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

EU Health Technology Assessment



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

JSC | Joint Scientific Consultation

One centralized and harmonized EU HTA process for the benefit of the member states and ultimately of the patients

JCA | Joint Clinical Assessment

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


To navigate through the uncertainties of EU HTA successfully, you need to consider the following:


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.


Establish a robust and adaptive quality control process encompassing the changed requirements and responsive to ongoing procedural and methodological changes.


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


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.


Guided by a team of experts, we ensure your success through comprehensive support in navigating the entire EU HTA process

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)


Send us a message or book a meeting directly with Juliana.

Juliana Dierks

Strategy | Managing Partner

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