AMNOG Benefit Assessment
The successful placement of your product on the market is significantly influenced by a professional execution of all components of the early benefit assessment according to AMNOG. Demonstrating the additional benefit of your medication compared to the standard therapy requires navigating a complex landscape involving IQWiG, G-BA, and the National Association of Statutory Health Insurance Funds (GKV-SV).
Since pioneering in 2010, AMS has become one of the market leaders in the AMNOG benefit assessment, with over 300 dossier projects across more than over 50 indications. Our interdisciplinary team of medical writers, statisticians, and project managers professionally guides you through the entire benefit assessment process. In addition to AMNOG benefit assessments, we are also happy to support you in the area of EU HTA.
With the introduction of EU HTA, the scope of information required for AMNOG submissions is evolving. The data submitted as part of the AMNOG procedure must align with what has already been presented at the EU level. The so-called “Delta Dossiers” must not duplicate data previously submitted in the EU Joint Clinical Assessment. An optimal benefit assessment now requires the integration of JCA data into the AMNOG framework. We prepare the AMNOG Delta Dossier ensuring seamless alignment with the JCA process and close collaboration with the respective teams.
Mike Dieser
Associate Director Medical Science
Mike has more than 30 years of experience in project management, business organization and account management in various industries. His academic background includes studies in medical informatics as well as business administration and law.
Mike has been working at AMS since 2013, where he is responsible for account management and business organization with a focus on the entire AMNOG process. Initially, he headed the Medical Science project management division from 2013 to 2017 before focusing entirely on account management, business development and contract management. He is particularly keen to maintain close and trusting relationships with both long-standing and new customers.
Mike has been an Associate Director Medical Science since 2017 and also took on the role of one of three authorized signatories in 2023. In addition to his main role at AMS, he completed training to become an MHFA first responder in 2023, enabling him to also get involved in the field of mental health.
Mike is happy to answer any questions you may have about the AMNOG process.
Your service expert
Mike Dieser
Associate Director Medical Science
Our services include
(Early) G-BA Consultation
A successful HTA process begins with early study planning that integrates HTA considerations and a focused PICO strategy – selecting the appropriate comparative therapy and patient relevant outcomes measures. Benefit from targeted support during the (early) G-BA consultation to ensure your evidence strategy is aligned early and effectively with HTA requirements.
Market Access Consulting
In close collaboration with you, we develop a targeted value story and a coordinated evidence and pricing strategy.
Epidemiology & derivation of patient numbers
Accurately determining and presenting patient numbers is essential for reliable market analysis and sound strategic decisions. With our expertise, you gain a science-based, market-focused analysis that supports your strategy with confidence.
Statistical Analyses and Consulting
Comparative evidence is often the key to a successful benefit assessment. To meet HTA requirements effectively, it is crucial to consider the specific methodological criteria at an early stage.
Written Statement
The Written Statement is a critical step in strategically addressing the benefit assessment and reinforcing your evidence base. Together, we identify evidence gaps, develop a targeted line of argument, and ensure that your position is communicated clearly and convincingly.
Training and Preparation for the Oral Hearing
We guide you through a dedicated preparation process for your oral hearing with the G-BA – enabling you to present with confidence and argue your case convincingly.
Tailored national HTA dossiers
Depending on your needs, we prepare either a complete benefit dossier or provide targeted support for individual modules – always adapting our services flexibly to your specific requirements.
In close cooperation with you, we develop a well-founded strategy to build a robust evidence base that not only meets regulatory expectations but also provides a solid foundation for successful price negotiations.
Systematic Research
Relevant studies form the basis for a robust comparative evidence base – and should be identified early and systematically.
We conduct systematic literature reviews (SLRs) and clinical trial registry searches in accordance with the methodological requirements of HTA authorities.
Successful Pricing Strategy & Reimbursement Negotiations
A market-aligned, well-thought-out pricing strategy is essential for the market success of your product.
Our dedicated pricing team provides comprehensive support in developing your pricing and reimbursement strategy – from the initial analysis to the final negotiations.
With our expertise, we guide you through the entire process: from preparing a compelling benefit dossier (including cost calculations and patient population estimates) to negotiation readiness and strategic communication with reimbursement authorities.
Market Access Consulting
In close collaboration with you, we develop a targeted value story and a coordinated evidence and pricing strategy.
- Strategic alignment of evidence and reimbursement – Early alignment of your evidence strategy with the requirements of price negotiations
- Compliance with HTA bodies – Ensuring your evidence is fully aligned with the standards set by G-BA and IQWiG
- Strong market positioning – Clear, scientifically grounded arguments for successful communication with reimbursement bodies
We support you throughout the entire market access process – from benefit assessment to price negotiation – ensuring that your evidence not only meets HTA standards, but also provides a strong foundation for reimbursement discussions.
Epidemiology & derivation of patient numbers
Accurately determining and presenting patient numbers is essential for reliable market analysis and sound strategic decisions. With our expertise, you gain a science-based, market-focused analysis that supports your strategy with confidence.
