Written comments and the G-BA oral hearing in the German AMNOG process

Written comments and the G-BA oral hearing allow outstanding assessment issues to be addressed after publication of the German benefit assessment and before the final G-BA resolution. For international market access teams, these steps are important because the published IQWiG or G-BA assessment is not yet the final decision on additional benefit.

The written commenting procedure provides a structured opportunity to respond to specific findings in the benefit assessment. The subsequent oral hearing allows remaining issues to be discussed directly with the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) and other participants in the commenting procedure.

The two stages have different functions. Written comments provide the documented scientific and methodological response. The oral hearing focuses on the questions that remain relevant for the final decision.

Benefit assessment → written comments → G-BA oral hearing → G-BA resolution

Preparation can start before the assessment is published. Potential evidence issues, additional analyses and foreseeable areas of criticism can already be identified during AMNOG dossier preparation. The published assessment then determines which issues actually require a response.

Regulatory status: October 2026. Timelines, templates and submission requirements should be checked against the current G-BA documentation for each procedure.

The hearing sits within the wider AMNOG process in Germany: the AMNOG dossier guide covers the evidence submission that precedes assessment, while the appropriate comparator therapy guide explains a central basis for the benefit assessment.

Written comments and the G-BA oral hearing at a glance

The commenting procedure starts after publication of the benefit assessment and precedes the G-BA's final decision on additional benefit.

Written comments are not a second AMNOG dossier. They respond to the specific findings of the published assessment.

The oral hearing is likewise not an oral repetition of the written submission. It provides an opportunity to clarify outstanding issues, add medical or methodological context and focus the discussion on points that may remain relevant for the G-BA resolution.

Written comments respond to the published benefit assessment

The written commenting procedure allows specific conclusions of the published benefit assessment to be addressed with evidence, analyses and scientific argumentation. The starting point is therefore not the complete original dossier but the issues raised by IQWiG or the G-BA.

Depending on the procedure, relevant topics may include:

• the appropriate comparator therapy (zVT),

• inclusion or exclusion of specific studies,

• new data cuts,

• additional statistical analyses,

• patient relevance and operationalisation of endpoints,

• interpretation of individual results,

• derivation of additional benefit,

• relevant patient populations,

• epidemiological estimates,

• annual treatment costs.

Written comments may correct a factual point, provide additional evidence or analyses, or explain why an assessment finding should be interpreted differently.

The response should remain closely linked to the published assessment. Repeating the complete AMNOG dossier would use the limited commenting period without focusing on the questions that have actually emerged from the assessment.

Formal requirements define the framework for written comments

Written comments are subject to a defined timeline, G-BA submission format and requirements for supporting literature. The submission deadline is three weeks after publication of the benefit assessment.

The G-BA provides a template that separates general and specific aspects. Scientific statements should be substantiated, and supporting literature must be provided in accordance with the applicable submission requirements.

The right to submit comments is not limited to the pharmaceutical company whose medicine is being assessed. Other organisations and experts defined under the procedure may also participate.

For pharmaceutical companies, this broader participation matters because medical societies, clinical experts and other commenting parties can add perspectives on the evidence, German clinical practice and the current treatment landscape.

General and specific aspects serve different functions

The distinction between general and specific aspects separates the overall clinical positioning from the detailed response to individual assessment findings.

General aspects may summarise the key results and position the medicine within the current treatment landscape, including findings on mortality, morbidity, health-related quality of life and adverse events.

This section should not reproduce the entire dossier. Its purpose is to establish the overall context and lead into the assessment issues that require a specific response.

Specific aspects address individual findings directly. These may concern the zVT, recognition of a study, additional analyses, new data, patient relevance of an endpoint or the assessment of the claimed additional benefit.

Overall context → specific assessment issue → evidence and argumentation

Not every assessment criticism should receive the same priority

An effective written response does not require every criticism to be addressed with the same level of detail. Priority should reflect the potential relevance of an issue for the subsequent assessment and G-BA resolution.

Prioritisation does not mean ignoring relevant criticism. It means concentrating evidence and argumentation on questions where further clarification can materially affect the assessment.

