โชย ๐๐จ๐๐๐ฅ ๐๐๐๐ข๐ฅ๐ข๐๐ญ๐๐ฌ ๐ฆ๐๐ฒ ๐ฉ๐ฅ๐๐ฒ ๐๐ง ๐ข๐ฆ๐ฉ๐จ๐ซ๐ญ๐๐ง๐ญ ๐ซ๐จ๐ฅ๐ ๐ข๐ง ๐ญ๐ก๐ ๐๐๐๐ ๐ฌ๐ข๐ฆ๐ฎ๐ฅ๐๐ญ๐ข๐จ๐ง ๐๐ง๐ ๐ฌ๐๐จ๐ฉ๐ข๐ง๐ ๐ฉ๐ซ๐จ๐๐๐ฌ๐ฌ:ย EU teams will rely on Nordic affiliates to provide local market information for PICO simulation and preparation.
Moreover, local affiliates may become an important point of influence for โhealth technology developersโ (HTDs) in the PICO process.
Involvement of the HTD in the scoping and PICO creation process, as currently drafted, is very limited.
If this set-up prevails local impact will become very important.
Nordic affiliates can educate local stakeholders which will probably be consulted by the HTA agencies when drafting their PICO suggestions.
โช ๐๐ก๐ ๐ฐ๐จ๐ซ๐ค๐ฅ๐จ๐๐ ๐ซ๐๐ ๐๐ซ๐๐ข๐ง๐ ๐ฅ๐จ๐๐๐ฅ ๐ฌ๐ฎ๐๐ฆ๐ข๐ฌ๐ฌ๐ข๐จ๐ง๐ฌ ๐ข๐ฌ ๐ฅ๐ข๐ค๐๐ฅ๐ฒ ๐ง๐จ๐ญ ๐ซ๐๐๐ฎ๐๐๐ ๐ฆ๐ฎ๐๐ก: HTA submissions in the Nordic countries require health-economic analyses, which are not part of the JCA.
Thus, there will be a large chunk of work left to be done for a local submission in the Nordics.
โช ๐๐จ๐ซ๐ ๐ฐ๐จ๐ซ๐ค ๐ฆ๐๐ฒ ๐๐ ๐๐จ๐ง๐ ๐จ๐ง ๐ ๐ ๐ฅ๐จ๐๐๐ฅ /๐๐ ๐ฅ๐๐ฏ๐๐ฅ:ย Many companies will opt to strengthen their global or EU-level teams to be able to meet the challenges posed by the JCA, especially the data-time challenge: a range of analyses that must be informed, designed, produced, checked and summarized in a dossier in a short period of time.
Once those teams are established they may take on other tasks such as adapting the CE models to local markets.
As anyone working with JCA knows these are educated guesses, they may be true for some but not for all pharmaceutical companies – leave your own thoughts below!
