Client Challenge
The client faced an unclear approval landscape, which led to delays in decision-making around market access activities. At the same time, they were preparing to extend the indication, with approximately three months remaining to finalize the benefit dossier. To support this timeline, we facilitated a strategic workshop and provided guidance for a short-term consultancy application, ensuring alignment across stakeholders and accelerating next steps.
Kintiga Approach
As part of the dossier strategy, a precise definition of strategic and operational must-haves was jointly developed with the client to ensure submission of a complete dossier. The focus was placed on clearly articulating the product’s core value propositions—both in terms of content and formal precision.
· Detailed analysis of reproducible and newly required dossier elements from the initial indication
· Reduction of formal content without strategic value, in line with permissible AMNOG requirements
· Selection and limitation to core content within the supportive study presentation, while planning and executing targeted post-hoc analyses to strategically reinforce the product’s key value messages
· Singular, focused question for the G-BA consultation meeting, aimed at sharpening the dossier’s core strategy
· Technology-supported dossier development, including the use of our semi-automated data transfer approach and AI-based Endpoint Result Interpreter (EPRI) tool for accurate description and interpretation of clinical data within the dossier
Solutions
Supported by the use of EPRI—our cutting-edge managed AI writing service designed to streamline the creation of tailored, high-quality German AMNOG, UK NICE and EU Joint Clinical Assessment (JCA) dossiers. A complete benefit dossier was successfully developed within just three months, a fraction of the usual timeframe.
With EPRI (EndPoint Result Interpreter) we power our managed AI writing service for high-quality German AMNOG, UK NICE and EU Joint Clinical Assessment (JCA) dossiers. Our Health Technology Assessment (HTA) experts combine our proprietary AI with scientific rigour to deliver ready-to-submit dossier components – so you get the speed of AI and the experience of our senior team, without the burden of implementation or training. The result: managed complexity, dramatically reduced timelines and the highest standards of accuracy and reliability.
EPRI Interpretive Writing Service is a managed, AI writing service that acts as an extension of your dossier writing team. Using our inhouse-developed EndPoint Result Interpreter (EPRI), our HTA expert team accelerates the generation of HTA dossier components by transforming complex clinical data into clear, accurate descriptions—reducing throughput time while maintaining scientific rigour.
Our innovative technology helps to manage complexity, reduce time and costs and ensure the highest standards of accuracy and reliability. The efficiency gains in dossier preparation also enabled the preceding G-BA consultation to take place.
A consistently agile working approach, short-notice and flexible coordination among all team members, and a strong focus on content—combined with additional consulting services—led to a successful project outcome. Despite the very late project start, the legally mandated latest submission date for the AMNOG benefit dossier (four weeks post-approval) was not only met but even undercut by several days. This helped avoid a significantly negative impact of a strategically weak dossier on the hearing and price negotiation process.
Interested to learn more about EPRI? Visit the EPRI page or contact us now at enquiries@kintiga.com.
Glossary of terms:
- AI – Artificial Intelligence
- AMNOG – Arzneimittelmarktneuordnungsgesetz (German Pharmaceutical Market Restructuring Act)
- HTA – Health Technology Assessment
- EPRI – Endpoint Result Interpreter
- G-BA – Gemeinsamer Bundesausschuss (Federal Joint Committee)
