What is a Parallel EMA/EUnetHTA 21 Joint Scientific Consultation (JSC)?
Parallel EMA/EUnetHTA 21 Joint Scientific Consultations (JSCs) provide 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 Health Technology Developer (HTD) in view of future HTA assessment / re-assessment.
Where can I find more information about EUnetHTA 21?
EUnetHTA 21 was set up to support the future EU HTA system under the Regulation on HTA (EU) 2021/2282. It will build on the achievements and lessons learned from the EUnetHTA Joint Actions. More information about EUnetHTA21 can be found on the website: https://www.eunethta.eu/
What is the Committee for Scientific Consistency and Quality (CSCQ) JSC and who is member?
The CSCQ is in charge of the process that ensures the scientific consistency and quality of activities and deliverables covered by the EUnetHTA 21 service contract. Within the framework of EUnetHTA 21, the JSC are carried out by the members of the CSCQ JSC, which are: AEMPS (Spain), AIFA (Italy), G-BA (Germany), HAS (France), INFARMED (Portugal), KCE (Belgium), NCPE (Ireland), NIPN (Hungary), NOMA (Norway), TLV (Sweden) and ZIN (The Netherlands).
When can an application be submitted? How many open calls are planned during the tender period of EUnetHTA 21?
All requests for participation in a Parallel EMA/EUnetHTA 21 JSC must be made during a EUnetHTA 21 Open Call for JSC. During EUnetHTA 21 two open calls are planned. The first open call has already been closed. The second Open Call EUnetHTA 21 JSC is planned for June-August 2022 and will be announced on the website and on social media channels. More information can be found on the website here.
What is the role of EUnetHTA 21 Joint Scientific Consultations (JSCs) compared to national individual consultations?
EUnetHTA 21 JSC aims to find common positions for the HTA requirements of its members, thus preparing for the implementation of the Regulation on HTA. Nevertheless, national specificities may continue to be made visible in the EUnetHTA 21 consultations and its outputs. Please note that after January 2025, when the Regulation on HTA becomes applicable, in accordance with Article 16 (4) of the HTA Regulation, a Member State shall inform the Coordination Group when it carries out a national scientific consultation on a health technology that has been the subject of a Joint Scientific Consultation. A national consultation should complement and/or address context-specific issues related to the national HTA system of the specific member of the Coordination Group. In case of similar questions for the JSC and the national advice, it is expected that no contradictory positions to the JSC report are provided in the advice provided at national level. It is expected that after January 2025 duplicated full scientific consultations at the national level are not foreseen. Clarification meetings on the national positions are exempted but should not re-address agreed on positions or contradict the centralised advice. Should the scientific knowledge regarding the product substantially change a new JSC should be considered.
Does the consultation always take place in parallel to the scientific advice from the EMA?
During EUnetHTA 21 no HTA-only advice will be offered; all consultations are Parallel EMA/EUnetHTA 21 JSC. Therefore, a common EMA/EUnetHTA 21 template for the submission of a briefing package by health technology developers (HTD) is available. More information can be found in the guidance documents (Guidance on parallel consultation (eunethta.eu)).
For information on the participation of HTA bodies, please contact the EUnetHTA 21 JSC Secretariat (EUnetHTA21-JSC@g-ba.de).
For information regarding regulatory aspects, please contact the EMA scientific advice Secretariat (email@example.com)
What are the selection criteria used to choose products for JSC?
The products are chosen according to the selection criteria outlined in the Regulation on HTA (EU) 2021/2282 Article 17 (3). See below more guidance on the selection criteria during the EUnetHTA 21 service contract.
A) Unmet medical needs (no treatment or only unsatisfactory treatment available);
According to Article 4 paragraph 2 of Commission Regulation (EC) No. 507/2006 unmet medical needs mean a condition for which there exists no satisfactory method of diagnosis, prevention or treatment in the Union or, even if such a method exists, in relation to which the medicinal product concerned will be of major therapeutic advantage to those affected. Especially concerning rare, life-threatening or chronically debilitating diseases. A description of the available diagnostic, prevention or treatment options/standard of care (SOC), including all relevant treatment modalities should be included. The effect of available methods should also be described together with a description of how the medical need is not fulfilled by the available treatment options. Justification will be more convincing if based as much as possible on epidemiological data about the disease (e.g., life expectancy, symptoms and duration, health-related quality of life). The claims could be substantiated e.g., from published literature or registries or healthcare databases.
B) First in class;
For a product to be considered first in class, it must be the first representative of the class of substances for the disease in question, and have a unique mechanism of action. There must be no authorised substance in this class for the disease in question. Overall, the product has to be an innovative technology.
C) Potential impact on patients, public health, or healthcare systems;
For a product to have a potential impact on patients, it must lead to significant improvements in patient morbidity, mortality and quality of life, as well as an improved side effect profile. These benefits may also have a positive impact on health systems as a whole. Therefore, preliminary data on patient-relevant outcomes, if available, should be provided. A high number of patients who would benefit from the product or if the product involves complex administration or manufacturing processes that impose an organisational burden on the healthcare system could also contribute to meeting this criterion.
D) Significant cross-border dimension;
For a product to have a significant cross-border dimension, it must fall within the remit of decision-making bodies and the incidence of the disease must be evenly distributed across Europe or at least similar in more than three countries, or the product must address a serious cross-border threat to health.
E) Major Union-wide added value; or
For the product to show a major Union-wide added value, the clinical studies should be conducted in Europe or at least adequately reflect the European patient population and European health standards. The HTD should provide a value proposition with regard to patient relevant outcomes. The addition of another therapeutic option to the portfolio of existing therapeutic options seems less likely to justify a major Union-wide added value. The disease to be treated by the product should not be highly geographically or ethnically restricted.
F) Union clinical research priorities
A rationale should be provided if the disease to be treated by the product is in the focus of EU clinical research. The Union’s clinical research priorities focus on relevance to the European population. This includes whether there is a major therapeutic need, a current and long-term health threat to the European population or relevant health economic aspects. Examples are the “EU4Health Programme”, “Europe’s Beating Cancer Plan”, “Horizon Europe”, “Innovative Health Initiative”.
Which documents are needed for application?
To apply for a JSC during an open call you need to fill in an application form and send it to EUnetHTA 21 Secretariat. You can find the application form here.
Which documents are needed once the product is accepted for JSC?
You need to hand in a Briefing Book. The template can be found here.
Where can I find information regarding the procedure?
Detailed information can be found in the procedural guidance on the website here.
If a slot for scientific advice at the EMA is already reserved, is it possible to switch to a Parallel EMA/EUnetHTA 21 JSC together with HTA bodies?
Yes, this is possible, but the product has to be accepted during an EUnetHTA 21 open call for JSC first.
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