On June 3rd, FINOSE officially re-launched as JNHB (Joint Nordic HTA-Bodies).
Except for the name, news include a brand new web-page where information and supporting documents are available, and the inclusion of Iceland in the collaboration, through Landspitali University Hospital.
At the launch meeting it was made clear that the aim of JNHB is to increase transparency in the assessment process and to strengthen the collaboration between the Nordic countries, not only through the HTA bodies but also with a link to the Nordic Pharmaceutical Forum, enabling joint Nordic price negotiations.
โโ๐๐ฉ๐ฆ ๐ง๐ข๐ค๐ต ๐ต๐ฉ๐ข๐ต ๐ต๐ฉ๐ฆ๐ณ๐ฆ ๐ข๐ณ๐ฆ ๐ฏ๐ฐ๐ธ ๐ค๐ญ๐ฆ๐ข๐ณ๐ฆ๐ณ ๐ฑ๐ณ๐ฐ๐ค๐ฆ๐ด๐ด ๐ข๐ฏ๐ฅ ๐ด๐ถ๐ฃ๐ฎ๐ช๐ด๐ด๐ช๐ฐ๐ฏ ๐จ๐ถ๐ช๐ฅ๐ฆ๐ญ๐ช๐ฏ๐ฆ๐ด, ๐ฆ๐ด๐ฑ๐ฆ๐ค๐ช๐ข๐ญ๐ญ๐บ ๐ง๐ฐ๐ณ ๐ฉ๐ฐ๐ธ ๐ต๐ฐ ๐ฉ๐ข๐ฏ๐ฅ๐ญ๐ฆ ๐ค๐ฐ๐ถ๐ฏ๐ต๐ณ๐บ ๐ด๐ฑ๐ฆ๐ค๐ช๐ง๐ช๐ค ๐ช๐ฏ๐ฑ๐ถ๐ต๐ด, ๐ธ๐ช๐ญ๐ญ ๐ค๐ฆ๐ณ๐ต๐ข๐ช๐ฏ๐ญ๐บ ๐ฃ๐ฆ ๐ฉ๐ฆ๐ญ๐ฑ๐ง๐ถ๐ญโย says Hannah Norman, Senior Project Leader at Quantify with experience from the current FINOSE process.
The submission dossier template outlines the modelling requirement to fit 5 countries into one model, which might pose a challenge.
However, JNHBโs assessment time of 90 days is considered a significant advantage, compared to the usually longer national assessment timelines.
What still remains unclear is the earliest point of submission for the first โwaveโ of products undergoing the Joint Clinical Assessment (JCA) on an EU level:
Will JNHB need to wait for the JCA report, that will be available 30 days after EMA approval โ or could the process be initiated earlier?
JNHB opens a window between June 10th and July 10th, during which they welcome consolidated feedback on the dossier template and the other launch material.
Reach out to discuss the potential advantages and disadvantages with JNBH versus national processes or the new submission template and model requirements!