A successful market access in Germany is highly significant for the introduction of innovative pharmaceuticals, even beyond the borders of the German market. As the largest pharmaceutical market in Europe, with a comparatively fast decision-making process, Germany often sets the standard for reimbursement rates in other countries. To achieve the desired reimbursement price, it is crucial to meet the Federal Joint Committee’s (G-BA) evidence requirements and obtain the highest possible additional benefit.

The G-BA offers consultations to help plan clinical trials and other aspects of benefit assessments, providing pharmaceutical manufacturers with critical information to optimize development plans to improve the market access potential. However, many market access professionals face challenges following these consultations due to uncertainties stemming from generic responses by the G-BA and remaining unanswered questions.

Why should you take advantage of G-BA consultations?

G-BA consultations are a sponsor’s only opportunity for direct interaction with the G-BA before the benefit assessment. Depending on the topics discussed, these consultations allow you to adjust your study design to meet national requirements, structure your benefit dossier’s arguments, or refine your overall market access strategy for Germany. There are two types of consultations: early consultations for clinical trial planning and consultations before submitting the benefit dossier, which can cover topics such as the appropriate comparator therapy (ACT), epidemiological aspects, or annual treatment costs.

In theory, the process is straightforward: First, you book a consultation appointment and submit a consultation request with the topics to be discussed for the benefit assessment. Your request is reviewed by the G-BA’s Subcommittee on Medicinal Products and, in the case of early consultations, by the national regulatory authority relevant to your indication — either the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul-Ehrlich Institute (PEI). Finally, the G-BA presents its position on the submitted questions in a consultation meeting, which is set-up as a discussion between participating parties.

In practice, however, there are many aspects to consider starting with the selection and wording of the submitted questions to allow for a reliable interpretation of the G-BA responses. Below, you will find practical solutions to help you precisely understand the G-BA’s requirements, avoid pitfalls, and make the most of the G-BA consultation for your successful market access in Germany.

Booking the appointment — Finding the right timing

The availability of consultation appointments is displayed on the G-BA’s website using a traffic light system. Green-marked appointments, which the G-BA readily accepts, are typically booked two to eight months in advance. Yellow-marked dates suggest checking whether another submission date might be possible. Red-marked dates are only available with proper justification, and it is explicitly noted that consultation requests for study planning should be submitted at another time. For early G-BA consultations, it is therefore essential to book the appointment sufficiently in advance or use the option to reserve a slot with the G-BA.

When choosing the date, consider that the assessment will be based on the documents submitted and the scientific-medical knowledge at the time of the consultation and is not legally binding. The earlier the consultation, the higher the likelihood that changes relevant to the benefit assessment, such as those concerning the ACT, could occur, potentially altering the G-BA’s position. However, you must also ensure you have enough time after the consultation to implement any changes to the study design or adjust the benefit dossier.

Submitting the consultation request — Choosing the right questions

A well-crafted consultation request is the key to a successful G-BA consultation. Typically, the request includes general information about the pharmaceutical company, the medicinal product or active ingredient, and the clinical studies relevant to the consultation, with emphasis on studies supporting approval.

If you are seeking an early G-BA consultation for study planning, you also need to submit the planned development program in summary form. Depending on the modality of the submission, you may also request the participation of the BfArM or PEI, which will facilitate an exchange with the G-BA on regulatory aspects relevant to the approval. After the consultation, the G-BA will give you the respective regulatory authority’s opinion, but representatives of these agencies typically do not attend the consultation meeting.

Beyond the formal section of the request, you provide the questions to be discussed at the consultation, including a clear outline of your position. To support your position, it is advisable to include sufficient background information (e.g., regarding the disease, classification, epidemiology, mechanism of action, study design, or regulatory aspects) to enable the G-BA to correctly interpret your position and corresponding questions.

Factors to consider when selecting questions

When preparing your questions, three aspects are key for a successful G-BA consultation:

1. Carefully weigh risks and opportunities of each question: The specific questions and positions presented should be carefully considered, as the consultation is documented, and the final minutes are included in Module 5 of the benefit dossier. While a blanket recommendation for or against certain questions is unhelpful, it is wise to assess whether there is any room for maneuver if the G-BA disagrees with your position. If you cannot influence critical aspects, it may be better not to raise them. However, only by asking questions can you clarify uncertainties before the benefit assessment and conduct an adequate cost-benefit analysis of potential study design changes or adjust the argumentation structure of the benefit dossier.

