Wholistically handling HTA submission is a key competence of IGES with the experience of more than 150 submitted dossiers. The center of our efforts is to capture the value of your product adequately. By expressing its full potential in the respective HTA process, we make sure to create a solid foundation for meeting your price expectations.
We manage the interaction with authorities, compile necessary documents and information and tend to the actual submission of the assessment materials. IGES will also prepare written statements, train for or participate in oral hearings on your behalf, if required.
Fulfilling EU HTA obligations by providing full-service EU HTA dossier submission including PICO scoping, dossier document preparation, interaction with authorities, strategic alignment, post-hoc analyses and extensive procedural support.
In-depth analysis of clinical studies for HTA purposes according to PICO, while focussing on country-specific/European requirements. Identification of relevant gaps, derivation of mitigation strategies and optimisation of study planning and (post-hoc) analyses.
Early engagement with relevant HTA agencies via consultations helps to prepare for the complex HTA process, to define the appropriate comparator treatment and to navigate through the dossier submission process. Clinical studies, endpoints, relevant patient populations and further study-related issues are discussed with authorities at national/international level and advise is given to fulfil HTA obligations in a best possible manner.
The interplay between marketing authorisation, launch and HTA represents a complex procedure which can be optimized to fulfil HTA obligations in the best possible way, capture the value of a product and help successful pricing.
Fulfilling HTA obligations by providing full-service HTA dossier submission. The service includes dossier document preparation, information compilation, interaction with authorities, strategic alignment, post-hoc analyses and extensive procedural support including written statements and oral hearings in the AMNOG procedure. Trainings for oral hearing are offered.
Training of HTA hearing and negotiation teams to optimize HTA results. Extensive gap-analyses and scenario simulations to test the team’s performance under pressure and develop optimized strategies to best answer the questions of all involved stakeholders in the unique setting of HTA hearings.
Preparation and strategic support of price negotiations in respective countries. Development of pricing scenarios, models and innovative payment contracts with payors. If desired, participation in the negotiation meetings and on-site support. Existing collaboration with specialized and well-known law firm. Coordination with strategic implications for launch sequence.