This presentation details the role of European HTA bodies in the value of new cancer therapies in Europe. The presentation also describes the NICE scientific advice activities and the activities of the HTA / regulatory parallel advice.
EMA-EUnetHTA Parallel Consultation (New July 2017)
The main benefits of the parallel consultation procedure include:
streamlined procedure for applicants;
increased mutual understanding and problem-solving ability between EMA and HTA bodies through a more structured interaction;
improved coordination with, and greater participation of HTA bodies in parallel consultations through EUnetHTA’s Early Dialogue Working Party (EDWP) and the EUnetHTA Early Dialogue (ED) Secretariat.
Patients/Patient representatives and healthcare professionals also participate in the parallel consultation procedure on a routine basis
May be some fees
NICE Scientific Advice
Advice for HTA and trial evidence generation plans, regulatory advice (EMA, MHRA), EMA-EUnetHTA Parallel Consultation, model evaluation (PRIMA)