On 30 June 2017 the EMA and EUnetHTA launched the new EMA/HTA parallel consultation platform. The new guidance replaces the former draft best practice guide as of publication date and has been developed from the experience gained with the SEED project, the best practice on EMA/HTA parallel advice pilot from 2010 and the subsequent public consultation. Roche has been involved in
EUnetHTA, a network of European HTA organization, established a new Secretariat and the Early Dialogue Working party (EDWP) to coordinate the involvement of the HTA bodies in the process phases. As of July 4, the EDWP is composed by the HTA bodies of 6 EU countries (FR, DE, IT, HU, UK and a shared membership between NL/BE).
From the HTA side, the new parallel consultation platform can take 2 pathways (both coordinated by EUnetHTA, involving regulators and following the same procedural steps, eg. same briefing package, F2F joint meeting, differing only differing only in how the outcome from the participating HTA agencies is presented). The EDWP is responsible for assigning each application to one of the 2 pathways below:
-
- “Consolidated Parallel Consultation” with consolidated HTA agency advice output: all HTAs members of the EDWP will participate + up to 3 additional HTAs (preferences expressed by the applicant will not always be accommodated). Applications falling under this pathway will receive a joint HTA outcome (in addition to the EMA/SAWP advice letter)
- “Individual Parallel Consultation” with individual HTA agencies providing final advice reports: EUnetHTA recruits the HTAs (preferences expressed by the applicant will not always be accommodated). The HTAs will send feedback to the applicant separately (in addition to the EMA/SAWP advice letter)
Only applications which meet all the criteria below may be allocated to the consolidated parallel consultation:
-
-
- Unmet medical need
- New mode of action
- Targeting life-threatening or chronically debilitating disease
-
Practical information for upcoming/planned meetings:
- The first scientific advice requests will be processed in September (Joint timetables)
- Applicants have to send a single letter of intent to the EMA and the EUnetHTA Secretariat simultaneously
- One unique briefing package, which includes a section on relative-effectiveness discussion, must be sent to EMA and EUnetHTA Secretariat 1 week earlier than the due submission date of the regulatory-only SA (at least 30 days prior to start of procedure). Requesting advice on economic assessments is optional. However, Roche strongly believes that the focus of European-level HTA agency collaboration activity (scientific advice and assessments) should focus on relative clinical efficacy assessments (REA) and that economic and other more context-specific HTA aspects should be dealt with at national level.
- The new process will follow a 70-Day procedure timetable automatically including a F2F meeting (no option for shortening to 40 day procedure)
- Of note, the EMA regulatory-only scientific advice and the multi-HTA dialogue tools still remain available to Marketing Authorization Holders
Expected benefits of the new platform
- Streamlined logistics (e.g. invitation of national agencies), written feedback from HTA agencies and increased exchange between EMA and HTA bodies (eg. one unique Letter of Intent, shared list of issues on the draft briefing package)
- Concrete commitment to involve patients and patient representatives in all TCs and the F2F meeting
- Optimal and robust evidence generation for different stakeholders: a single gateway for parallel advice on clinical features of development programs before the start of pivotal clinical trials (but for which there is still the time and possibility to inform/shape the design) to discuss initial evidence generation for MAA/Reimbursement and Post Licensing Evidence Generation (PLEG)