Germany Adapts AMNOG Framework to Align with EU HTA Regulation for Medicinal Products
核心洞察
The German Federal Ministry of Health has passed the first amendment to the Medicinal Products Benefit Assessment Ordinance, integrating the EU Health Technology Assessment (搜索) (HTA) Regulation into Germany's AMNOG (搜索) procedure.
The EU HTA Regulation, effective January 12, 2025, introduces centralized Joint Clinical Assessments (JCA) for new medicines, initially covering cancer drugs and advanced therapy medicinal products, with orphan drugs following in 2028.
While the core AMNOG (搜索) process timeline remains unchanged, pharmaceutical companies now face new documentation requirements and must navigate parallel EU and national assessment procedures.
The German Federal Ministry of Health has taken its first step toward integrating the European Union's Health Technology Assessment (搜索) (HTA) Regulation into Germany's established AMNOG (搜索) framework for drug benefit assessment. On March 4, 2025, the Ministry passed the First Ordinance amending the German Medicinal Products Benefit Assessment Ordinance (AMNutzenV), addressing the interaction between Germany's national procedures and the new EU-level Joint Clinical Assessments (JCA).
EU HTA Regulation Creates New Assessment Landscape
The EU HTA Regulation (EU) 2021/2282, which officially entered into force on January 12, 2025, represents a significant shift in how new medicines are evaluated across Europe. The regulation introduces centralized Joint Clinical Assessments at the EU level, aiming to reduce duplicative efforts across member states while maintaining consistent evaluation standards.
"The goal is to reduce multiplying efforts for HTA in each member state by introducing a centralized procedure on EU level," explains the Ministry in its documentation of the changes.
Initially, the JCA process will apply to cancer drugs and advanced therapy medicinal products (ATMPs) submitted through the centralized marketing authorization procedure. Orphan drugs will be included starting in 2028, with all centrally authorized medicinal products covered by 2030.
Key Elements of Germany's AMNOG Process Preserved
The amendment maintains the fundamental structure of Germany's AMNOG (搜索) process, which has been in place since 2011. Under this system, pharmaceutical companies must still submit a benefit dossier to the Federal Joint Committee (搜索) (G-BA (搜索)) upon launching a product with a new active ingredient in Germany.
The Institute for Quality and Efficiency in Health Care (搜索) (IQWiG (搜索)) typically conducts the assessment within three months, followed by the G-BA (搜索)'s evaluation and benefit rating within another three months. Based on this rating, companies negotiate reimbursement prices with the Federal Association of Sick Funds (搜索) (GKV-Spitzenverband (搜索)).
Importantly, the amendment preserves the timeline of the AMNOG (搜索) process, which is usually completed within one year after product launch. The negotiated reimbursement price continues to apply retrospectively from the beginning of the seventh month after initial launch.
Navigating Parallel EU and National Assessments
A key challenge addressed by the amendment is how pharmaceutical companies should handle information already submitted at the EU level. The ordinance now requires companies to indicate in their German dossier "whether and which evidence" from the European dossier forms the basis for the German benefit assessment.
This gives companies two options: either launch immediately after marketing authorization and accept potential duplicate work, or wait until the final JCA report is published before entering the German market.
Dr. Matthias Wilken, healthcare policy expert at the Association of Research-Based Pharmaceutical Companies (vfa), commented: "Companies now face strategic decisions about market entry timing. The amendment offers flexibility but also creates uncertainty about how the two processes will interact in practice."
New Disclosure Requirements
The amendment also introduces additional disclosure requirements. When evidence from a European dossier serves as the basis for a German benefit assessment, the G-BA (搜索) must provide a link to the EU HTA IT Platform where that dossier is published.
If the European dossier is not yet published at the time of the G-BA (搜索)'s assessment, pharmaceutical companies must submit a version of the European dossier—containing at least the evidence used in the German assessment—within three working days. This will be published on the G-BA website until the official version becomes available on the EU platform.
Unresolved Questions Remain
Several aspects of the integration remain unclear, particularly the meaning of "due consideration" that member states must give to JCA reports. The amendment does not clarify this term, acknowledging that it needs to be substantiated at the EU level first.
The Ministry notes that "learning processes will occur both at the EU level and in the interaction between EU HTA and national procedures" during the initial implementation phase. It has committed to monitoring developments and making further adjustments if necessary.
Another unresolved issue involves potential conflicts between the English and German versions of the HTA Regulation regarding restrictions on duplicate submissions. The English version appears stricter in prohibiting companies from submitting information already provided at the EU level.
Next Steps for Implementation
Following these amendments to the Medicinal Products Benefit Assessment Ordinance, the G-BA (搜索) will need to update its Procedural Code, which will likely provide more detailed guidance on implementing the HTA Regulation in Germany.
Industry observers note that while the HTA Regulation represents a significant step toward harmonizing health technology assessment (搜索) across Europe, the minimal implementation approach taken by Germany reflects caution about disrupting its established and well-functioning AMNOG (搜索) process.
Pharmaceutical companies operating in Germany are advised to carefully reconsider their market access strategies to ensure compliance at both EU and national levels while navigating this evolving regulatory landscape.