology, Novartis Norway. “Novartis is proud to be part of the implementation of precision diagnostics, so patients can receive a tailor-made treatment for their disease. These innovative partnerships, where public sector, academia and private industry collaborate in finding the best solutions for the future of healthcare, are ground-breaking and offer patients early access to new innovative treatments.”

“InPreD, IMPRESS and CONNECT are core initiatives for the implementation of precision medicine in Norway, and Roche is a proud partner,” agreed Kristin Krogsrud, Healthcare System Partner, in Roche Norway. “In addition to the important goals of establishing genetic testing in clinical practice and generation of scientific data, we see the work around development and piloting novel reimbursement methods as key to be able to improve patient’s access to personalized treatment.”

The four Norwegian regional health authorities recently decided to reimburse drugs in Stage 3 cohorts in the IMPRESS trial. The pharmaceutical industry pays for the first 16 weeks and, if the patient achieves a response after 16 weeks in the trial, the treatments can be reimbursed permanently from the public healthcare system. This is the first mechanism for a pay-for-performance model in precision cancer medicine in Norway ever.

Jan Frich, Deputy Chief Executive Officer at South-Eastern Norway Regional Health Authority.

Jan Frich, Deputy Chief Executive Officer at South-Eastern Norway Regional Health Authority.

“We have had a great and close collaboration with the hospitals in the establishment of a national infrastructure in the Specialist Health Service for precision diagnostics in the cancer field (InPreD),” said Jan Frich, Deputy Chief Executive Officer at South-Eastern Norway Regional Health Authority. “The high inclusion numbers in the IMPRESS-study after referral from InPreD confirm that we are on the way to succeeding in establishing the necessary ecosystem for advanced diagnostics and clinical studies in the Specialist Health Service. This is something we are very proud of.”

Connecting public with private

The third initiative is CONNECT, a public-private consortium consisting of 28 partners, with Oslo Cancer Cluster being the project coordinator. The common goal is to drive the implementation of precision cancer medicine in Norway.

“Oslo Cancer Cluster is a neutral facilitator and an intermediator between public and private. They have been with us since we started working on these national initiatives. Among other things, Oslo Cancer Cluster has been a great supporter in bringing in the pharmaceutical companies in IMPRESS,” said Taskén.

The Norwegian Health Directorate is one of the observers in CONNECT and a coordinator for the National Strategy for Precision Medicine. 

“We follow the work in CONNECT with great interest as it investigates new ways of implementing precision medicine,” said Grethe Foss, Project Leader for Precision Medicine at the Norwegian Health Directorate. 

Taskén stresses one reason for the success of these initiatives is that they are not about profiling individual institutions or people but about coming together with shared objectives. 

“There has been trust and we have been able to act together. The fact that these initiatives now receive international attention can hopefully lead to an expansion of our efforts, that more companies and institutions join, so that more cancer patients gain access to the cancer treatments of the future.”

 

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En forsker undersøker et celler fra en kreftsvulst. Illustrasjonsfoto: AstraZeneca

Nye kreftbehandlinger krever nye samarbeidsformer

I et debattinnlegg i Aftenposten beskriver Sigbjørn Smeland, Steinar Thoresen og Ketil Widerberg hvordan Norge er i en internasjonal særstilling for godt samarbeid i helsesektoren.

This opinion piece was originally printed in the daily newspaper Aftenposten and is only available in Norwegian. / Debattinnlegget sto først på trykk i Aftenposten mandag 9. august, og kan også leses på aftenposten.no.

 

Innføring av nye legemidler for små pasientgrupper tar unødvendig lang tid. Noen blir ikke tatt i bruk i Norge i det hele tatt. Det er en utfordring.

Direktørene i helseforetakene mener hovedgrunnen er at legemiddelprisene er for høye i forhold til nytten for pasientene. Legemiddelindustrien (LMI) mener at store utviklingskostnader gjør at medisinene er dyre. Pasientorganisasjonene påpeker at byråkrati og prestisje går foran alvorlig syke.

Alle har rett. Likevel er ikke løsningen å argumentere videre i hver sin retning. Det trengs et nytt samarbeid mellom industri, myndigheter og pasientorganisasjoner.

Et nasjonalt samarbeid

Hoveddelen av nye legemidler innføres innen kreft. Her er det nylig etablert et nasjonalt samarbeid som heter Connect. Det skal nettopp forbinde alle oss som jobber med kreft, som legemiddelfirmaer, regulerende myndigheter, Kreftforeningen og sykehusleger.

Målet er å finne løsninger for å få tilgjengelig ny medisin til små pasientgrupper. Det kalles presisjonsmedisin. Connect omfatter både avansert diagnostikk og nye behandlingsmetoder. Det har som ambisjon å løfte frem nye prinsipper for finansiering av nye legemidler.

Innføring av presisjonsmedisin er på mange måter et puslespill. Vårt mål er å sette brikkene sammen til et helhetlig bilde som både er bra for pasientene, men som også skaper innovasjon og er innenfor rammene og prioriteringene vi har i Helse-Norge.

