Client Challenge
Six years after initial approval, the German branch of the pharmaceutical company was surprised by an indication expansion for one of its drugs. The AMNOG-experienced team was informed of this at very short notice – the international colleagues were unaware that just four weeks after the European Commission’s confirmation of the indication expansion, a new benefit assessment by the G-BA (Federal Joint Committee) would be triggered. This typically necessitates the submission of a new dossier. This dossier now had to be compiled within approximately 40 days in cooperation with another external partner specialising in market access.
Kintiga Approach
Due to the expanded indications, a dossier already existed, prepared by a previous team, which we could use as a basis for our work. This dossier needed to be…
- with a value story developed quickly during the writing process and
- to revise based on the current state of research;
- to update to reflect the new population;
- to build upon the available evidence for the target population (whereby this evidence, i.e., Module 4 and Module 5, was developed by the other cooperation partner).
This required numerous short-term consultations and corresponding adjustments, as the usual strategic planning prior to the writing process was no longer possible. Kintiga Germany benefited from its experience with dossiers across a wide range of indications. Furthermore, due to the time constraints and the not yet fully developed strategy, our team, as strategy experts, was asked additional “what if…?” questions.
Solution
Despite the tight deadlines, the prompt start to the project, and the coordination of three partners involved (consisting of the client, an external dossier team, and the Kintiga Germany team), excellent collaboration, flexibility, and a convincing commitment resulted in the creation of a comprehensive dossier that served as the basis for a standardised benefit assessment.
