The G-BA increases the fees for consultations

Manufacturers of drugs or medical devices can apply for a consultation meeting with the G-BA before submitting a dossier. This consultation offers a chance to get some feedback on questions regarding, e.g. the planned studies, the appropriate comparator, and key endpoints.

The key steps for the consultation process are:

1. Following the application, the G-BA will propose a date for the meeting.
2. Then, the manufacturer shares a briefing book outlining their product and trial plans. This briefing book also includes the questions to be answered by the G-BA alongside the manufacturer’s position.
3. In the consultation meeting, the G-BA will then discuss whether they agree or disagree with this position. The manufacturer is able to ask clarifying questions during the meeting.
4. Afterwards, meeting minutes will be shared which will form part of the dossier and therefore are publicly available.

The G-BA offers consultations for both types of assessments, early benefit assessments for drugs, as well as method assessments for medical devices, including high-risk medical devices.

These consultations are hugely valuable to the manufacturers and might help to avoid a resolution of “No additional benefit”. However, the G-BA charges a fee to cover their costs. In December 2021, these fees were raised. The fees are stated in the rules of procedure.

The fees vary depending on the types of questions to be discussed with the G-BA.

Consultations regarding early benefit assessments (§35a)

• General enquiries about the rules of procedure (German: “Verfahrensordnung”) or other enquiries with a comparable effort: €3,200
• Enquiries regarding the documents and studies to be submitted to evaluate the benefit of drugs, as well as how to compile the dossier or other enquiries with a comparable effort: €11,200
• Enquiries about the appropriate comparator therapy or other enquiries with a comparable effort: €16,000

An advance payment of €5,000 has to be paid when booking the consultation.

Consultations regarding assessments of medical methods and testing, including high-risk medical devices (§137e and §137h)

• General enquiries about
  • the formal prerequisites for submitting an application,
  • the prerequisites for reimbursement of a diagnostic or treatment method by the SHI funds
  • €825
• General enquiries about
  • procedural and methodological requirements for the evaluation of a diagnostic and treatment method,
  • the prerequisites and procedure of a testing study (“Erprobungsstudie”),
  • alternatives for financing the scientific monitoring and evaluation,
  • or other enquiries with a comparable effort
  • €3,300
• Enquiries with direct reference to a specific diagnostic and treatment method (or medical device) on
  • the prerequisites for reimbursement of the method by the SHI funds, including the separation of new services in statutory health care that are not seen as a new method,
  • procedural and methodological requirements for the evaluation of the diagnostic and treatment method,
  • the formal prerequisites for submitting an application,
  • the prerequisites and procedure of a testing study (“Erprobungsstudie”),
  • alternatives for financing the scientific monitoring and evaluation,
  • or other enquiries with a comparable effort
  • €11,550
• Enquiries about the procedural and methodological requirements for the evaluation of a specific diagnostic and treatment method or medical device, taking into account the applicable target population, the appropriate comparator therapy and the patient-relevant endpoints, including the requirements for a corresponding testing study or other enquiries with a comparable effort: €16,500

An advance payment of 50% of the full costs (or €3,000 for high-risk medical devices) has to be paid when booking the consultation.