-
- Data-driven & evidence-based – Using current scientific sources and registry data
- Market & health care scenarios – Considering relevant trends for precise forecasting
- Strategic relevance – Reliable patient numbers as a basis for successful decisions
We support you in developing a realistic and robust estimate of your target population.
Statistical Analyses & Consulting
Comparative evidence is often the key to a successful benefit assessment. To meet HTA requirements effectively, it is crucial to consider the specific methodological criteria at an early stage.
Our experienced HTA statistics team provides expert guidance on endpoints such as patient-reported outcomes (PROs), develops HTA-compliant analysis plans, and supports you with complementary analyses based on primary data from your original studies, along with a wide range of relevant statistical evaluations, including:
- Indirect comparisons and network meta-analyses – generating robust evidence even in absence direct head-to-head studies
- Simulation studies and sensitivity analyses – providing a solid basis for decision-making
- Surrogate validation – scientifically sound substantiation of clinical endpoints
Rely on our statistical expertise to strengthen your evidence base, meet HTA expectations, and position your product strategically for success.
Written Statement
The Written Statement is a critical step in strategically addressing the benefit assessment and reinforcing your evidence base. Together, we identify evidence gaps, develop a targeted line of argument, and ensure that your position is communicated clearly and convincingly.
- Proactive Preparation – Gap analysis to identify critical issues early and develop key arguments
- Strategic Response – Precise, scientifically grounded argumentation tailored to the benefit assessment
- Dynamic Adaptation – Rapid delivery of additional analyses to reinforce your evidence base
With our support, you can respond quickly, effectively, and with confidence to the benefit assessment – ensuring optimal positioning within the HTA process.
Training & Preparation for the Oral Hearing
We guide you through a dedicated preparation process for your oral hearing with the G-BA – enabling you to present with confidence and argue your case convincingly.
- Setting the Scene – Crafting a compelling and well-structured opening statement
- Confident Delivery – Strengthening your argumentation skills through focused, practical coaching
- Simulated G-BA Hearing – Realistic rehearsal, including practice in responding to challenging questions
With our structured training and realistic simulations, you’ll be fully equipped to appear confident, prepared, and persuasive during your G-BA hearing.
Successful Pricing Strategy & Reimbursement Negotiations
A market-aligned, well-thought-out pricing strategy is essential for the market success of your product.
Our dedicated pricing team provides comprehensive support in developing your pricing and reimbursement strategy – from the initial analysis to the final negotiations.
With our expertise, we guide you through the entire process: from preparing a compelling benefit dossier (including cost calculations and patient population estimates) to negotiation readiness and strategic communication with reimbursement authorities.
How are the JCA dossier & the AMNOG dossier connected?
The Delta Dossier serves as the strategic interface between the EU HTA and the national benefit assessment in Germany. It is a supplementary national dossier required to address country-specific requirements that go beyond the scope of the European Joint Clinical Assessment (JCA). These include, among others, subgroup analyses, considerations of the healthcare context, and cost comparisons within the German healthcare system.
As such, the Delta Dossier is essential for the positioning of a medicinal product in the national context – both in terms of evidence tailored to the national setting and pricing strategy. It lays the foundation for a compelling value story in the AMNOG process and plays a key role in supporting successful price negotiations.
Biostatistics
Since the introduction of the AMNOG in 2011 in Germany, we provide our clients with comprehensive advice and support on all biostatistical issues concerning German benefit dossiers. We develop strategies to meet the requirements of IQWiG and the G-BA and at the same time achieve the best possible result for your product. Over 25 biostatisticians support you in all statistical aspects during the entire benefit assessment process.
Our services include
Methodology
- Direct and indirect comparisons (adjusted/non-adjusted, historical and external control groups)
- (Network) meta-analyses
- Propensity score matching
- Matching-adjusted indirect comparisons (MAIC)
- Surrogate validations
- Survival time analyses
- Multiple regression
- …and other methods
Feel free to contact us
Additional Analyses
For your benefit dossier, we carry out all additionally required statistical analyses according to the current requirements of IQWiG and G-BA and support you in communicating with your global colleagues.
Data Visualization (ShinyViz)
Fast visualization and individualized graphical presentation of analysis results to determine the best possible dossier strategy.
European HTA
At AMS, we have been active in the field of EU HTA since 2015. Among other things, we support you in statistical evaluations related to Joint Scientific Consultation (JSCs), rapide Relative Effectiveness Assessments (rapid REAs) and Joint Clinical Assessments (JCAs).
Routine practice data collection (anwendungsbegleitende Datenerhebung, AbD)
As pioneers in the field of routine practice data collection (anwendungsbegleitende Datenerhebung, AbD), we will accompany you at every step through this recently established process. We offer strategic consultation, individually tailored workshops, active participation during the stakeholder participation process and preparation of study documents including study protocols and SAP.
References
