As mentioned in our previous article1, the EUnetHTA21 previously filled the role of providing joint scientific consultation for applicants to have a dialogue with HTA agencies at an early stage in the development process. This allowed for integration of the different requirements for study design and economic evidence generation. Conversations could centre around clinical trial design, choice of comparators, endpoints, interventions, relevant outcomes, patient populations, quality of life and patient groups for pivotal trials and post-launch evidence generation.
Unfortunately, the contract for EUnetHTA21 will be completed by September 2023 whilst all available slots that were open for JSCs have previously been allocated. Therefore, to bridge the gap between the closure of EUnetHTA21 and the full implementation of the joint EU HTA regulation in January of 2025, the EMA and national HTA bodies will offer health technology companies the opportunity to gain joint scientific advice, in an approach that is referred to as Parallel EMA/HTA body (HTAb) Scientific Advice 2.
The G-BA (Federal Joint Committee, Germany) will function in the capacity of the HTA coordination contact and facilitate the recruitment of HTA bodies. In order to apply for Parallel EMA/HTAb Scientific Advice, manufacturers are required to submit an application to the G-BA at email@example.com. The applicant’s request for scientific advice should provide sufficient information to substantiate the claimed basis for selection, and the criteria used for the selection process will be the same as those used for joint EU HTA regulation, where the following factors must be considered:
- Unmet medical need (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
- Union clinical research priorities
For manufacturers to obtain a place on the programme they should submit an application 1 month prior to the formal procedure start and three months before the intended discussion meeting, further information on deadlines can be found on the EMA website3. When a participant is selected it is a requirement that at least two HTA bodies may actively participate on a voluntary basis. If the minimum number of active HTA bodies is not reached, the request will continue as EMA-only scientific advice. However, as an outcome from full Parallel EMA/HTAb Scientific Advice, health technology developers will receive a scientific advice letter from the EMA and individual written recommendations from participating HTA bodies. Manufacturers should therefore be considering which of their pipeline products will best suit JSCs and begin preparing any necessary applications ready for the scheme beginning in September 2023.
1. Bean S. What are Joint Scientific Consultations and why they are important for manufacturers to consider? Accessed 04/08/2023, https://remapconsulting.com/hta/what-are-joint-scientific-consultations-and-why-they-are-important-for-manufacturers-to-consider/
2. EUnetHTA. Parallel EMA/HTA body (HTAb) Scientific Advice during Interim Period post EUnetHTA 21. Accessed 04/08/2023, https://www.eunethta.eu/jsc/
3. EMA. Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period Accessed 04/08/2023, https://www.eunethta.eu/wp-content/uploads/2023/07/Guidance-on-Parallel-EMA-HTA-body-HTAb-Scientific-Advice-for-the-Interim-Period.pdf