Early Dialogues FAQs
General Questions (e.g. pathways, fees etc.):
Q: In case of a request for a Parallel Consultation, are products that are not selected still eligible for a regular Scientific Advice with EMA or a national early dialogue?
A: Yes. Requests for parallel consultation that are not accepted by EUnetHTA may still be eligible for a regular EMA Scientific Advice procedure; it is for this reason that all requests for PC must be copied to scientificadvice@ema.europa.eu. Likewise, it is possible that a request not accepted for a PC may be eligible for a national-level ED.
Q: At what phase of product development may a company request an Early Dialogue?
A: Requests for EUnetHTA Early Dialogues should be made prior to the initiation of the pivotal trial(s).
Q: Does a request submitted at the beginning of the “Open Call” have a higher chance of acceptance? Are ED slots allocated on a first come, first served basis?
A: All submissions received during the “Open Call” will be reviewed by the EDWP at the same time. There is no first come first served basis.
Q: What is the timeframe of an Early Dialogue, from the initiation of the advice to receiving an advice letter?
A: From the submission of the Draft Briefing Package by the Applicant to the final advice letter, the procedure takes 2.5 months for the Written-only format and 3.5 months for the F2F format. A face to face meeting 3 months after receipt of the Letter of Intent is organized with the Applicant, the HTA bodies, and (in case of a Parallel Consultation) EMA.
Q: Where will the Parallel Consultations and the Multi-HTA EDs take place?
A: Parallel Consultations requiring a F2F will take place on EMA premises in Amsterdam; Multi-HTA EDs requiring a F2F meeting will be hosted by either HAS in Paris, or G-BA in Berlin.
Q: Are EUnetHTA Early Dialogues free of charge?
A: Some HTA bodies may charge fees for their participation. The EUnetHTA ED Secretariat will provide detailed information on HTA associated fees after the request of the Applicant has been accepted as an Early Dialogue. Please include the financial contact in the EUnetHTA ED Request Form as requested.
For general information regarding possible fees the EUnetHTA ED Secretariat can be contacted in advance. The Applicant however can decide to accept the requested fees of the EUnetHTA partners in question or not (thereby not accepting the participation of the respective HTA bodies).
Q: Will I receive one advice letter for the ED or multiple ones?
A: All EUnetHTA EDs benefit from consolidated HTA recommendations; divergent opinions are included in the annex of the EUnetHTA Final Recommendations that are sent at the conclusion of each procedure.
Q: Is there any possibility for patient involvement in the process? How will this be facilitated: Is it under EUnetHTA’s remit or the Applicant’s responsibility?
A: EUnetHTA is committed to involving experts (patients and HCP) in its work – including EDs. Hearing directly from patients about the outcomes that matter to them and how their condition impacts their quality of life and hearing directly from HCP about natural disease history and current disease management are areas that are important from an HTA perspective.
EUnetHTA systematically endeavours to involve patients and patients’ representatives in all of its EDs. In order to best capture this input, EUnetHTA employs three approaches which are outlined in the table below.
EUnetHTA’s three approaches to Expert Involvement
Approach | Expert Deliverables |
|---|---|
Approach 1: Expert interviewed regarding the disease and their experience. | Minutes of the interview, Expert contribution visible in final, EUnetHTA recommendations, Feedback questionnaire and interview |
Approach 2: Approach 1 + discussion with local HTAb regarding submission file (without applicant). | Minutes of the interview, Expert contribution visible in final EUnetHTA recommendations, Feedback questionnaire and interview |
Approach 3: Approach 2 + discussion with all participating HTAbs regarding the submission file and participation in the F2F meeting with the applicant. | Minutes of the interview, Expert contribution visible in final EUnetHTA recommendations, Share final EUnetHTA recommendations, Feedback questionnaire and interview |
The selection of which approach to be used is the responsibility of the EUnetHTA ED Secretariat, who is also responsible for recruitment. This decision is based on multiple factors including: the identification of a patient and/or healthcare professional corresponding to a specific approach, Furthermore, it is possible that multiple approaches may be used in the same ED.
Q: How is the confidentiality managed taking into account all attendees/stakeholders of an Early Dialogue?
A: Full information regarding Confidentiality and Conflict of Interest is available in the guidance documents for Parallel Consultations and Multi-HTA Eds in the respective sections of the EUnetHTA website.
Practical Questions (e.g. templates, dates etc.)
Q: Are the Early Dialogues limited to one indication for the respective product, or could more than one indication for one product be included in one EUnetHTA Early Dialogue Request Form?
A: For the time being, the Early Dialogues are limited to only one indication per product/request. Some particular situations may however be taken into account such as e.g. the 1st line AND 2nd line of the same type of cancer etc. EUnetHTA would approach the Applicant for a final agreement in these constellations.
Q: Regarding the “area of advice” section of the EUnetHTA Early Dialogue Request Form, does the Applicant have to provide detailed questions at this early stage?
A: Detailed questions are not required at this early stage. It is appropriate to provide the scope of the questions in the Letter of Intent, and the detailed questions in the Briefing Document afterwards. Some examples for the scope of questions on clinical development are: study population, comparator, endpoints, study duration.
Q: Can the Applicant bring supporting information related to the selection/prioritisation criteria (new mechanism of action, targeting of a life-threatening or chronically debilitating disease, targeting of an unmet need)?
A: The Applicant is invited to briefly describe the mechanism of action, the indication, as well as why there is an unmet need in the “comments” box right underneath those questions in the EUnetHTA Early Dialogue Request Form.
Q: The EUnetHTA Early Dialogue Request Form includes a note stating, “No application will be accepted if the trial(s) for which you are requesting advice are currently on-going”. Could you please elaborate further on this statement?
A: The trials for which the Applicant is seeking advice must not be on-going at the time of the request. Moreover, the trial design should not be final at the time of the advice: e.g. it should be possible (but no obligation, Early Dialogues are not binding) to introduce changes to the studies planned following the advice. With regard to other ongoing studies, further information should be provided by the Applicant as well as including the potential consequences they might have in terms of e.g. possible changes in the Phase III studies, or in the target indication etc.
Q: Within the EUnetHTA Early Dialogue Request Form is the section “Other scientific advice or early dialogue (received or planned)” (screenshot) to be filled in by the Applicant or EUnetHTA?
A: This information is obligatory. EUnetHTA asks the Applicant to provide the information 1) whether an advice from regulators has been sought or not and 2) whether an Early Dialogue with HTA bodies already took place for this product either at national or EUnetHTA level.
Q: According to the Multi-HTA Early Dialogue procedure, the Applicant can propose the date for the Face to Face meeting. Will the final determination however be done by EUnetHTA?
A: The Applicant should propose the date keeping in mind the timeframe of the procedure and the timeline posted on the EUnetHTA website. The acceptance of the date will depend on availability of the requested date (i.e. if another ED is already scheduled at that time).
Q: Is there a maximum of participants on the Applicant’s side for the face to face meeting? Can observers form the Applicant’s side be included?
A: Although there is no set rule, a maximum of 10-12 persons should participate from the Applicant’s side. The number of participants would need to be confirmed and possibly adjusted once EUnetHTA is aware of the capacities of the meeting room at the respective meeting premises (EMA for a Parallel Consultation, HAS or G-BA in the case of a Multi-HTA ED). If the Applicant wishes to include observers this is possible. However, a maximum of 10-12 participants for the Applicant would still apply as specified above.
