Written statement and oral hearing revise the initial benefit assessment

Topic: Benefit assessment process according to §35a SGB V - oral hearing and written statement

Client: Pharmaceutical company


Our client was in the midst of the benefit assessment process according to §35 a SGB V (AMNOG procedure) when we were assigned to this this project. Previously, the dossier to a newly launched product was negatively evaluated by IQWIG, meaning is was assigned no additional benefit.

  • The next important milestone was the hearing procedure with an oral hearing at the G-BA.
  • The lack of experience put considerable psychological pressure on the oral hearing team.
  • Due to its extensive oral hearing experience such as its psychological-didactical skills SKC was appointed to train the pharmaceuticals company hearing team.

Solutions and approach

The oral hearing is a key milestone in the AMNOG process: at this point the basis for argumentation for the G-BA-decision can be improved significantly.

In this case our hearing and negotiation training took place as four coordinated workshops. The focus lay on the analysis of previously completed oral hearings for oncologics as well as the strategy development for the written statement procedure.

Preparation measures included:

  • the exegesis of the IQWiG-evaluation,
  • the analysis of precedent cases and the analysis of set precedents,
  • development of strategy and argumentation,
  • the realistic oral hearing simulation,
  • the integration of key opinion leaders.

Core of the workshop are several rounds of realistic oral hearing simulations in form and content. The experience gained from the simulation is used as a learning platform for future procedures.

Added value

It was possible to relativize the IQWiG-evaluation during the hearing: 

  • The G-BA decision and the main reasons extensively considered the value messages, which were developed and communicatively prepared with the client. 
  • A significant additional benefit was granted for the entire population.
  • The points of criticism of the individuals entitled to attend the hearing were anticipated and prepared for in advance, so that their positions were convincingly refuted on the basis of objective arguments.

The oral hearing team had internalized a consistent tactic and was perfectly aligned. The roles within the team were clearly defined according to the respective strengths and the oral hearing proceeded very smoothly.

The feedback from within the company and from the head of the G-BA was very positive.

to the top