The Regional Health Authorities in Norway has recently decided to reimburse patients who are included in the first expansion cohort in IMPRESS-Norway according to a pay-for-performance model.

IMPRESS-Norway is a precision medicine trial that tests approved drugs on new indications based on genetic changes in the patient’s tumor. The study started in April last year, and so far more than 50 patients have been offered treatment (identified in the National Molecular Tumor Board among 250 patients who have undergone extended molecular profiling). Currently IMPRESS-Norway is supported by Roche, Novartis, Eli Lilly & Company and most recently also Incyte.

Read more: Norwegian public-private agreement for precision cancer medicine

In the first phase, up to twenty-four patients can be included in a treatment cohort defined by specific biomarker (molecular changes), drug and tumor diagnosis. If five or more patients of these first twenty-four have clinical benefit from treatment (not progression) after sixteen weeks of treatment, then the effect of the treatment needs to be further investigated in a larger group of patients, – a so-called expansion cohort. A proposed model for expansion cohorts is a phase 2 study in which the pharmaceutical companies give the drug to patients for the first sixteen weeks, and then the public takes over the cost of the drug for the patients who have clinical benefit (pay for performance). It is this model that the Regional Health Authorities have approved for Norway.

Sharing data across borders

IMPRESS-Norway recently agreed to share data with similar precision medicine studies in the Nordic countries and the Netherlands (DRUP) in order to more quickly collect efficacy data on small patient groups with specific mutations. In the wake of this, IMPRESS-Norway has now been invited by the Dutch DRUP study to participate in an expansion cohort for the treatment of patients with inactivation of both alleles of the genes encoding BRCA1 and / or BRCA2 (bi-allelic) with PARP inhibitors (olaparib). This expansion cohort will open based on results from twenty-four patients who have been treated in the DRUP study. The Regional Health Authorities has granted a group exemption for patients who will be included in this expansion cohort in IMPRESS-Norway if it is initiated in Norway. This means that the public sector takes over the cost of the drug for those patients who have clinical benefit after sixteen weeks of treatment in this expansion cohort.

Precision cancer medicine initiatives in Norway

Norway has initiated four interconnected initiatives in precision cancer medicine (PCM) that will ensure infrastructure and collaboration on diagnostics, clinical trials, implementation of advanced precision medicine and use of health data, e.g., for health economics analysis. These are InPred (Infrastructure for Precision Diagnostics), IMPRESs (Improving public cancer care by implementing Precision medicine in Norway), INSIGHT (Regulatory framework for implementing precision medicine into the Norwegian health care system), and CONNECT (Norwegian Precision Cancer Medicine Implementation Consortium).

Public-Public-Private partnership

The opening of the first expansion cohort in IMPRESS is an example of how important public-public-private partnerships are for precision cancer medicine. The topic of expansion cohorts has been discussed in the established partnership for precision medicine called CONNECT, where representatives from the hospitals, the industrial partners and the authorities participate. Through this collaboration all stakeholders collaborate in order to test new models for implementation of precision cancer medicine.

The CONNECT consortium has been initiated by 22 founding partners in December 2020, attracted 6 additional partners since then and is coordinated by Oslo Cancer Cluster. CONNECT gathers all Norwegian university hospitals, pharmaceutical and technology companies, the Norwegian Cancer Society as a patient organisation, the Norwegian Institute of Public Health, the Norwegian Directorate of Health, and the Norwegian Medicines Agency. The consortium is open to include new partners from the industry and public sector.

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