1315O - Key learnings from building: A precision cancer medicine implementation initiative for Norway

Background

European countries with publicly funded health care struggle with implementation of precision cancer medicine (PCM).

Methods

We set out three aims in 2019: i) To establish access to advanced molecular diagnostics for stratification of patients to trials; ii) To increase the volume of trials with a PCM approach to gain experience; and iii) In parallel work for implementation of PCM into standard of care. Work proceeded along four lines: i) Sign-up to a nation-wide, bottom-up initiative with a few common priorities; ii) Aligning with top-down approaches from the Ministry and regional health care systems; iii) Exploring the possibility of a public-private partnership and iv) Coordinating with other PCM initiatives internationally.

Results

Over the past two years we have built the InPreD-Norway national infrastructure for precision cancer diagnostics allowing stratification into PCM trials with a national molecular tumor board (publicly reimbursed, screened >300 in the first year), the IMPRESS-Norway national researcher-initiated PCM intervention trial (https://impress-norway.no), which opened for inclusion Q2 2021 and runs at all hospitals that treat cancer patients (22 sites, 17 hospital trusts; ), the INSIGHT/INCLUDE projects for research on control cohorts, use of real world evidence (RWE), health economics and reimbursement models, ethics, legal aspects and governance, and the CONNECT public-private partnership (https://www.connectnorway.org) for PCM implementation with 28 partners (16 pharma & biotech, 9 public and 3NGO partners) that provides a forum for policy discussions of reimbursement models and regulatory framework. Key learnings include how to build nation-wide initiatives, the importance of aligning top-down instructions with bottom-up approaches navigating politics and policies at multiple levels, that health economics and reimbursement models are necessary aspects and the need to understand different corporate cultures and create win-wins to make a public-private partnership work.

Conclusions

Unique aspects of our experience include the nation-wide initiative, reimbursement of the molecular diagnostics w. population effect, drug reimbursement in our PCM trial and the public-private partnership model.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Oslo University Hospital.

Funding

This abstract is presented by the authors on behalf of the on behalf of the InPreD consortium and national Molecular Tumor Board, the IMPRESS consortium, the INSIGHT/INCLUDE projects and the CONNECT Public-Private Partnership. Funding for the InPreD national infrastructure for advanced molecular cancer diagnostics for stratification of patients to PCM trials comes from The Regional Health Authorities for South-Eastern, Western, Middle and Northern Norway, the Cancer Society, the Radium HospitalFoundation and other regional funds and testing is reimbursed as health care in Norway. Funding for the IMPRESS-Norway national PCM trial comes from the Norwegian Clinical Treatment Research Programme (KLINBEFORSK), the Norwegian Cancer Society, the Nordic Trial Alliance/NordForsk, as well as company contributions so far from Roche, Novartis, Incyte, Eli Lilly and AstraZeneca and also include collaboration projects with RocheFoundation Medicine and Illumina. Company contributions to IMPRESS-Norway are regulated by separate agreeements with Oslo University Hospital as coordinating institution. Participation in the CONNECT Public-Private Partnership is regulated by a consortium agreement that handles conflicts of interest and regulates interaction with the publicly funded infrastructure InPreD-Norway and the investigator-initiated and publicly funded trial IMPRESS-Norway.

Disclosure

All authors have declared no conflicts of interest.