EU-HTA: European Health Technology Assessment

The benefit assessment of health technologies (Health Technology Assessment, HTA) is of crucial importance for the success of the market access of innovative products in the EU. In Germany, in accordance with AMNOG (Act on the Reform of the Market for Medicinal Products), the extent of the additional benefit granted compared to the appropriate comparative therapy (ACT) determines the reimbursement negotiations with the statutory health insurers.

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.

The challenge

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.

The solution

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).

Our approach

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.

  • Discussion of new requirements and implications

    Conducting design thinking workshops to discuss the new requirements and strategic implications

  • Organizational development

    Conducting design thinking workshops to prepare the company

  • Strategic sparring & stress testing

    Support and / or review of initial joint scientific consultation (JSC) or joint clinical assessment (JCA) submissions, stress testing of the strategy

  • Full support Joint Scientific Consultation (JSC)

    Strategic and operational support for JSC application, strategic and operational support in the preparation and execution of the JSC

  • Full support Joint Clinical Assessment (JCA)

    Strategic and operational support during the JCA: from the development of the value story and the gap analysis, to the preparation of the benefit dossier and the signaling of inaccuracies.

  • Transfer of the EU-HTA results into the German context

    Seamless transfer of the EU-HTA process into the assessment by the German Federal Joint Committee (G-BA), as well as the strategic and operational preparation of the price negotiation with the National Association of Statutory Health Insurance Funds (GKV-SV)

Get in touch

Ihre Ansprechpartnerin Dipl.-Kauffrau Heike Kielhorn-Schönermark
Dipl.-Kauffrau Heike Kielhorn-Schönermark
Founder and Managing Director
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18
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