Strategic HTA Consultation

Glogger Consulting provides comprehensive strategic support across all phases of the HTA impacted phases from early clinical development to price negotiation and life cycle management. This is focused on German AMNOG and EU HTA processes including identification of potential challenges and development of solution-oriented strategies.
Clients benefit from guidance, strategic sparring to ensure thorough preparation as well as mock negotiations / hearings for authorities:

Pipeline HTA: input on study design (PICO) planning of phase II / III studies to ensure sustainable reimbursement early on and in-depth assessments of success probabilities for HTA outcomes

German AMNOG (§35a SGB V): In-depth assessments of success probabilities for HTA outcomes (AMNOG) with G-BA/IQWiG and pricing expectations - including mitigation strategies. Early advice with G-BA, dossier strategy development, responses to IQWiG/G-BA benefit assessments, oral hearing preparation, stakeholder mapping and engagement, value communication, and Real-World Evidence generation

EU-HTA: guidance & how to navigate, JCA dossier strategy development, JSC early advice, stakeholder mapping

Example cases:

„We have a single arm phase III trial and identified a historical control group- can we achieve additional benefit during AMNOG and what does this mean in terms of pricing and access?“