Author: Sebastian Vinzens, Senior Medical Writer, Germany

Joint Scientific Consultations (JSCs) are primarily designed to provide critical input into the planning of pivotal studies, ensuring that the evidence generated is fit for purpose for a subsequent Joint Clinical Assessment (JCA), i.e., addressing the right PICOs. While the theoretical benefits of JSCs are evident, the reality is more complex: limited slots, clear selection criteria, and a long time between the non-binding results of the JSC and the actual Joint Clinical Assessment (JCA).  Nevertheless, the second JSC request period in 2025 offers a unique opportunity for manufacturers to gain a competitive advantage. 

Why is the 2nd Joint Scientific Consultation request period important?

The primary objective of JSCs is assisting manufacturers in understanding the HTA demands on pivotal trials, optimising trial design for future EU HTA success, and clarifying the potential scope of the future JCA. In 2025, there are only two JSC request periods, where a total of 5 to 7 JSC slots for medicinal products can be applied for. Only products for which pivotal studies have not started yet and which will be subject to JCA are eligible to apply, and the selection criteria (e.g., unmet medical need, first-in-class, major European Union-wide added value) are stringent. However, there is no official prioritisation based on the product being an oncologic drug / ATMP subject to JCA since 2025) or an orphan drug (subject to JCA in 2028). 

The very first request JSC period concluded on 3 March, and the second period will open for submissions between 2 June and 30 June 2025. To apply, manufacturers must complete the respective application form. If a request is accepted, the announcement will be made in mid-July. The official JSC procedure then starts with the draft briefing document having to be submitted between 1 September and 27 October 2025, depending on the exact slot of the 3-4 envisioned consultations. 

Interestingly, authorities have indicated that the industry’s enthusiasm to apply during the first application period was “not overwhelming”. This means that slots for 2025 are still available. While there are ambitions to provide more JSC slots in the future, potentially evolving to a fee-based format, the interest in these slots is also expected to increase as more companies approach their first JCA. 

Potential Risks / Limitations: 

• Selection for a JSC is not guaranteed – there is a risk of wasting resources for preparation 
• Each procedure only requires the active participation of at least two HTA bodies from the European Member States, i.e., the outcome might not be fully representative 
• Manufacturers cannot choose or request specific Member States to be involved, and JSC assessors shall be different from future JCA assessors 
• Input received might be of limited value as PICOs (Population, Intervention, Comparator, Outcome) can change until the start of the JCA 

Potential Opportunities next to study design / PICO aspects: 

• Gaining valuable insights into the usefulness and intricacies of JSCs for future procedures 
• Signaling willingness to adequately prepare for a JCA and establishing relationships with the HTA Coordination Group  
• Initiate stakeholder engagement and create awareness 
• Setting up internal workstreams and communication routines essential for EU HTA processes 
• Identifying areas where additional national advice consultations might be useful or necessary for the product in question 

In summary, while the remaining risks regarding a JSC application during the upcoming request period are primarily related to investment, the potential upsides can be significant. Is it worth it? We highly recommend starting with an assessment to understand whether JSC is the right way for your assets.  Now is the time to act for your best chance to secure a slot in the second JSC request period of 2025.  

At Kintiga, we simplify the complex journey to achieve successful patient access across Europe. By uniting deep local market access expertise, a global perspective, and innovative strategies, we partner with health technology developers to deliver impactful, tailored solutions, maximising both market potential and patient outcomes for orphan drug therapies and beyond. 

If you would like to discuss any of the above insights in more detail, or find out how Kintiga can support you with JSC application or next HTA project, please get in touch via enquiries@kintiga.com