Early Dialogues

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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.

Companies being interested in benefiting from an ED should contact the EUnetHTA ED Secretariat (EUnetHTA-HAS@has-sante.fr).

General Objectives for EUnetHTA WP5A:

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 will be used for exchange of documents between company and ED coordinator, as well as coordinator and HTA bodies.
  • All participants in an ED (including patients/patient representatives and healthcare professionals) have to fill in a Declaration of Interest and Confidentiality Undertaking (DOICU) form. This document, together with the DOICU handling procedures, is available here.
  • Some HTA bodies may charge fees for their participation. The EUnetHTA ED Secretariat can provide information on HTA associated fees. In the coming months, EUnetHTA will implement a fee-for-service model. More information will be available on this page once the system is implemented.
  • Submission formalities vary slightly according to the type of product for which an ED is requested. Applicants are advised to review all information available on this website prior to submitting a request.
    • For Pharmaceutical Products: The request for a EUnetHTA ED must be made in the form of a Letter of Intent. The Letter of Intent is specific to the procedure and the company applying for an ED should use the appropriate template (depending on the type of request: Parallel Consultation vs. Multi-HTA) and follow the appropriate procedure which is available in the corresponding sections of this website: Parallel Consultations and Multi-HTA EDs;
    • For Medical Devices: The request for a EUnetHTA ED must be made via the submission of a draft Briefing Book. The draft briefing book is specific to the ED procedure for Medical Devices and the company applying for an ED should use the appropriate template, available, together with the corresponding Guidance document for Medical Device Early Dialogues, on the EUnetHTA website: EDs for Medical Devices.
  • Topics for discussion include all evidence planned to be used in 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). All meetings for Medical Device EDs will be held at HAS (Saint Denis, France).

Engagement of Stakeholders

EUnetHTA is committed to involving external stakeholders in its work – including EDs. Hearing directly from patients, consumers and health care professionals (HCP) 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.