EU HTA: European Health Technology Assessment

With the entry into force of the Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU in January 2022, the clinical evaluation of health technologies will gradually take place at European rather than national level (EU HTA) from 2025 on. The decision on the additional benefit as well as the amount of reimbursement will continue to be the responsibility of the member states.

Overcoming uncertainties
Even though the EU Commission and Parliament have agreed on the wording of the regulation after more than 3 years, many questions currently remain unanswered due to outstanding procedural rules and method papers:

• How will the procedural processes at European and national level be coordinated in terms of timing?
• To what extent must additional information be submitted at national level?
• Which requirements apply to the methodology of the data to be presented and according to which criteria is the benefit assessment performed?
• According to which criteria is the ACT determined and will this also be required for orphan products?
• To what extent do possible differences in the standards of care in the member states play a role here?

These uncertainties significantly complicate the planning security for pharmaceutical companies and require a comprehensive and flexible strategy development not only for each indication but also for the general organizational set-up of the involved departments such as Market Access, Medical Affairs, Regulatory and others.

Gain an overview early on and use transferable resources
Particularly at the beginning of the implementation of new regulatory frameworks, it is important to draw on existing expertise and keep up with newly available information such as timeline updates or the content of tertiary legal acts. Only in this way can implications of the changing conditions be derived, and consequences implemented in a timely manner.

Years of experience with the AMNOG procedure enable us to achieve the best possible results together with our clients also within the framework of the EU HTA and not to lose sight of the goal: a positive benefit assessment in all countries involved. For the most important European market, Germany, this represents an optimal preparation for the price negotiations with the National Association of Statutory Health Insurance Funds (GKV-SV).

Thinking from the end
Even if the clinical evaluation of the available evidence will change, the regulation has no currently foreseeable impact on the course of price negotiations with the GKV-SV. Optimal strategic alignment with the price negotiations remains the most important goal of the process. The following continues to apply: we think from the end and anticipate all challenges from the beginning.

Being there from the start
We have accompanied the development of the joint European clinical assessment of health technologies since the idea was conceived and are actively involved in shaping the EU HTA within the EUnetHTA 21 stakeholder network. In this way, we also keep up with current developments and new available information and can use this directly for indication-specific as well as holistic strategy development for our clients.

Drawing on our extensive experience
Based on extensive experience in dealing with the German Institute for Quality and Efficiency in Health Care's (IQWiG)methodological requirements, which are high by international standards, and which will also be reflected in the EU HTA, we create an evidence-based benefit argumentation tailored to the project that conveys a convincing core message - in the end, it is still the German Federal Joint Committee (G-BA) that decides.

Agilely defying uncertainties
The German market access process is clearly structured and predictable, but already characterized by VUCA (volatility, uncertainty, complexity, ambiguity) due to external influences, especially in dossier creation. Our many years of consulting experience have shown that the necessary flexibility, speed and efficiency are achieved in particular through an agile work organization. We are confident that the agile way of working, characterized by short communication channels and a constant flow of information, equips us and our clients for the growing uncertainty that the EU HTA will bring.