EU HTA & AMNOG Q&A
The best strategy starts with the right questions
When it comes to EU HTA and AMNOG, asking the right questions early can save time, resources – and unnecessary surprises later.
If you’re preparing a JCA or AMNOG submission, building your HTA strategy, or simply looking for practical advice from people who work with these procedures every day, we’d love to talk.
We’re opening dedicated 30-minute Q&A sessions with our senior HTA and AMNOG manager.
No matter whether your questions are strategic or operational, broad or highly specific – we’re happy to discuss them with you in a confidential, noncommittal setting.
Whether you’re wondering about PICO anticipation, evidence generation, completeness checks, timelines, or the German AMNOG process, we’re here to help.
Disclaimer
Non-binding initial assessment
The information, assessments and recommendations we provide are given to the best of our knowledge and belief, based on the information made available to us in connection with your enquiry or an initial consultation.
As we do not, as a rule, have access at this stage to all relevant facts, nor to the full body of research, regulatory documents, scientific publications or other information relevant to decision-making, our assessments can be based solely on the information available to us. They therefore represent an initial professional guidance and cannot replace a comprehensive analysis of the specific case in question.
Informative Nature
All content, recommendations and guidance are provided solely for information and advisory purposes. They do not constitute legally binding, regulatory, medical, scientific or any other form of definitive expert advice.
In particular, our assessments do not replace individual legal, regulatory or medical advice. We strongly recommend seeking additional independent expert advice where necessary.
Special note on AMNOG, EU HTA and regulatory issues
Insofar as our information or recommendations relate to topics such as market access, benefit assessment, the AMNOG procedure, the HTA regulation, Joint Clinical Assessments (JCA) or comparable regulatory issues, these are exclusively professional assessments based on the information available at the time of the enquiry.
Our statements do not constitute either a prediction or a guarantee regarding subsequent assessments or decisions by authorities or institutions – in particular the Federal Joint Committee (G-BA), the Institute for Quality and Efficiency in Health Care (IQWiG), the European Medicines Agency (EMA), other HTA organisations or other national or international authorities.
Liability
Although we compile all information with the maximum possible care and to the best of our knowledge, we do not guarantee its completeness, accuracy, timeliness or suitability for a particular purpose.
We accept no liability for decisions, actions, financial consequences or other damages arising directly or indirectly from the information or recommendations we provide.
Confidentiality and Data Protection
The protection of your information is our top priority.
We treat all information, documents and details that you provide to us during a consultation or in response to an enquiry as strictly confidential. Such information will only be disclosed to third parties where there is a legal obligation to do so or where you have expressly given us your prior consent.
The information you provide will be used exclusively to process your enquiry and to prepare the requested initial assessment. It will not be used for any other purposes, nor will it be used for the development, improvement or training of artificial intelligence or similar systems.
We naturally comply with all applicable data protection regulations, in particular the provisions of the General Data Protection Regulation (GDPR).
No establishment of a contractual relationship
Submitting an enquiry and receiving a non-binding initial assessment do not establish either a consultancy relationship or a service contract. A binding consultancy or project relationship is established solely through a separate written agreement or an explicit commission. However, please feel free to contact us for a proposal.
