Reimbursement decisions are a national/regional responsibility. When receiving recommendations from HTA bodies, national authorities apply national/regional policies, legal requirements and specificities relevant to the organisation of their healthcare systems.
However, current practices show that while there may be some differences in the methodology of HTA (for example the acceptability of some comparisons and comparators); the information needed to conduct relative effectiveness assessment is often quite similar across HTA bodies. It is also postulated that it may be useful for the sponsor of the technology to be aware of possible differences in evidence requirements from distinct HTA bodies.
EUnetHTA intends to develop Early Dialogues both for pharmaceuticals and medical devices. EDs are currently available for pharmaceuticals. EDs for medical devices may be launched in 2018, companies being interested in such EDs should contact the EUnetHTA ED secretariat (EUnetHTA-HAS@has.sante.fr)
Objectives of the EUnetHTA EDs:
- Support developers of medical technologies by providing a collaborative approach between a wide range of European HTA agencies to provide advice on their product development plans.
- Supply prospective and timely advice, before the start of pivotal clinical trials, in order to improve the quality and appropriateness of the data produced by the developers that may ultimately lead to well-informed regulatory and HTA and reimbursement decisions in a timely manner.
- Optimize the interaction with regulators for medicinal products, through parallel EMA-EUnetHTA multi-stakeholder EDs (Parallel consultations- Link to the page on PC to be added).
- Build upon the outcomes of the pilot EDs performed in the frame of EUnetHTA JA2 and the SEED (Shaping European Early Dialogues) project, reinforce structural organisation to facilitate the exchange of different perspectives, learning, efficiency, and consistency throughout EDs.
- Establish before the end of Joint Action 3 a financially sustainable structure for EDs, taking into consideration the need to make these EDs accessible for all companies, including SMEs/start-ups.
- Incorporate patient engagement in EDs on a regular basis.
- Link EDs to subsequent activities on additional data collection, including the use of patient registries.
The Early Dialogues Working Party (EDWP)
Regarding medicinal products, important experience has been gathered in the EUnetHTA JA2 and the SEED project. With a view to harness and build on this experience, EUnetHTA has established an Early Dialogues Working Party (EDWP). This robust and stable group of HTA bodies is constituted by HTA partners with a substantial experience in ED, high level of commitment and participation in JA3 EDs, and sufficient resources in terms of staff and level of expertise.
Currently, the EDWP is made up of five HTA bodies with a full seat: HAS (France), G-BA (Germany), NICE (UK), AIFA (Italy), NIPN (Hungary) and two HTA bodies, RIZIV-INAMI (Belgium) and ZIN (Netherlands) sharing a seat. In addition, for Italy, a model of having an alternate is being tested, with a regional HTA body (RER) substituting AIFA depending on availability.
In addition, for each ED, two HTA body representatives are appointed as Scientific Coordinator and Rapporteur in order to facilitate cooperation amongst participating HTA bodies, thus increasing the proportion and quality of common recommendations to the company.
The EDWP will be involved (with the participation of all its members), in all multi-HTA EDs and a selection of EMA-EUnetHTA Parallel Consultations.
HTA bodies that are not members of the EDWP may participate in some Early Dialogues as needed (on the basis of their availability and area of expertise). The HTA bodies participating in a given ED will constitute the EUnetHTA ED Committee for this ED.
This aims to ensure the constant quality of EDs while providing sufficient flexibility to allow for participation of additional HTA bodies from across Europe. This will allow the participation of agencies of various sizes in the process, while ensuring that all contributors have the necessary level of expertise and comply with the JA3 procedures.
EUnetHTA is committed to involving patients/patient representatives in its work – including EDs. Hearing directly from patients/patient representatives about the outcomes that matter to them and how their condition impacts their quality of life are two areas that are important from an HTA perspective. The procedure for how patients/patient representatives will be engaged to share their perspective is currently being developed and stakeholders, e.g. European patient organisations will be consulted during this process. EUnetHTA will look to learn from and build on the experience gained during SEED, within national HTA bodies procedures, and at the EMA.
The two types of EDs for pharmaceuticals
Prospective and timely advice may allow the sponsor to integrate specific HTA and regulatory needs into the development plan and therefore fulfill the evidence requirements of both regulators and HTA bodies. In this view, EUnetHTA, in cooperation with the EMA, proposes parallel EDs involving both HTA bodies and regulators.
EUnetHTA is offering two possibilities for EDs on pharmaceuticals:
- Multi-HTA EDs: HTA bodies only (no participation of regulators) ;
- EMA-EUnetHTA Parallel Consultations: in parallel between regulators (EMA) and HTA bodies.
Parallel consultation can be conducted with the participation of the EDWP (Consolidated Parallel Consultation, PCC) or with the voluntary participation of individual HTA bodies (Individual Parallel Consultation, PCI).
The choice between the HTA-only and parallel with EMA is up to the company.
For Parallel consultations, the choice between the two pathways(PCC or PCI) is made by the EDWP based on defined criteria.
The EUnetHTA ED Secretariat (EUnetHTA-HAS@has-sante.fr) is available for any additional information companies may need to take their decisions on the type of ED they should request.
General aspects and practical considerations
- EDs will remain confidential and are not 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.
- Letter of Intent: The request for benefiting of 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, available, together with the procedures and other relevant documents, on the corresponding sections of this website: Parallel Consultations (Link to the PC page) and Multi-HTA EDs(Link to the multi-HTA page).
- 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 are also available in the above mentioned sections of this website.
- Fees: Some HTA bodies may charge fees for their participation. The EUnetHTA ED Secretariat can provide information on HTA associated fees.
- Meeting venues: Parallel consultations meetings will take place at the EMA premises (London, UK). Multi-HTA ED meetings will take place either at HAS (Saint-Denis, France) or G-BA (Berlin, Germany).