Early Dialogues

EUnetHTA Open Call for Early Dialogue Requests (July 3, 2020 – August 15, 2020)

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:

• PRIME products
• Complexity of development
• Need for an in-depth discussion with the Applicant about the development plan, e.g. in case of unclear development plan or unexperienced companies
• Major issues with the development plan that would benefit from discussion with the Applicant.

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.

Background

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:

• 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.
• Link EDs to subsequent activities on additional data collection, including the use of patient registries.
• Optimize the interaction with regulators for medicinal products, through parallel EMA-EUnetHTA EDs (Parallel Consultations).

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

• EDs remain confidential and are non-binding for either of the parties involved. Secure systems are used for exchange of documents between company and the EUnetHTA ED Secretariat, as well as between the ED Secretariat and the participating EUnetHTA HTA bodies.
• All participants in an ED (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.
• Some HTA bodies may charge fees for their participation. The EUnetHTA ED Secretariat can provide information on HTA-associated fees.
• Submission formalities are the same regardless of the procedure format. Applicants are advised to review all information available on this website prior to submitting a request.
• All requests (Parallel Consultations and Multi-HTA ED requests) must be made during EUnetHTA’s Open Call for EDs. The Applicant must use the template provided on this website. Additional information on Parallel Consultations and Multi-HTA EDs is available in the corresponding sections of this website.;
• Topics for discussion include all evidence planned to be used in the submission dossier for assessment/re-assessment covering. It is expected that each ED address a combination of the following topics at the same time:
  • Pivotal trial
  • Post-launch studies planned to complete evidence gap anticipated at the time of launch
  • Economic evidence planned as part of future HTA
• The face-to-face (F2F) meeting venue for an ED will depend on the type of request. For Pharmaceutical Products, parallel consultation meetings will take place at EMA (Amsterdam, NL); and Multi-HTA ED meetings will take place either at HAS (Saint-Denis, France) or G-BA (Berlin, Germany).

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