Preparation can start during AMNOG dossier development

The final written comments can only be drafted after publication of the benefit assessment, but potential assessment issues can be identified during dossier development.

Potential areas include:

• deviations from the expected zVT,

• study design limitations,

• uncertainty around patient-relevant endpoints,

• missing or problematic subgroups,

• limitations in transferability,

• missing data,

• statistical uncertainty.

An issue tracker or Q&A document can record foreseeable questions, available supporting evidence and analyses that could be performed if needed.

Potential updates can also be anticipated, including later data cuts, additional statistical analyses or updated epidemiological calculations.

Dossier development → potential assessment issues → benefit assessment → prioritisation → written comments

The published benefit assessment ultimately determines which prepared elements are actually needed.

Written comments and the oral hearing serve different functions

Written comments establish the documented scientific position; the oral hearing enables direct discussion of issues that remain open.

A complex methodological argument can be fully documented in writing and still become relevant again during the hearing. Conversely, the hearing should not be the first place where an argument that could have been clearly documented in writing is developed.

Written position → outstanding assessment question → oral discussion

The G-BA oral hearing enables direct scientific discussion

The oral hearing is the stage of the German AMNOG commenting procedure in which remaining assessment questions can be discussed directly. Participants include the G-BA and other parties involved in the commenting procedure.

Depending on the procedure, participants may include representatives of the G-BA constituent organisations, patient representatives, IQWiG, medical societies, clinical experts and other commenting parties.

Discussion may focus on the evidence, the relevant patient population and the medicine's position in the current treatment landscape. Medical societies can be particularly relevant where German clinical practice, treatment standards or the clinical relevance of specific findings require further context.

For the pharmaceutical company, the communication setting differs from the written response. The scientific position must remain consistent while allowing the team to respond to specific questions and the dynamics of the discussion.

The G-BA oral hearing follows a structured format

The hearing is formally moderated and typically consists of an opening statement, questions and discussion, and a concluding statement.

Opening → opening statement → questions and discussion → closing statement

The opening statement provides an opportunity to focus on a small number of central assessment issues and establish the key messages for the discussion.

The discussion then becomes the core of the hearing. Questions may cover different areas and may be directed to different participants. Medical societies may be asked to contextualise clinical practice, while methodological or evidence questions may relate directly to the dossier and benefit assessment.

A closing statement allows the pharmaceutical company to briefly restate the points it considers most relevant.

The hearing should therefore be prepared as a scientific discussion rather than as a presentation.

Key messages focus preparation for the G-BA hearing

The oral hearing should not attempt to reproduce the full AMNOG dossier or written comments. A limited number of clear key messages provides a reference point for the opening statement, answers and final summary.

Around four to five key messages can provide a practical framework. Depending on the procedure, they may relate to:

• the relevant patient population,

• the zVT,

• recognition of key evidence,

• patient-relevant endpoints,

• important statistical findings,

• derivation of additional benefit.

Each key message should be concise enough to remain clear under time pressure, while the underlying evidence is available for further explanation.

Focusing does not mean simplifying the evidence. It means reducing complex evidence to the statement that matters for the specific assessment question.

A structured Q&A prepares critical assessment questions

A Q&A links known criticism from the benefit assessment with potential follow-up questions during the hearing. The aim is not to predict every possible question but to prepare the main areas of scientific and methodological risk.

Relevant topics may include:

• study design limitations,

• the zVT,

• study population and subpopulations,

• endpoint operationalisation,

• patient relevance of endpoints,

• lack of statistical significance,

• disadvantages in safety outcomes,

• subgroup analyses,

• transferability to German clinical practice,

• derivation of the claimed additional benefit.

For each major issue, preparation should go beyond a preferred answer. Teams should also consider likely counterarguments, follow-up questions and the limits of the available evidence.

A useful Q&A therefore clarifies:

• What is the core position?

• Which evidence supports it?

• What alternative interpretation is plausible?

• What follow-up question may result?

• Who should answer it?

Roles and responsibilities should be defined before the hearing

Clear roles reduce contradictory answers and unnecessary coordination during the hearing. The team should know in advance who leads on each topic and who provides backup.

