General Questions (e.g. pathways, fees etc.):
Q: In case of a request for a Parallel Consultation, will products that were not selected for the consolidated pathway (Consolidated Parallel Consultation, PCC) automatically enter the individual pathway (Individual Parallel Consultation, PCI)?
A: Yes, they will. The determination of the pathway for Parallel Consultations will depend on the evaluation of the selection criteria by the EDWP for the specific request. The Applicant will be informed by the EUnetHTA ED Secretariat about the EDWP decision. The Applicant can decide to continue in the pathway determined by the EDWP or could otherwise withdraw the request.
Q: Is the possibility foreseen that Applicants seeking for a consolidated or an individual procedure (PCC/PCI) might be completely rejected?
A: No, but in the individual pathway (Individual Parallel Consultation, PCI) HTA bodies participate on a voluntary basis, therefore in theory, if no HTA body expresses its interest to participate the request may not be satisfied.
Q: For the option of a Multi-HTA Early Dialogue (without the EMA), is EMA going to be observer?
A: EMA is invited to observe all non-parallel Early Dialogues – however, as observers they will not actively participate in the ED should they choose to attend. The choice between an HTA-only approach or a Parallel Consultation with EMA is up to the Applicant.
Q: How will EUnetHTA facilitate the participation of the HTA bodies requested by the Applicant?
A: The Applicant does not have to contact the HTA bodies directly as it was the case for the former Parallel Scientific Advice (PSA) procedure for parallel consultations with EMA and HTA bodies. The EUnetHTA ED Secretariat will facilitate the recruitment in a centralized manner. Please note that participation of the requested HTA bodies by the Applicant cannot be guaranteed. However, EUnetHTA aims to facilitate HTA body participation for the Applicant in a satisfying manner. EDWP involvement for Parallel Consultations will depend on the determined pathway (PCC/PCI) for the request according to the selection criteria. In case of an Individual Parallel Consultation (PCI) HTA bodies participate on a voluntary basis. All Multi-HTA EDs involve the EDWP if the request will be accepted by the EDWP.
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 Letter of Intent by the Applicant to the final advice letter, the procedure takes 135 days (4.5 months). A face to face meeting 4 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, both PCI and PCC will take place on EMA premises in London. The Multi-HTA EDs will be hosted by either HAS in Paris, or G-BA in Berlin.
Q: Are the Early Dialogues free of charge?
A: Some HTA bodies may charge fees for their participation; however for now most do not. 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 Letter of Intent 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: How will this hybrid financing (some HTA bodies will be financed by EUnetHTA while others will receive fees) be facilitated by EUnetHTA?
A: Hybrid financing was introduced to facilitate the involvement of HTA bodies requesting fees in order to make the best use of the EUnetHTA Joint Action 3 budget. 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. The Applicant is under no obligation to include those EUnetHTA partners requesting fees for participation. However, the EUnetHTA ED Secretariat needs to know the decision of the Applicant on this matter as rapidly as possible. Should the Applicant decide to pay fees, the EUnetHTA ED Secretariat will put them in direct contact with the EUnetHTA partners in question in order to provide all the information necessary for the Applicant and facilitate the payment etc. Please note that even if fees are paid, there will not be a separate final advice letter for Early Dialogues with EDWP involvement (i.e. multi-HTA or PCC). Instead, all of the common positions but also national specific positions will be integrated into the global EUnetHTA Final Recommendations.
Q: Will I receive one advice letter for the ED or multiple ones?
A: This depends on whether you participate in a PCC/Multi-HTA or a PCI. For PCC/Multi-HTA there will be a single EUnetHTA advice letter containing sections with common positions, as well as national-specific positions of participating HTABs. If your product follows the PCI pathway, you will receive individual advice from each participating HTAB. These individual recommendations will generally be transmitted to you by the ED Secretariat.
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: Patient involvement/recruitment will be facilitated by EUnetHTA. The Applicant will be asked to indicate whether the Briefing Book can be shared with patients. As a matter of course, participating patients are required to complete the same declaration of conflict of interest and confidentiality clause as all participating EUnetHTA partners.
Q: How is the confidentiality managed taking into account all attendees/stakeholders of an Early Dialogue?
A: Each person participating in a EUnetHTA Early Dialogue (including patients or external experts) is required to sign the EUnetHTA Declaration of Interest and Confidentiality Undertaking (DOICU) form prior to receiving any information submitted by the Applicant. An update it requested at minimum annually. The DOICU form and the procedure to handle these declarations are available on this site (Please add LINK)
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 Letter of Intent?
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 Letter of Intent, 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 letter of intent.
Q: The Letter of Intent 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 Letter of Intent template 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 has to be provided by the Applicant. 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 10-15 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 10-15 participants for the Applicant would still apply as specified above.