Prototype precision oncology learning ecosystem: Norwegian precision cancer medicine implementation initiative.

Abstract

e13634 Background: Norway, a country with a publicly funded health care system, was in 2018-19 lagging behind with respect to implementation of precision cancer medicine (PCM). Methods: Our approach mid-2019 was very simple and set out three aims: i) To establish access to advanced molecular diagnostics to allow identification and stratification of cancer patients into clinical trials; ii) To increase the volume of clinical trials with a PCM approach to gain experience and build competence; and iii) In parallel work for implementation of PCM into standard of care. Results: In a trans-disciplinary project we worked along four lines: i) Gathered support to have oncologists, hematologists, pathologists and cancer researchers join a nation-wide, bottom-up initiative with a few common priorities; ii) Liaised with executives and regulators in regional health care systems, The Ministry of Health and other public stakeholders and charities to have the top-down approaches meet the bottom-up initiative; iii) Aligned with industry to explore the possibility of a public-private partnership and iv) Coordinated with other PCM initiatives internationally. Over the past two years we have thus built and raised funding for: a) The InPreD-Norway national infrastructure delivering precision cancer diagnostics for patient identification and stratification into clinical trials (publicly reimbursed) and operating the national molecular tumor board; b) the IMPRESS-Norway national researcher-initiated PCM intervention trial (https://impressnorway.com), which opened for inclusion Q2 2021 and runs at all hospitals that treat cancer patients (18 hospitals). The trial is modelled on and coordinated with the Dutch DRUP trial and aligned with similar trials in the Nordic countries; c) the INSIGHT/INCLUDE projects for research on control cohorts, use of real world evidence (RWE), health economics and reimbursement models, and ethics, legal aspects and governance; and d) the CONNECT public-private partnership (https://www.connectnorway.org) for PCM implementation with 29 partners (14 pharma & biotech companies, 9 public partners and 4 NGOs) for interaction with InPreD and IMPRESS initiatives and providing a forum that includes regulators and payors for policy discussions of reimbursement models and regulatory framework. Conclusions: Our experience could serve as a model for building a functioning ecosystem for implementation of PCM. Unique aspects include the nation-wide initiative, the population effect of the diagnostics to be offered and the integration of a public-private partnership.