The EUnetHTA ED Secretariat is holding an Open Call to fill the slots available for EDs through May 31, 2021. EUnetHTA will aim to conduct 1 ED per month with a maximum 8 EDs during the EUnetHTA prolongation period. Primary selection of products, based on an open call to industry, will be carried out during the summer in order to restart ED activities in September 2020. The WP5 Lead and Co-Lead partners are working together with EMA on a more efficient procedure while ensuring the best scientific quality and coordination.
The Open Call will remain open from July 3, 2020 through to August 15, 2020. Once candidates have been selected for the 8 available EDs, additional applications may be considered for a ‘reserve’ list.
All Applicants will be notified of the EDWP decision the first week of September for EDs running from September 2020 through May 2021.
TYPES OF ED AVAILABLE
While both Parallel Consultations and Multi-HTA EDs remain available during this period requests for Parallel Consultation will be prioritized in order to maximize impact. Regardless of the type of ED, there is one single procedure; however, there are two different formats the consultation can take, following selection of a product: Written-only format and F2F meeting format.
All EUnetHTA EDs are supported by the EUnetHTA ED Secretariat, thereby benefiting from HTA scientific and administrative coordination, consolidated HTA comments, a concerted effort to find agreement among the EDWP regarding specific issues as well as a consolidated document containing EUnetHTA’s Final Written Recommendations. In the case of Parallel Consultations, opportunities for closed discussion amongst HTA, and with Regulators, with mutual understanding are maximised.
For Parallel Consultations, a preliminary exchange on procedure format and associated organisational topics will take place during the monthly Administrative discussion between EUnetHTA and EMA.
EUnetHTA decision criteria for procedure format
The decision as to which format the procedure will follow will be decided by the EDWP after review of the Applicant’s Draft Briefing Book. This decision will be based on:
The Applicants will be informed of the decision on the procedure format upon reception of the Final Briefing Book by EUnetHTA.
Procedures that do not require a F2F meeting will be approximately 2,5 months in duration starting from reception of the Draft Briefing Book.
Procedures that do require a F2F meeting will be approximately 3,5 months in duration starting from reception of the Draft Briefing Book.
Regardless of the format of a parallel consultation the HTA bodies’ final output remains the EUnetHTA Final Written Recommendation.
Please refer to the Open Call Information Sheet and the dedicated Parallel Consultations and Multi-HTA ED sections of the EUnetHTA website for full details and templates.
Current practices show that while there may be some differences in the evidence required for HTA (i.e. the acceptability of some comparisons and comparators); the information needed to conduct relative effectiveness assessment is often quite similar across European HTA bodies (HTAb).
With the framework of EUnetHTA Joint Action 3 JA3 EDs are carried out by work package 5A (WP5A), which is led by HAS (France) and co-lead by G-BA (Germany). EUnetHTA offers Early Dialogues (ED) on clinical and economic evidence generation for both pharmaceutical products and medical devices. EUnetHTA is a one-stop-shop for the involvement of HTA bodies in EDs with the primary contact point being the EUnetHTA ED Secretariat.
General Objectives for EUnetHTA Early Dialogues:
EUnetHTA strives to support generation of good quality evidence for proper HTA. To this end, our objectives include:
EUnetHTA Early Dialogues
EUnetHTA defines an Early Dialogue as 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 EDs should enable to exchange between the Applicant and these agencies at an early stage in the development process in order to allow for the integration of HTA requirements (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. The main objective of EUnetHTA EDs is to gather and provide the common recommendations on how the drug or device could be developed in order to fill HTA requirements across multiple European Member States. However, when consensus is not possible, the views of participating HTA bodies will be made known to the Applicant.
General Aspects and Practical Considerations
Engagement of Stakeholders
EUnetHTA is committed to involving external stakeholders in its work – including EDs. Hearing directly from patients about the outcomes that matter to them and how the health condition impacts their quality of life/their practice are two areas that are important from an HTA perspective. The procedures for how external stakeholders will be engaged in EDs to share their perspective are available from the EUnetHTA ED Secretariat.
Approaches to External Experts in EUnetHTA Early Dialogues
The EUnetHTA ED Secretariat is actively providing and collecting feedback to/from each participant following the completion of each procedure in order to explain how their contribution was used, to continually improve the process and to identify areas for further development. Based on the feedback we have received from participants, the EUnetHTA ED Secretariat will produce a handbook for external experts (patients, health care professionals) aimed at better informing them about what to expect from their participation in a EUnetHTA ED. The objective is to explain the process of an ED, and to help participants understand what they can expect from their involvement, regardless of the approach used. In addition to this, the ED Secretariat will produce a guidance document for interviewing patients and for chairing a F2F meeting – with a particular section on integrating patient feedback and ensuring that the patient is heard (when present) during the F2F.
The following report has been developed to outline recommendations for Early Dialogues, going forward, based on JA3 learnings:
Recommendations for Early Dialogues based on the experience of EUnetHTA Joint Action 3
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