G-BA consultation: Preparation and early market access planning for Germany

Pharmaceutical companies can discuss questions on the appropriate comparator therapy (zweckmäßige Vergleichstherapie, zVT), study population and patient-relevant outcomes while changes to clinical development and evidence strategy are still feasible. A G-BA consultation is not an advance benefit assessment. It reflects the medical and scientific state of knowledge at the time of consultation and is not legally binding. Statistical aspects such as hypotheses, sample-size planning and statistical models are also not finally assessed in advance; their final assessment takes place during the benefit assessment based on the available data. The practical value of a G-BA consultation therefore depends not only on the G-BA’s answers. Timing, question selection, scientific justification of the company’s position and translation of the consultation outcome into development, evidence and AMNOG strategy are equally important. Regulatory status: October 2026. Available consultation dates, forms, timelines and other dynamic requirements should be checked against the current G-BA information for each consultation.

G-BA consultation at a glance

A G-BA consultation connects clinical development with the requirements of the later German benefit assessment. It is an upstream building block of the AMNOG process and prepares the evidence for the later AMNOG dossier.

A G-BA consultation is not an advance benefit assessment. The final assessment of clinical evidence takes place in the formal German benefit assessment procedure.

Plan market access for Germany early

Early market access planning links clinical development to the later requirements of the German benefit assessment.

The G-BA consultation becomes relevant where German questions need clarification before an important development decision is fixed.

Timing and process of a G-BA consultation

The timing of a G-BA consultation should be driven by when its outcome can still influence clinical development, evidence planning or AMNOG strategy.

Appointment booking → consultation request → G-BA review → consultation meeting → preliminary minutes → comments → final minutes → implementation

Timing the G-BA consultation within clinical development

An early G-BA consultation is particularly valuable while changes to the development programme remain possible. Questions on comparator choice, study population or outcomes should therefore be discussed before these elements are effectively fixed.

A later consultation can focus more strongly on dossier strategy or interpretation of the available evidence. Depending on the development programme, more than one consultation can be appropriate.

Book the G-BA consultation early

Consultation appointments should be reserved early. A planning window of approximately two to eight months between booking and the meeting may be required. Current availability should always be checked with the G-BA.

Submit the consultation request around ten weeks before the meeting

As a planning benchmark, the consultation request is submitted around ten weeks before the consultation date. By then, the questions, company position and scientific rationale should be sufficiently developed.

Plan for the G-BA minutes and follow-up

The consultation process does not end with the meeting. Documentation, review of the preliminary minutes and assessment of the final outcome need to be included in the project plan.

Prepare the G-BA consultation request

The consultation request defines which questions the G-BA assesses and the scientific basis on which the consultation takes place.

A robust consultation request combines:

1. precise questions,
2. scientifically justified positions,
3. strategic assessment of possible answers.

Formulate precise questions for the G-BA

Each consultation question should make clear which specific G-BA position is needed. The question should also be relevant to a concrete development or market access decision.

Provide a scientific rationale for each consultation question

Each consultation question should be linked to a transparent company position and scientific rationale. Regulatory development requirements and German benefit assessment requirements should be considered separately where they differ.

Develop response scenarios before the G-BA consultation

Possible answers and their consequences should be mapped before the meeting.

1. What position does the company take?
2. What G-BA response is expected?
3. What alternative response is realistic?
4. What would each response mean for development or market access?

The zVT as a topic in G-BA consultation

The appropriate comparator therapy, or zVT, is a central German market access question because it defines the comparator against which added benefit is assessed in the regular AMNOG framework. How the delineation of the zVT can play out in practice is shown by the analysis of donidalorsen and garadacimab.

Derive the zVT in the consultation request

A proposed zVT should be derived transparently from the relevant German criteria. These include authorised treatment options, reimbursable non-pharmacological treatments where relevant, existing G-BA decisions and the generally accepted state of medical knowledge.

Check implementation of the zVT in the study design

Market access planning needs to consider not only which zVT the G-BA identifies, but whether the clinical programme actually reflects that comparator.

Role of medical societies in determining the zVT

Scientific medical societies and the Drug Commission of the German Medical Association can contribute to the assessment of the treatment standard relevant to the zVT.

A zVT discussed in consultation can change

A zVT discussed during consultation is not permanently fixed. Changes in the standard of care, healthcare practice, authorised indication or patient subpopulations can require later reassessment.

Study population as a topic in G-BA consultation

The study population needs to be suitable not only for regulatory approval but also for the later German assessment question.

Align the study population with the planned indication

The rationale should consider inclusion and exclusion criteria, the planned indication, similarities and differences between study and target populations, clinical guidelines and relevant scientific literature. For the derivation of the German target population, see also real-world evidence in the AMNOG dossier.

Plan the regulatory population and German AMNOG population together

Study population → authorised indication → German patient groups → zVT → assessable evidence

Outcomes as a topic in G-BA consultation

Outcomes should be considered from a German benefit assessment perspective while their collection and operationalisation can still be influenced.

Clarify patient relevance of outcomes early

An outcome that is relevant to clinical development is not automatically usable in the same way for German benefit assessment.

Assess operationalisation and validity separately

The patient relevance of an outcome and the way it is defined, measured and analysed should be considered separately.

Other topics for G-BA consultation

Prepare the G-BA consultation meeting

A strong consultation request needs equally structured meeting preparation.

Build a multidisciplinary G-BA consultation team

The delegation should cover the expertise required for the submitted questions. A possible planning range is four to ten participants.

Assign responsibility for each G-BA consultation question

Simulate critical G-BA response scenarios

Simulation should cover more than the expected G-BA position. It should also test rejection, an alternative zVT, ambiguous answers and additional questions. The same logic applies to the later hearing in the AMNOG process.

How the G-BA consultation meeting works

Translate G-BA consultation outcomes into market access strategy

A G-BA consultation creates strategic value when its outcome is translated into concrete decisions for development, evidence planning and the AMNOG dossier.

Review documents after the G-BA consultation

Relevant documents can include statements from German authorities or medical societies, documentation supporting the zVT and the preliminary and final minutes.

Review the preliminary G-BA consultation minutes

1. Are the key statements documented correctly?
2. Is there relevant room for interpretation?
3. Are important points missing?
4. Are comments on the preliminary minutes required?

Derive consequences for evidence and AMNOG strategy

How evidence decisions later play out in the assessment is illustrated by the article on evidence transfer in Germany’s AMNOG assessment.

G-BA consultation under EU HTA

G-BA consultation retains a national role under EU HTA because German benefit assessment and pricing remain national processes. For context, see EU HTA in Germany and the JCA process.

G-BA consultation and Joint Scientific Consultation serve different purposes

European development advice is described in the guide to Joint Scientific Consultation.

Checklist for G-BA consultation

1. Is the consultation scheduled early enough for the outcome to be actionable?
2. Which market access decision should the consultation support?
3. Which questions genuinely need to be asked?
4. Is there a scientifically justified position for each question?
5. Are expected and alternative response scenarios defined?
6. Are zVT, study population and outcomes aligned with the current development programme?
7. Are roles and responsibilities for the meeting clear?
8. Is there a plan for translating the outcome into development, evidence and AMNOG strategy?