The team composition should reflect the expected assessment questions. Medical, statistical and market access responses should support the same overall scientific position.

Simulations test argumentation and responsiveness

Simulation exercises test whether the scientific argument remains consistent under time pressure, follow-up questions and an interactive discussion.

Scenarios can include:

• critical follow-up questions,

• repeated questioning of the same issue,

• complex or ambiguous questions,

• explicit doubt about an argument,

• rapid shifts between medical and methodological topics,

• unexpected detailed questions,

• speaker handovers.

Simulations can also reveal whether key messages are too complex or answers take too long.

The objective is not to script the entire hearing. It is to improve the team's ability to respond consistently across different discussion paths.

Critical questions should be contextualised rather than reflexively defended

Evidence limitations do not disappear when they are downplayed. The relevant task is to explain precisely what they mean for the assessment question.

Potential issues include study design limitations, endpoint uncertainty, lack of statistical significance, safety disadvantages, limited transferability or missing data.

A robust response first establishes what the limitation actually is. It can then explain why it arose, what it means for interpretation and what evidence remains available despite the limitation.

If a question is complex or ambiguous, clarification may be appropriate before giving a detailed answer. Teams should also avoid spontaneous commitments to provide additional data or analyses before feasibility has been assessed.

The oral hearing leads into the G-BA resolution

After the written commenting procedure and oral hearing, the G-BA adopts the final resolution on additional benefit. The published benefit assessment is therefore not the final stage of the German assessment.

AMNOG dossier → benefit assessment → written comments → oral hearing → G-BA resolution

Information submitted during the commenting procedure can feed into the further assessment. Depending on the evidence and methodological questions, additional assessment work may also occur.

The final G-BA resolution can therefore differ from the previously published benefit assessment. The G-BA decision on the magnitude and certainty of additional benefit for the relevant patient populations is decisive.

Preparing written comments and the oral hearing across the AMNOG process

Preparation connects knowledge from dossier development, analysis of the benefit assessment and focused scientific communication before the G-BA.

The same evidence issue may therefore appear at several stages: it may be identified during dossier development, criticised in the benefit assessment, addressed in writing and discussed again during the hearing.

Understand the evidence → analyse the assessment → prioritise relevant issues → document the response → focus the oral discussion

Frequently asked questions about written comments and the G-BA oral hearing

What is the deadline for written comments in the AMNOG process?

Written comments must be submitted within three weeks after publication of the benefit assessment.

Who can submit comments?

The pharmaceutical company concerned is not the only eligible party. Other organisations and experts defined under the German procedure may also submit comments.

What can be addressed in written comments?

Depending on the assessment, topics can include the zVT, studies, additional analyses, new data, patient-relevant endpoints, additional benefit, patient populations, epidemiology and annual treatment costs.

Can new data be submitted with written comments?

Depending on the specific situation, additional data and analyses may be relevant during the commenting procedure. Whether and how they can be considered must be assessed against the applicable procedural requirements and the specific assessment context.

Does every criticism in the benefit assessment need the same response?

No. Priority should reflect whether an issue can materially affect the assessment of additional benefit or other elements of the later G-BA resolution.

Who participates in the G-BA oral hearing?

Participants include the G-BA and parties involved in the commenting procedure. Depending on the procedure, this can include IQWiG, patient representatives, medical societies, clinical experts and pharmaceutical companies.

How should a G-BA oral hearing be prepared?

Preparation should include a small number of clear key messages, a structured Q&A covering critical assessment issues, defined responsibilities within the team and simulations of potential questions and discussion paths.

What is the role of written comments and the oral hearing in the G-BA resolution?

They form part of the procedure between publication of the benefit assessment and the final G-BA resolution. Evidence and scientific arguments introduced during this stage can inform the subsequent assessment and decision-making.

Who can support written comments and preparation for a G-BA oral hearing?

co.value supports pharmaceutical companies in analysing German benefit assessments, preparing written comments and preparing for G-BA oral hearings. Support can include prioritising assessment issues, addressing evidence and analysis questions, developing key messages and Q&A, and simulating the hearing.