Gaining early external HTA advice is critical for bringing innovative medicines to market.
Selecting the right route and timing of advice is an essential component of this and will differ for each asset. We can support you, thinking strategically which of the national HTA bodies to engage or whether to apply for Joint Scientific Consultation.
We also recognise that some organisations wish to gain external input and validation in a confidential, informal way. We therefore offer a mock JSC simulation with external payers with the possibility to include regulatory experts to guide your development programs.
If you would like to discuss with one of our team, please contact us
Guidance for the selection of Medicinal Products for JSC
Procedural guidance for JSC on Medicinal Products
Briefing document template for JSC for Medicinal Products
Briefing document template for parallel HTACG/EMA JSC for Medicinal Products
The framework for JSC was established in Regulation (EU) 2021/2282 (EU HTA). It enables Health Technology Developers (HTD) to obtain scientific consultation during the planning phase of pivotal studies to establish the evidence needs for subsequent Joint Clinical Assessment (JCA)
Clear guidance has been provided on the selection of medicinal products for JSC and it is understood that the number of products that can be assessed in 2025 will be limited, with plans to increase capacity in subsequent years.
