Joint Scientific Consultations (JSC)
Note: For JA3 Early Dialogues, please go to this link.
EUnetHTA 21 Open Call for Joint Scientific Consultations (JSC) (November 8, 2021 – December 7, 2021)
The EUnetHTA 21 JSC Secretariat is holding an Open Call for Joint Scientific Consultations (JSC) (Parallel Consultations). The Open Call will remain open from November 8, 2021 to December 7, 2021.
To apply, please submit the completed application form (see above) under EUnetHTA21-JSC@g-ba.de.
The EUnetHTA 21 JSC Secretariat is holding an Open Call to fill the first four of eight slots for JSC during EUnetHTA 21. Primary selection of products, based on the Open Call to industry, will be carried out two weeks after the Open Call period to start JSC activities in January 2022. EUnetHTA 21 will be working together with EMA on a more efficient procedure while ensuring the best scientific quality and coordination.
The Open Call will remain open from November 8, 2021 through December 7, 2021. All Applicants will be notified of the JSC Committee for Scientific Consistency and Quality (CSCQ) JSC decision within two weeks after the Open Call period.
EUnetHTA 21 Joint Scientific Consultations (JSC)
JSC provides a non-binding scientific advice, before the start of pivotal clinical trials (after feasibility / proof of concept study), in order to improve the quality and appropriateness of the data produced by the developers in view of future HTA assessment / re- assessment.
EUnetHTA 21 JSCs should enable an exchange between the Applicant and HTA agencies and regulators (EMA) at an early stage in the development process in order to allow the integration of the different requirements across multiple European Member States (e.g. choice of comparators, relevant outcomes, quality of life, patient groups) in the study design (pivotal trials & post-launch studies) and the economic evidence generation plan.
EUnetHTA 21 (2021 – 2023) offers eight or at least, not less than six JSCs (formerly referred to as Early Dialogues) for medicinal products. Prospective and timely advice may allow the Applicant to integrate specific HTA and regulatory needs into the development plan and, therefore, fulfil the evidence requirements of both regulators and HTA bodies at the same time.
The EUnetHTA 21 partners will continue to work with the EMA to improve the consultation processes and their coordination in order to meet the demand for consultations while ensuring the best scientific quality. Detailed information regarding Parallel Consultations is available on the Parallel Consultations page of this website.
The procedure remains essentially unchanged and only minor adjustments are made. An updated guidance document will be made available shortly.
All EUnetHTA 21 JSCs are supported by the EUnetHTA 21 JSC Secretariat, thereby benefiting from HTA scientific and administrative coordination, consolidated HTA comments, a concerted effort to find agreement among the CSCQ JSC regarding specific issues as well as a consolidated document containing EUnetHTA 21’s Final Written Recommendations. Opportunities for closed discussion amongst HTA bodies, and with regulators with mutual understanding, are maximised.
The Committee for Scientific Consistency and Quality (CSCQ) JSC
Within the framework of EUnetHTA 21, the JSC are carried out by the members of the CSCQ JSC, which are: AEMPS (Spain), AIFA (Italy), AIHTA (Austria), GBA (Germany), HAS (France), INFARMED (Portugal), KCE (Belgium), NCPE (Ireland), NIPN (Hungary), NOMA (Norway) and TLV (Sweden). EUnetHTA 21 offers JSCs on clinical and economic evidence generation for pharmaceutical products. EUnetHTA 21 is a one-stop-shop for the involvement of HTA bodies in JSCs with the primary contact point being the EUnetHTA 21 JSC Secretariat (EUnetHTA21-JSC@g-ba.de).
Due to the tender specifications in EUnetHTA 21, the number of products to be selected for the JSC is limited. As the number of applicants is expected to exceed the number of slots, a selection of products will be necessary. With regard to the future HTA regulation, EUnetHTA 21 will apply the same selection criteria as defined in the EU HTA regulation. A prerequisite for a JSC is that the clinical trial (phase II/ or III) has not yet started.
Promising candidates are selected in two steps. Firstly, products have to meet all of the following essential criteria to be considered relevant:
- Unmet medical needs (no treatment or only unsatisfactory treatment available);
- First in class;
- Potential impact on patients, public health, or healthcare systems;
- Significant cross-border dimension;
- Major Union-wide added value; or
- Union clinical research priorities
Secondly, for the purpose of this call, EUnetHTA21 will prioritise the selected products by applying the following additional criteria to support the selection process:
- Targets a life-threatening or chronically debilitating disease; and
- Breakthrough technology*
Oncology products and/or ATMPs and indications for which there is no established guidance for clinical development (i.e. in absence of recent HTA evaluation in similar indication) are also given preferred consideration.
As the selection criteria are applied for the first time in this Open Call, the specification of the selection criteria, their operationalisation and applicability will be further developed in the course of EUnetHTA 21.
In the event that the call is over-subscribed, products which meet all of the listed criteria will be taken into consideration. Further information regarding EUnetHTA 21 JSC, including guidance documents and templates, can be found on the EUnetHTA 21 website. Any inquiries regarding this call or the JSC process itself should be directed to the EUnetHTA 21 JSC Secretariat (EUnetHTA21-JSC@g-ba.de).
General Objectives for EUnetHTA 21 Joint Scientific Consultation (JSC)
EUnetHTA 21 strives to support generation of good quality evidence for proper HTA. To this end, our objectives include:
- Support developers of medical technologies by providing a collaborative approach among a wide-range of European HTAb to provide consolidated advice on their product evidence generation plans while also maintaining individual HTAb positions where needed.
- Supply and incorporate patient and clinical expert contributions in the final recommendations provided by HTAb.
- Optimize the interaction with regulators for medicinal products, through parallel EMA-EUnetHTA 21 JSCs (Parallel Consultations).
General Aspects and Practical Considerations
JSCs remain confidential and are non-binding for either of the parties involved. Secure systems are used for exchange of documents between the company and the EUnetHTA 21 JSC Secretariat, as well as between the JSC Secretariat and the participating EUnetHTA 21 HTA bodies.
All participants in an JSC (including patients/patient representatives and healthcare professionals) are required to complete Declaration of Interest (DOI) and Confidentiality Agreements form. These documents together with the DOI handling procedures are available here.
Applicants are advised to review all information available on this website prior to submitting a request.
All requests must be made during EUnetHTA 21’s Open Call for JSC. The Applicant must use the template provided on this website. Additional information on Parallel Consultations is available in the corresponding sections of this website.;
*Breakthrough technology: Preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint (could include impact on a surrogate or clinical intermediate endpoint or pharmacodynamic biomarker that strongly suggests the potential for a clinically meaningful effect on the underlying disease; improved safety profile or quality of life) or a substantial improvement in practicality or convenience of use or care pathways (organizational impact).