Consultations with the G-BA

The G-BA offers multiple chances for consultation before submitting a dossier.

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, the G-BA will share the meeting minutes with the manufacturer.
5. When the manufacturer submits the dossier, they have to indicate whether the G-BA was consulted regarding the ACT. In that case, they can attach the minutes of the consultation.

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.

As of 9 Dec 2021, the fees for these consultations are as follows:

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

Companies have to pay an advance payment of €5,000 when booking the consultation.

Consultations regarding assessments of medical methods and testing (§137e); = assessment of medical devices

• 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

Companies have to pay an advance payment of 50% of the full costs when booking the consultation.

Consultations regarding assessments of medical methods using high-risk medical devices (§137h)

• General enquiries about
  • the formal requirements for the obligation to provide information,
  • the prerequisites for reimbursement of a diagnostic and treatment method using a high-risk medical device by the SHI funds
  • €825
• General enquiries about
  • the prerequisites and procedure of for the evaluation of a diagnostic and treatment method using a high-risk medical device
  • the procedure of a testing study (“Erprobungsstudie”),
  • alternatives for financing the scientific monitoring and evaluation of the testing study,
  • or other enquiries with a comparable effort
  • €3,300
• Enquiries with direct reference to a specific diagnostic and treatment method (or medical device) on
  • procedural and methodological requirements for the evaluation of the diagnostic and treatment method using a high-risk medical device,
  • the prerequisites and procedure for financing the testing study,
  • 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 using a high-risk 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

Companies have to pay an advance payment of €3,000 when booking the consultation.