Joint assessments of pharmaceutical products include both relative effectiveness and health economics. The evaluation reports are designed to support the decision processes in the three countries, according to the legal standards and procedures of each country. The three agencies take turns at the different tasks of the evaluation; this leads to higher joint quality and a more time efficient procedure.
The FINOSE collaboration aims at:
- Supporting timely and equal access to medical technologies
- Increasing efficiency in production of assessment reports as well increasing transparency of the assessments
- Decreasing divergence in HTA methodologies and evidence requirements
- Reducing complexity and administrative burden in industry submissions
- Sharing of resources and knowledge between countries
- The collaboration is expected to result in reduced workload and time to market.
The collaboration seeks synergies by enabling communication between the agencies during the normal HTA processes in participating agencies. FINOSE assessment would ideally add only two new features to the current national processes:
- The company submits simultaneously to Fimea, NoMA and TLV (a single submission point is under development.
- The company signs a waiver to allow communication on confidential material between the three agencies and between the agencies and decision makers in respective country.
FINOSE collaboration is not aiming for joint decision making on reimbursement.
Content of the joint assessment report