With the new EU Health Technology Assessment (HTA) Regulation, significant changes are effective for Health Technology Developers (HTDs). One of the critical components of this new regulation is the Joint Scientific Consultation (JSC), a collaborative framework between HTDs and EU HTA bodies (HTAb) designed to streamline and enhance the clinical development of medicinal products and medical technologies.
It is also possible to streamline the processes for seeking regualtory advice in parallel with the HTA. The JSC is for new technologies in areas where there is a high unmet need (e.g. no other treatments available) and with a high level of uncertainty.
What is a Joint Scientific Consultation?
The consultations aim to provide a more cohesive direction for clinical trials, ensuring that they meet the diverse evidence requirements of different European markets more efficiently for a subsequent JCA.
By engaging in JSC, companies can align their clinical development plans with the expectations of various national HTA bodies, thus facilitating smoother market access post-approval.
JSC request periods and timelines
There will be two request periods per year, and in 2025 the number of slots will be very limited, with an anticipated maximum of 5-7 slots for medicines and 1-3 slots for medical devices.
Requests for JSCs should only be submitted during the request periods published in the Annual Work Programme of the HTACG. In 2025, these periods are:
- 3 February to 3 March 2025 for medicinal products only
- 2 to 30 June 2025 for medicinal products and medical devices
JSC procedures and eligibility critera
Preparations for the JSC should start already in the early phase work. This is the time to generate the evidence to meet the criteria for being granted a slot for JSC. Demand is expected to be high, and the number of slots is limited. As a result, the standards are highly set for applicants and HTDs are wise to prepare convincing cases.
The eligibility criteria for JSCs centre around:
1. Products in areas with a high unmet need or uncertainty
2. Products in areas where there is no (or unsatisfactory) standard of care
Given that the JSC application must demonstrate how the product meets all the eligibility criteria, the importance of presenting satisfying evidence from the early phase work is clear.
HTDs who have gone through JSC are wise to review the feedback in detail. All internal stakeholders should be on the same page regarding any modifications to the clinical trial design and evidence generation. JSC advice needs to be included in the JCA dossier and HTDs must be able to present argumentation for any recommendations that have not been implemented. Implemented advice should also be documented.
JSC responsibilities and opportunities
Companies opting to engage in JSC need to prepare thoroughly and start early. The process requires the submission of detailed clinical development plans and an understanding of how these align with the needs of different HTA bodies.
JSCs provide the opportunity to discuss key concerns with a broader range of stakeholders including the JSC assessors (HTA bodies), clinical and patient experts, as well as experts in the relevant disease or therapeutic area.
HTDs must be prepared to communicate and justify their development strategies and be open to adapting them based on feedback received.
Are you looking for JSC support?
Arex has the experience and expertise from previous scientific consultations to help you prepare and gain valuable insights through JSC.
Our Market Access team and Regulatory Affairs team are ready to support your JSC.
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