NICE has for, a number of years (and currently continues to), provided scientific advice and HTA early dialogue to manufacturers through the EMA HTA parallel consultation process (in partnership with the EMA and other HTA bodies). However, with the UKs upcoming withdrawal from the European Union, NICE’s relationship with EMA and indeed, the parallel scientific advice process is uncertain.
As it is unlikely that NICE will continue to offer scientific advice as part of the parallel scientific advice procedure, one option for manufacturers is to utilize NICE’s European HTA and regulatory concurrent advice service.
The concurrent scientific advice process works alongside EMA timelines and requires submission of the same briefing book provided to the EMA. Both NICE and the EMA will assess the briefing book separately and the company will receive two separate list of issues from each stakeholder, respectively.
NICE then offers manufacturers two options:
- Option 1: a face-to-face meeting with NICE that coincides with the EMA meeting
- Option 2: a face-to-face meeting taking place after receipt of the EMA meeting and advice report.
The majority of manufacturers undertaking this process appear to prefer Option 2, which enables greater time to digest the EMA advice prior to the NICE meeting.
It should be noted that whilst the offering is expected to be particularly used post-Brexit, it is already available for manufacturers who have:
- Requested regulatory advice from the EMA and would like to request NICE advice at the same time
- Requested European parallel scientific advice and been rejected.
Another key Brexit consideration is the potentially reduced role of the EMA in market authorization for pharmaceutical products launching in the UK. As such, NICE have also launched a concurrent scientific advice procedure with the MHRA. In the current situation, uptake of this offering is likely to be low, however it does have the potential to increase in the post-Brexit era.
Overall, these offerings demonstrate NICE’s awareness of the likely changes and preparation for providing scientific advice once the UK has left the European Union. For companies which view UK as a key market for access, it will become important to begin considering seeking concurrent NICE scientific advice, alongside the parallel EMA scientific advice procedure.