D+C Services
EU Health Technology Assessment (EU HTA)
We provide you with key strategic and scientific advice to navigate through uncertainty and succeed in the new HTA landscape
Challenges
The new European HTA system will standardize market access for 27 member states. There will be one HTA dossier for the entire EU, which will make it possible to use resources more effectively in the medium term. However, this will inevitably mean that the standardized processes will be more complex than those of a single Member State. These new structures will also have an impact on national HTA systems. We help our partners to prepare for these changes and offer concrete solutions to successfully manage the uncertainties of the new system.
EU-wide approval by EMA + National HTA procedures and reimbursement agreement with wide variety of methods
One centralized and harmonized EU HTA process for the benefit of the member states and ultimately of the patients
This will pose challenges to multiple functions and workstreams across pharmaceutical developers, from R&D to market access:
EU HTA impact on Evidence Requirements
Complex new data quality requirements for EU HTA dossier
Additional data quantity requirements for EU HTA dossier
Uncertainty of HTAR Framework
Unpredictable procedures and processes on EU-level
Unclear timelines and interactions between developers and HTA CG
HTAR impact on national Market Access frameworks
Implications of EU HTA introduction on national decision-making frameworks
Complex new EU PICO system will become standard for appraisal frameworks
Solutions
To navigate through the uncertainties of EU HTA successfully, you need to consider the following:
Completeness
Ensure EU HTA submission dossier addresses all new technical and formal requirements adequately.
Deadline Monitoring
Meticulously plan, align, monitor and ensure adherence to all deadlines, especially with focus on interdependencies between the regulatory and EU HTA frameworks.
Due Diligence
Cross-check and validate outputs and processes in compliance with the new EU HTA framework. Ensure interlinked procedures and cross-links to the EU Regulatory work (EMA) are appropriately integrated.
System Understanding
Establish detailed maps of new EU HTA framework and processes, navigating new complexity and continuously changing cross-links to regulatory processes.
Methods & PICO
Ensure implementation and adherence to new methodological requirements. Implement PICO focused data pathways.
Quality
Establish a robust and adaptive quality control process encompassing the changed requirements and responsive to ongoing procedural and methodological changes.
Usability
Establish processes that facilitate the usability of the centralized EU HTA (JCA) Report on member state level.
D+C Services
EU HTA Service Suite
We assist you in implementing changes across the whole product lifecycle and successfully operating in the new EU HTA framework
Evidence generation and presentation requirements
HTAR Alignment Service
Submission dossier compliance check
Ex-Post Economic Assessment Data Prep
EU HTA Methodology Compliance
National Supplements Evaluation
HTACG compliance check
New EU
Legal Framework
Procedural Risks Assessment
New Procedure Guidance
Product-Specific Communication Support
Assessor-Specific Consistency Check
MS HTA Dossier Guidance Preparation
Timeline Management and Analysis
Communication Preparation with Relevant Bodies
Communication Support and Guidance
Joint Early Dialogue Access Offering
HTAR
Impact
Timelines Planning and Reg Procedure Impact Analysis
Risk Management and Early HTA Dossier Planning
Planning National Procedures and EU Impact
Preparing National Data Requirements
Preparing Appraisal Process Impact
Aligning Launch Strategy with Impact Analysis
Forecast of MS Resource Limitations
Resource allocation optimisation
Implementation of Organizational changes
Appraisal Process Impact on National Level
Guidance on PICO Formulation
Support on EU PICO Preparation Linked to Data Generation
Why Dierks+Company
With our extensive experience and expertise in HTA processes in Germany and Europe and our in-depth knowledge of European health policy and regulations, we help our clients succeed in a changing and complex regulatory landscape by giving them the tools they need.
One-Stop-Shop
Guided by a team of experts, former leaders and co-creators of the new EU HTA process, we ensure your success through comprehensive support in navigating the entire EU HTA process
Legal + Strategy
We combine legal consulting with strategic thinking
Extensive network
We are well connected with decision makers and stakeholders of the European healthcare system
Marcus Guardian
Expert in Health Technology Assessment and shaper of EU HTA as former Chief Operating Officer of EUnetHTA
Juliana Dierks
Co-founder of Dierks+Company. Prior to this, she held top management positions in the pharmaceutical and healthcare industry worldwide, most recently at Shire as "Global Head of Hematology"
Dr. Dominik Roters
Legal expert, former Deputy Managing Director and Head of the Legal Department at the Federal Joint Committee (G-BA)
Interested?
Send us a message or book a meeting directly with Marcus.
Contact
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