The Joint Nordic process
Horizon Scanning and integration with EU-joint clinical assessment (EU-JCA) process
JNHB collaborates with Nordic Horizon Scanning initiatives and receives information on upcoming new medicinal products and new indications for already approved products that are on the way to the market.
Under the EU HTA regulation, the JCA report must be endorsed within 30 days of European Commission marketing authorization. The JCA report includes an assessment of the relative clinical effect of the new medicine compared to defined comparators.
JNHB uses the JCA report as the clinical basis for joint Nordic HTA, in the same manner as national HTA bodies are required to do. This means that the relative effects and safety reported in the JCA – adapted to Nordic populations and comparators – form the basis for economic modelling. Decisions on pricing, reimbursement, and recommendations remain the responsibility of each individual country.
See figure 1 for a schematic overview of the process.
Figure 1: An outline of how the JCA process connects to the regulatory process, health economic assessments, negotiations and to national decision making. Abbreviations: EMA; European Medicines Agency, PICO; Population, Intervention, Comparator, Outcome, HTD; Health Technology Developer, JNHB; Joint Nordic HTA-Bodies.
The EU-HTA Regulation Supports Joint Nordic HTA by:
Early Identification of Relevant Comparators. The JCA PICO process ensures that relevant comparators are defined for each member state. This enables JNHB to identify products with shared Nordic comparators early, facilitating timely planning for joint Nordic HTAs.
Proactive Engagement with HTDs. With clarity on the JCA scope, JNHB can initiate early and targeted dialogue with Health Technology Developers (HTDs), preparing both parties for a joint Nordic health economic assessment aligned with the JCA conclusions.
Clinical Evidence as a Foundation for Economic Evaluation. The JCA report provides a scientifically validated analysis of relative effects, which can form the clinical basis for joint health economic modelling. This enables the JNHB to focus its efforts on economic evaluation and ensure that national decisions on reimbursement and recommendations are based on transparent and shared evidence.
Facilitating Nordic Harmonization. The HTA regulation and joint Nordic assessments through JNHB support harmonization of HTA methodologies and timelines across Nordic countries, while each country retains national autonomy over decisions on recommendations and pricing.
Read more about integration of JCA into joint Nordic health economic assessments here: