OBJECTIVES : In July 2017, the European Network for Health Technology Assessment (EUnetHTA) and the European Medicines Agency (EMA) began offering manufacturers simultaneous, coordinated regulatory and payer/HTA advice. This research reviews the available early dialogue services in major European markets, providing an overview of payer/HTA advice and highlights the remaining challenges for companies seeking to incorporate early HTA input.

METHODS : Publically-available data on early dialogue services provided by regulatory, payer and HTA bodies in Europe were reviewed, comparing the costs, duration, processes and outputs.

RESULTS : The EMA and some European payer/HTA agencies have provided individual scientific advice since 2004. However, individual/national agency advice varies in duration (8-24+ weeks), processes (e.g., expertise used), price (~€2,000-€80,000) and outputs (e.g., report vs. meeting minutes). Stand-alone advice also requires separate company submissions. Parallel EMA/HTA advice was set up in 2011 to simplify the process of seeking pan-European advice requiring only a single document submission to all agencies. Despite the number of parallel advice projects steadily increasing since 2011, several areas of regulator and payer/HTA misalignment have been reported. The manufacturers were also left to consolidate individual agency reports. In a move to provide more coordinated advice, EUnetHTA Consolidated-Parallel-Consultation (EUnetHTA-CPC) builds on EMA/HTA parallel advice and provides a joint report of all agency positions, highlighting key differences. Despite joint advice output, the agencies nonetheless rely on different methodologies, often also reflecting variations in treatment pathways and/or comparator preferences.

CONCLUSIONS : Early advice options have improved significantly since 2011, with EUnetHTA-CPC procedure further supporting companies accessing the European market. However the challenges in reconciling differences in HTA methods and preferences remain. Furthermore, while EUnetHTA provides an overview of HTA opinions, it does not match the depth of advice provided by individual national advice, adding to the challenge of choosing the optimal early dialogue procedure(s).