A one stop shop for joint advice between EMA, EUnetHTA and health technology assessment bodies – The new parallel consultation process
There has been a significant increase in manufacturer seeking early regulatory, payer and HTA input into their clinical development programs since the implementation of the EMA parallel scientific advice process in 2010. The announcement in July 2017 by EMA and EUnetHTA to collaborate and implement a joint process should facilitate manufacturer’s desires to develop robust evidence that satisfies the needs of both regulators and HTA bodies.
The new “parallel consultation” process aims to provide a single gateway, allowing more streamlined process with both regulatory and HTA bodies. Under the new process, manufacturers must now only notify EMA and EUnetHTA simultaneously of their intention to request parallel advice. Following this EUnetHTA’s Early Dialogue Secretariat will coordinate the involvement of the HTA bodies that will take part in the advice. This is a significant simplification and replaces the existing tool EMA-parallel scientific advice, in which manufacturers were required to contact the HTA bodies from each individual member states they were seeking advice from.
Other changes include the incorporation of patient representatives in parallel consultations on a routine basis so that their views and experiences can be incorporated into the discussions. The scope of the consultation has also been broadened to include post-authorisation data collection, as well as during clinical development. The timelines for the parallel consultation are expected to be comparable to the EMA’s previous parallel scientific advice, typically taking between 4-6 months. Fees for the process are the same as the regulatory scientific advice process, ranging from €42,000 – 84,000.
The “parallel consultation” process is expected to have numerous benefits including:
- Increase the understanding and problem-solving abilities amongst manufacturers due to a more structured interaction between EMA and HTA bodies
- Improve the coordination with, and increase participation of HTA bodies, as well as streamlined logistics for the manufacturer
- Closure of the gaps between evidence requirements of regulators and HTA bodies to enable the development plan to address the needs for both parties
- Streamline the manufacturer’s clinical development program by aiming to allow them to produce just one data set
- Determine the post launch evidence generation program to enable continuous risk-benefit and long-term effect assessment of the medicine
- Support opportunities for mutual understanding and problem solving between Regulators and HTAs
Whether the new parallel consultation process will deliver on all the benefits, remains to be see. However, most manufacturers will welcome the simplification of the approach and the central point of contact for seeking HTA and regulatory input. These changes are likely to further drive manufacturers to seek early payer input, in order to optimise their clinical development program and gain enhanced patient access.