Client Challenge
At the time the project was commissioned, our client was already in the midst of the benefit assessment process according to Section 35a of the German Social Code, Book V (AMNOG procedure). Previously, the dossier for their newly launched product had been assessed negatively by the Institute for Quality and Efficiency in Health Care (IQWiG), meaning it had no added benefit. The next important milestone was the consultation process with a hearing before the Federal Joint Committee.
Lack of experience created considerable psychological pressure within the hearing team. Kintiga Germany was commissioned to train the hearing team due to its extensive hearing experience and psychological-didactic expertise.
Kintiga Approach
The oral hearing is an important milestone in the AMNOG process: at this stage, the basis for argumentation in favour of the G-BA decision can be significantly improved. In this case, our hearing and negotiation training took place in four coordinated workshops .
The focus was on evaluating previously completed hearings on oncology drugs and developing a strategy for the consultation process.
The preparation was carried out, among other things, by:
- the exegesis of the IQWiG assessment,
- the analysis of precedents,
- the development of strategy and argumentation,
- the realistic hearing simulations,
- the involvement of key opinion leaders.
The workshops centred on formally and substantively realistic hearing simulations . The experiences gained in the simulation were compiled for the company as a learning platform for future procedures.
Solutions
The hearing allowed the IQWiG assessment to be put into perspective.
- The G-BA decision and the supporting reasons fully took into account the value messages that were developed and prepared for communication with the client.
- A substantial additional benefit was determined for the entire population.
- The criticisms of the individual parties entitled to be heard were anticipated and prepared in advance, so that their positions could be convincingly refuted on the basis of factual arguments.
The hearing team had internalised a consistent strategy and was optimally coordinated. Within the team, roles were clearly distributed according to individual strengths, and the hearing proceeded smoothly.
The feedback within our own company was very positive .
Glossary of terms:
- AI – Artificial Intelligence
- AMNOG – Arzneimittelmarktneuordnungsgesetz (German Pharmaceutical Market Restructuring Act)
- HTA – Health Technology Assessment
- G-BA – Gemeinsamer Bundesausschuss (Federal Joint Committee)
