Snapshot

The Joint Nordic HTA-Bodies (formerly FINOSE) pathway has been developed by the of Nordic Region.

This pathway can be used where FINOSE is a Nordic collaboration in which HTA bodies from all the five Nordic countries jointly perform HTA for new and innovative pharmaceuticals..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Denmark Finland Iceland Norway Sweden

The Joint Nordic HTA Bodies (JNHB) process can be initiated through the following pathways: • JNHB can contact health technology developers (HTDs) directly regarding products, identified through JNHB’s horizon scanning procedure, likely to be suitable for joint assessment. • The HTD can contact JNHB regarding products in their pipeline that they consider relevant for joint assessment. • Suggestions for products for joint assessment can also be put forward by the Danish Medicines Council, the NT-council in Sweden and Nye Metoder Bestillerforum in Norway. After initial contact, the JNHB team can arrange a meeting with the HTD to address general questions regarding the JNHB process, timelines and required documentation. It is suitable for the HTD to send the PICO proposal 2-3 months before dossier submission, to allow planning of the assessment, and enable the assessment within the given timeframe. However, this timeframe is flexible and should be decided on jointly between the HTD and JNHB. A JNHB assessment is a collaboration between the involved HTA bodies. This means that the involved HTA bodies have agreed on the conclusions presented in the joint assessment report, regardless of whether participating as assessor, co-assessor or reviewer. The JNHB assessment target time for assessment is 90 days.