Diverse healthcare structures and reimbursement pathways in Europe present unique challenges for in-vitro diagnostic (IVD) tests companies. Varying reimbursement frameworks, technology assessment processes, and funding mechanisms can complicate the rollout of new diagnostic tests. This White Paper provides a detailed case study on how developers of IVD tests can effectively navigate reimbursement pathways in key European markets using the examples of pathways in Germany and Norway.
Key highlights of this case study include:
- General overview of the market access environment for IVDs in Germany and Norway
- Integration of laboratory test coding within the EBM catalog in Germany and the NLK system in Norway
- Reimbursement milestones for PlGF and sFlt-1/PlGF ratio tests, including recent tariff changes
- Role of the Evaluation Committee and G-BA in Germany and the impact of national HTA evaluations on access and funding decisions
- Example of local-level test adoption despite negative national coverage decisions in Norway
Navigating the reimbursement landscape for IVDs in Germany and Norway requires a nuanced understanding of coding systems, HTA involvement, and regional decision-making authority. Failure to address these factors can lead to delays, revenue loss, and limited patient access. This White Paper delivers actionable insights and strategic considerations to help diagnostic developers accelerate access and funding for IVD tests across Europe.
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