Market Access with G-BA: Your Guide to Germany’s Leading Health Authority

The Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) is the highest decision-making body of the joint self-government of physicians, dentists, hospitals, and health insurance funds in Germany. Established in 2004, the G-BA is responsible for determining which medical services are covered by statutory health insurance (SHI), thereby directly influencing the healthcare provisions for over 70 million insured individuals. (g-ba.de)

Core Functions of the G-BA

The G-BA’s primary responsibilities include:

•     Benefit Assessment of Medicinal Products: Conducting benefit assessments of new pharmaceuticals to determine their added value over existing treatments.
•     Issuing Directives: Establishing legally binding guidelines for healthcare services, ensuring that SHI-insured individuals receive adequate, appropriate, and cost-effective care.
•     Quality Assurance: Implementing measures to maintain and improve the quality of healthcare services across Germany.

Leadership and Key Contacts

As of January 2025, the G-BA is chaired by Josef Hecken, who oversees the organization’s strategic initiatives and operations. 

The Subcommittee Pharmaceuticals (Unterausschuss Arzneimittel) plays a central role in benefit assessment for medicines. It is also chaired by Josef Hecken and vice-chair is Jörg Niemann.

Contact Details for the G-BA

Website: https://www.g-ba.de/english/

Address:
Federal Joint Committee (G-BA)
Gutenbergstraße 13
10587 Berlin, Germany

Challenges in Working with the G-BA

Engaging with the G-BA involves:

•     Understanding Regulatory Frameworks: Familiarity with the G-BA’s assessment criteria and submission requirements is crucial for successful market access. This includes relevant laws and the G-BA’s rules of procedure (Verfahrensordnung).
•     Timely and Accurate Submissions: Ensuring that all necessary documentation is complete and submitted promptly to facilitate the evaluation process. Benefit assessment (also called AMNOG) dossier are extensive documents requiring thorough preparation and significant lead time
•     Stakeholder Collaboration: Working effectively with various healthcare stakeholders in Germany to align with the G-BA’s guidelines and recommendations.

Successful collaboration with the G-BA can lead to efficient market entry and favorable reimbursement outcomes in Germany.

Opportunities / Solutions with Justin Stindt Consultants

Justin Stindt G-BA expertise ensures:

•     Expert Consultant G-BA Submissions: Creating high-quality submissions for benefit assessments according to G-BA’s rules of procedure (Verfahrensordnung).
•     Market Access G-BA Strategies: Proven methods for optimizing reimbursement outcomes.
•     Specialist G-BA Processes including written commentary procedure and hearings: In-depth knowledge of German healthcare regulations to accelerate approvals.

Expert G-BA Services

•     Expert G-BA Guidance: Our team provides direct support for market access and reimbursement challenges.
•     Expert G-BA Insights: We help you understand the latest evaluation criteria and submission processes.
•     Expert G-BA Documentation: Ensuring accurate and timely submissions that meet HTA expectations.

Justin Stindt Consultants specializes in helping clients prepare effective submissions and work successfully with G-BA evaluations.