Presisjonsmedisin for små pasientgrupper innebærer at utviklingskostnadene deles på færre pasienter. Dette driver kostnadene oppover.

Dagens gullstandard ved innføring av nye medikamenter er randomiserte kliniske studier. Randomisering innebærer at behandlingene vi sammenligner i en studie, blir tildelt deltagerne helt tilfeldig. Det krever store pasientgrupper og er derfor ikke egnet som eneste grunnlag ved innføring av presisjonsmedisin.

Det illustrerer også en fordel med presisjonsmedisin: Kun et utvalg av pasientene vil bli tilbudt behandlingen, basert på analyser av kreftsvulsten. Det hindrer overbehandling, som vi ser i utstrakt grad i dag.

Lære fra hver pasient

Det er derfor nødvendig med felles utvikling av nye løsninger. Det betyr ikke at firmaer får automatisk godkjenning, eller at klinikere får alt de ønsker til pasientene. Regulerende myndigheter får nok heller ikke jobbe på den samme trygge måten som før. Dette blir et krevende samarbeid for alle parter.

Innføring av presisjonsmedisin i helsevesenet er en utfordring de fleste land sliter med. Samtidig er det en enorm mulighet for kostnadsbesparelser og forbedret omsorg. Et stikkord er «midlertidig godkjenning» under forutsetning av fortsatt kunnskapsgenerering.

For vi må lære fra hver eneste pasient. I Norge gjør vi fremskritt, for eksempel gjennom samarbeid om helsedata, tidlig innføring og ny nasjonal handlingsplan for kliniske studier. Myndigheter og industri finner i økende grad løsninger sammen.

Norge i en særstilling

I Norge kan vi etter samtykke samle informasjon fra blodprøver og overskuddsvev. Dette kan kobles opp mot helseopplysninger fra våre unike kvalitetsregistre. Ett eksempel er Kreftregisteret.

Her er vi internasjonalt i en særstilling. Det kan gi oss interesse fra legemiddelfirmaer og bidra til at flere kliniske studier kommer til Norge.

Men det vil kreve en satsing fra våre politikere. I dag mangler infrastruktur i storskala, og da spesielt drift av biobanker. Dette må på plass. Først da kan vi hevde at vi oppfyller målsetningen om at vi skal lære av hver eneste pasient.

Samarbeid mellom offentlig og privat sektor kan gjøre Norge mer interessant for klinisk utprøvning. Det kan igjen gjøre flere legemidler tidlig tilgjengelig for norske pasienter.

Alene redder det ikke liv. Alene skaper det heller ikke en ledende helsenæring i Norge. Men det hjelper betydelig på veien.

 

Artikkelforfattere:

Sigbjørn Smeland, Klinikkleder ved Oslo universitetssykehus, styreleder i Connect

Steinar Thoresen, Leder av Oncology I Norden og Baltikum i Merck, styremedlem i Connect

Ketil Widerberg, Leder av Oslo Cancer Cluster, styremedlem i Connect

Novartis enters IMPRESS

One of the largest pharmaceutical companies enters the precision cancer study IMPRESS in Norway.

Access to a broad portfolio of different medicines that can match molecular findings in a patient is important to succeed with the precision medicine approach of IMPRESS, Norway’s largest cancer study.

“We are very happy that Novartis is now contributing several of their medicines in the IMPRESS-Norway study. This means that Norwegian cancer patients can have more treatment opportunities in the study and that we can treat more patients based on molecular diagnostics. Novartis has many very interesting medicines. We count on more companies joining the study with their medicines soon,” said Åslaug Helland, National coordinator for IMPRESS-Norway and Head of Research at Oslo University Hospital.

 

Åslaug Helland is looking into the camera with a content smile, wearing a blue jacket and glasses.

Åslaug Helland is National coordinator for IMPRESS-Norway and Head of Research at Oslo University Hospital.

 

Six new medicines

Novartis is happy to support the IMPRESS study with six of its cancer medicines to treat up to one hundred patients. The first two Novartis medicines are ready for use this summer and the last four will probably be introduced during the autumn.

A broad collaboration with pharma partners for IMPRESS is important, both to Norwegian cancer patients who have run out of other treatment options, and to build stronger collaborations between public and private actors in the healthcare sector.

“Novartis is proud to contribute to the solutions of the challenges we are facing in the health ecosystem, including the implementation of personalized medicine. Through IMPRESS-Norway and the public-private collaboration in CONNECT, we wish to contribute to a culture for innovative and trusting partnerships with the health service – partnerships that are greater than the capacity and resources of each side alone. We are stronger together,” said Tarje Bergdahl, Nordic Medical Director Oncology Novartis.

Testing off-label treatments

IMPRESS-Norway is a national clinical study in precision cancer medicine, which is testing off-label treatments on cancer patients based on molecular changes in the patient’s tumour. Patients with advanced cancer disease can receive molecular diagnostics through InPreD (Infrastructure for Precision Diagnostics) and are discussed in a national molecular tumour board to provide optimal treatment for the individual patient. Patients who are eligible for the treatments available in IMPRESS are then offered to participate in the clinical study.

