{"id":7236,"date":"2025-11-26T11:13:11","date_gmt":"2025-11-26T10:13:11","guid":{"rendered":"https:\/\/value-dossier.com\/?page_id=7236"},"modified":"2026-04-01T12:57:26","modified_gmt":"2026-04-01T10:57:26","slug":"dossiers-and-medical-writing","status":"publish","type":"page","link":"https:\/\/value-dossier.com\/en\/dossiers-and-medical-writing\/","title":{"rendered":"Dossiers and Medical Writing"},"content":{"rendered":"\n
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Dossiers and Medical Writing<\/h1>\n <\/div>\n <\/div>\n\n <\/div>\n
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Early Benefit Assessment of Medicinal Products (AMNOG)<\/h2>\n

The early benefit assessment under AMNOG (Section 35 of the German Social Code, Book V (SGB V)) begins with the market launch of a new medicinal product in Germany. The subsequent price negotiations (Section 130b SGB V) are crucial for the market success. The strategic and operational preparation of the dossier, as well as the price negotiations, must begin in advance of the actual market launch. As your experienced partner, we will guide you through the entire process. From G-BA consultation and dossier preparation to submitting comments and participating in hearings and negotiations on the reimbursement amount, you can rely on our expertise.<\/p>\n

Medical Writing<\/h2>\n

Benefit assessments entail the presentation of the medical benefits and added benefits of innovations compared to the relevant comparators or the appropriate comparator therapy. This applies to G-BA consultation preparation, AMNOG dossier compilation, and statement procedures.
\nA compelling value story is central to this process. It translates complex medical and scientific content into a clear, precise and strategic argument. This lays the foundation for a well-founded benefit assessment and a strong starting position in reimbursement and pricing negotiations.
\nIn collaboration with you, we will develop your value proposition and produce high-quality medical and scientific texts for dossiers, consultations and expert opinions. In this way, we help you to clearly articulate the benefits of your product and establish a solid foundation for communicating with health insurance funds and reimbursement bodies. Upon request, we can also create scientific publications tailored to your specific needs.<\/p>\n

AMNOG Modules 1\u20135<\/h2>\n

Together with you, we develop the strategy for your AMNOG benefit dossier. The G-BA consultation is generally a prerequisite for dossier preparation, so guidance on PICO (population, indication, comparator, outcomes) can be discussed in advance. Based on the clinical trial data, we implement the agreed-upon strategy and apply it in Modules 1\u20135, aligning with the G-BA\u2019s formal requirements:
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Figure 1: Overview of dossier modules<\/p>\n

We ensure that the dossier is submitted on time and to a high standard: at the time of marketing authorization for a new medicinal product or within four weeks of authorization for indication extensions. During the subsequent assessment process by the G-BA and IQWiG, we provide expert support to optimize the benefit assessment which is usually published three months after submission.
\nPlease do not hesitate to contact us directly for further details regarding the early benefit assessment process in Germany.<\/p>\n

Annex III<\/h2>\n

Annex III of the Medicines Guideline is an important regulatory reference point for pharmaceutical companies regarding reimbursement eligibility and prescribing within the statutory health insurance (SHI) system. It regulates prescribing restrictions and exclusions as well as the conditions under which medicines may be used within the SHI system. Therefore, it is crucial to consider regulatory requirements, medical justifications and strategic at an early stage.
\nWe will support you in thoroughly analyzing issues regarded to Annex III and presenting them in a manner that is both medically and scientifically robust. This includes analyzing the underlying evidence, presenting relevant arguments in a structured way, and developing a clear position for procedures, statements and communication with relevant stakeholders.<\/p>\n

EU HTA Dossier<\/h2>\n

The introduction of the EU HTA in 2025 under Regulation XY establishes a common European assessment process for new medicines. Initially, only oncological drugs and ATMPs (Advanced Therapeutic Medicinal Products) have been transferred to the European procedure, this will be followed by drugs for the treatment of rare diseases (orphan drugs) starting in 2028, with the remaining drugs completing the transition in 2030.<\/p>\n

The key difference from the AMNOG dossier is that the JCA (Joint Scientific Assessment) must include all PICOs or comparator therapies required by the member states. Due to varying national medical standards, a wide range of different PICOs may therefore be required. Since there are only a few months between the announcement of the PICOs by the relevant working group and the submission of the dossier, the JCA dossier must be planned and drafted in advance. Meeting the methodological requirements requires specialized knowledge.<\/p>\n