2. Focus on clear and precise questions with limited options for interpretation: Only clear, precise questions will result in interpretable and non-generic answers. Closed questions pose the risk (and opportunity) of a simple “yes” or “no” response. However, do not narrow the scope too much, as the G-BA will only respond to what is explicitly asked.
3. Ground your questions on scientific data: Your positions should be scientifically sound — this builds trust and allows you to test the argumentation structure for the benefit dossier before the actual assessment. Consider the different requirements for approval and benefit assessment, such as patient-relevant endpoints and the importance of the healthcare situation in Germany.

Potential questions

You must also decide which questions you want to raise during the G-BA consultation. Typically, questions regarding the ACT, study population, and planned endpoints are central, as these factors influence the benefit assessment and additional benefit rating. For example, you might ask whether the G-BA agrees that the comparators in your study represent the ACT in the relevant therapeutic area and whether the ACT is appropriately implemented in your study. Ideally, you should justify the comparators in your study using the four criteria outlined in Chapter 5, Section 6 of the G-BA’s rules of procedure (VerfO), considering Section 6 of the German Ordinance on the Benefit Assessment of Pharmaceuticals (AM-NutzenV). Other relevant topics may include questions about epidemiology or annual treatment costs. There is no upper limit on the number of questions, but the G-BA will not advise on all topics. For example, the G-BA does not provide advance assessments or evaluations of statistical aspects such as hypotheses, sample size planning, or statistical models.

Prepare for the G-BA’s assessment

Assemble your delegation

Your delegation should consist of up to ten people. Key roles include:

• Delegation leader: The main point of contact who coordinates the discussion with the G-BA.
• Clinical expert: Someone familiar with the indication.
• Interpreter: If global company representatives participate, as the consultation will be held in German.
• Medical writer: To document the consultation and ensure the implications for the benefit assessment are immediately clear and aligned with the G-BA’s minutes.

Ensure that all members of your delegation are familiar with the questions and your position. Prepare answers and follow-up questions, and assign responsibilities based on expertise. In complex cases, simulate the consultation meeting.

Consultation meeting — Transparency through dialogue

The consultation lasts around 60 minutes and is conducted via an online meeting. After introductions, G-BA representatives explain the legal framework of the consultation. The G-BA then presents its position on your questions based on a presentation.

The indication the G-BA uses to define its position is critical; it must align with your intended marketing authorization, as discrepancies can significantly impact the choice of ACT. When the G-BA divides an indication into subpopulations (“slicing”), you will need to demonstrate the added benefit for each subpopulation individually against the corresponding ACT.

You may ask follow-up questions, and brief discussions are possible. It is at the G-BA’s discretion to document these discussions in detail. Therefore, it may be useful to compare your internal protocol with the G-BA’s preliminary minutes to identify any discrepancies.

Follow-up — Deriving implications for benefit assessment

After the consultation, the G-BA will provide you with the statements from AkdÄ and the scientific-medical societies, as well as any feedback from BfArM or PEI, if applicable. You will also receive the research and evidence summary for ACT determination. The preliminary minutes are generally available within ten days but may take longer. You will have ten days to review them and propose changes, if necessary, with an option to request an extension.

During a follow-up meeting, you can clarify any uncertainties. It is your responsibility to track relevant developments in the indication and assess the implications for the benefit assessment. You may request additional consultations if needed. Identify gaps and discrepancies with the G-BA’s requirements and carefully interpret their language, as responses often allow for some interpretation.

Final takeaways

A G-BA consultation is the best opportunity for your pharmaceutical company to clarify critical questions related to the benefit assessment. This allows you to identify potential gaps in your line of argumentation or your scientific and initiate corrective action, specifically when engaging in the early G-BA assessment before the pivotal development program has been formalized. The right choice of questions, a well-written consultation request, and thorough preparation are essential steps to increasing your chances of a successful market access strategy in Germany.

Interested in learning more? Watch our recent webinar “Guide to Successful G-BA Consultations: Practical Tips for Market Access Professionals”:

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