All the Norwegian hospitals that are treating cancer patients are part of IMPRESS, in total 17 hospitals, including the university hospitals. Of these sites, 8 are currently open for the study, the rest are opening in August and September. As of 1 July, 40 patients were included in the molecular profiling with a 500 gene panel, 18 patients were discussed in the national molecular tumour board and 7 patients were included with different treatments in the IMPRESS study.

Read more

  • The consortium CONNECT is linked to the clinical study IMPRESS and the Infrastructure for Precision Diagnostics InPreD. CONNECT has facilitated dialogue meetings between industry representatives and the two mentioned national initiatives IMPRESS and InPreD. CONNECT is coordinated by Oslo Cancer Cluster. Read more about CONNECT, the partners and recent activities here: The CONNECT website
  • Dagens Medisin has written about Novartis entering IMPRESS (in Norwegian) here: Flere legemidler tilgjengelig i IMPRESS-studien

 

New partners join precision medicine consortium

Five new partners have joined CONNECT, a public-private consortium driving the implementation of precision cancer medicine in Norway, coordinated by Oslo Cancer Cluster.

The five latest additions to the public-private consortium CONNECT include the Norwegian Directorate of Health (Helsedirektoratet), the Norwegian Medicines Agency (Statens Legemiddelverk), and pharmaceutical companies Lilly, MSD and Janssen.

The Norwegian Directorate of Health and the Norwegian Medicines Agency are the most recent public partners to join this unique national public-private partnership.

“The Norwegian Medicines Agency is happy to have joined CONNECT as an observer. Personalised medicine is currently high on the agenda, and we look forward to the extended opportunity for dialogue with national and international stakeholders, provided by CONNECT,” said Karen Marie Ulshagen, Strategic Director, Timely Access, Norwegian Medicines Agency.

The ten pharma companies who co-founded CONNECT in December 2020 are now accompanied by Lilly, MSD and Janssen, all sharing the same vision to drive the implementation of precision cancer medicine in Norway.

“CONNECT represents a collective effort between partners in the healthcare industry (private, public and voluntary sectors) and has the potential to build a culture which fosters innovation, collaboration and development of competency with the increased benefit for the individual patient as the core priority,” said Hilde Enserink, interim Medical Director and Oncology Lead, MSD Norway.

“With our focus on precision cancer medicine in our pipeline and our belief that dialogue and co-operation between all stakeholders is the right way forward, CONNECT fits very well with our purpose in Janssen. In the end though, it is the patients that matter the most and we hope CONNECT will eventually lead to a wider and earlier access to new precision cancer medicines for cancer patients in Norway,” said Sverrir Valgardsson, Medical Affairs Lead, Janssen Norway.

Ravinder Singh, Senior Clinical Research Scientist, Nordic Medical Lead, Lilly, complemented: “The implementation of precision medicine in Norway is a very important measure for Norwegian cancer patients, but at the same time very challenging considering the technological, medical, and regulatory aspects. A united front to facilitate precision medicine, where the pharmaceutical industry is seen as a partner rather than a financial contributor, will be of use for the academic milieu, the industry itself and for Norwegian cancer patients.”

Other CONNECT partners are the Norwegian Pharmaceutical Industry Association (Legemiddelindustrien – LMI), the Norwegian Cancer Society (Kreftforeningen), the Norwegian Institute of Public Health (Folkehelseinstituttet) and the tech companies NEC and PubGene. The unique blend of participants enables CONNECT to address current obstacles facing precision cancer medicine in Norway.

Gathering experts to find new solutions

CONNECT was initiated by 22 founding partners in December 2020 and is coordinated by Oslo Cancer Cluster.

Since its establishment, CONNECT has carried out its activities through four working groups gathering experts from the different university hospitals, authorities, industry and the Norwegian Cancer Society. The working groups had regular digital meetings since February 2021, where they created a joint understanding of the challenges and opportunities associated with the introduction of cancer precision medicine in a public healthcare setting and started the first initiatives.

CONNECT has also offered open, educational meetings and some are still available to be viewed via the CONNECT webpage Recordings of past events.

The next public meeting will take place during Arendalsuka and be held in Norwegian. The topic is How to succeed with precision cancer medicine – Research and collaboration that brings us further. The event will include conversations about emerging research and treatment opportunities for cancer patients in Norway.

Collaborating with national clinical study

CONNECT has facilitated dialogue meetings between industry representatives and the national initiatives IMPRESS-Norway and InPreD.

IMPRESS-Norway is a national clinical study in precision cancer medicine, which is testing off-label treatments on cancer patients based on molecular changes in the patient’s tumour. Patients with advanced cancer disease can receive molecular diagnostics through InPreD (Infrastructure for Precision Diagnostics) and are discussed in a national molecular tumour board. Patients who are eligible for the treatments available in IMPRESS are then offered to participate in the clinical study.

The pharmaceutical company Novartis agreed this week to contribute six new medicines to IMPRESS-Norway to treat up to one hundred patients. More information about this will be published in English next week.