How are local markets adapting their HTA evaluations considering EU HTA ? 

Introduction

With all new oncology medicines and ATMPs being assessed from January 2025 the implementation of the EU HTA process is rapidly approaching, leaving both member states and manufacturers with little remaining time to prepare. The EU HTA regulation states that member states will give “due consideration” to JCA results, meaning that the JCA report should be part of the documentation considered within the national HTA process.  However, they are not obliged to adopt the outputs of the JCA and can also request complementary analyses. This creates potential for variation between member states in terms of how the JCA is used and the extent to which complementary analyses will be requested. 

To date, EU member states have provided relatively little insight on how they plan to integrate the EU HTA outputs into national processes. However, there are markets that have provided some direction, as outlined below. This article will discuss member states that have made statements on how national HTA may or may not be adapted considering the EU HTA. 

Which countries have indicated that minimal changes will be made to their national pricing and reimbursement processes with the introduction of the EU HTA?

Germany has been integral in the development of the EU HTA process. The EU HTA methods have been developed in close collaboration between IQWiG and the G-BA, and the EU HTA procedure has strong parallels to that of AMNOG¹. The JCA dossier has also used the AMNOG dossier as a template for structure and content². However, as the information, data, and analyses submitted by pharmaceutical companies at EU level cannot be requested at national level, the German government has stated it is committed to maintaining all relevant AMNOG procedures¹. Moreover, whilst Germany expects to incorporate JCA analysis similarly to assessments by IQWiG, the analysis will not affect their process for determining level of additional benefit. Germany therefore is resisting deviation from national processes and will likely conduct an extensive national P&R process with additional clinical and economic analysis.  

Which countries have expressed greater openness to adapting their national P&R processes with the launch of the EU HTA?

Unlike Germany, other member states appear more willing to integrate the EU HTA and adapt national evaluations to accommodate for the EU HTA. Austria exemplifies this, as AIHTA initiated a pilot project into HTA-methods and steering instruments to prepare Austria for the HTAR by adapting Austrian methods and document structures³. In addition to adapting existing country-level methods and documents by utilising EUnetHTA methods papers, the pilot project also aimed to raise awareness of EU HTA and develop a concept for the coordination of the needs of regional decision makers in order to inform HTAR Coordination Group³. These measures are being implemented with the intention of adapting national HTA and ensuring preparation for the launch of the EU HTA.  

In Spain, a royal decree on HTA will soon be made, introducing a model consisting of a three-phase access process to be conducted by Spanish Medicines Agency. The first phase would likely begin with the analysis of JCA reports for drugs subject to the EU HTA, and decision of the drug’s positioning with respect to therapeutic alternatives already available in the National Health System⁴. The upcoming changes to HTA in Spain indicate the intention to implement and utilise information gained from the EU HTA for national P&R purposes. 

The remaining Beneluxa countries appear similarly open to the alignment of national HTA processes to accommodate the EU HTA. The NCPE in Ireland, having active involvement in EUnetHTA 21, is similarly active in Co-ordination groups and sub-groups, demonstrating their commitment to actively considering the EU⁵ HTA http://vimeo.com/911150093.   

ZIN in the Netherlands has similarly demonstrated their readiness to adopt EU HTA, with preparations beginning at the end of 2022 starting with gap analyses. In Belgium, adoption of changes in preparation for joint HTA has not yet occurred but will likely begin following development of patient representative legislation and an early dialogue system. Luxembourg, whilst committed to implementing the EU HTA, has stated that rather than depending on the HTA decisions of Belgium, a system needs to be developed in Luxembourg ahead of the EU HTA⁵.  

Similarly to in the Netherlands, Sweden’s TLV has demonstrated its effort to integrate the JCA by participating in preparatory work at EU level to ensure functionality⁶. The TLV has stated it sees that “a central part of the national preparatory work is to adapt the national case handling processes to the processes at EU level. This is done, among other things, by mapping current processes, analysing the need for changes based on the requirements of the Regulation and developing a proposal for implementing this change.” However, even with the willingness to adapt national processes, there remains concerns about limited capacity to meet increased demand when the joint HTA launches, the lack of resources to ensure functionality, and the potential efficiencies gained from the joint HTA.  

Finally, the Director of the Centre for Evidence Based Medicine stated that for Croatia, whilst national level processes are not developed to the extent of other bigger markets, HTA capacities for systematic and sustainable HTA work at the national level and sustainable HTA collaboration at the EU level is being strengthened. There have been no definite statements as to how the JCA will be considered nationally, but it is expected that following the development and strengthening of HTA capacities, Croatia will actively participate in joint HTA work at the EU level⁷. 

Recent developments and implications for manufacturers

Whilst member states have given little insight into how national level processes will be adapted, there are other ongoing developments ahead of launch. An example of this is the cross-border HTA collaboration intended to support the EU joint HTA, SUSTAIN-HTA (Support the Utilisation of Sustainable an Tailored Innovative Methods). A key objective for this collaboration is to “support the Coordination Group on Health Technology Assessment (HTACG) and in particular, its subgroup on methodology”⁸. Moreover, eight unidentified EU have expressed an interest in forming a group to discuss voluntary cooperation on HTA, with the intention of exploring general rules, areas for voluntary cooperation, and possible connections to the existing networks of member states engaged in voluntary cooperation. 

Conclusion

The EU joint HTA will launch in less than a year, and whilst certain member states have made high-level statements on how existing national processes will be adapted, most have provided little or no insight on how they plan to integrate the EU HTA. This includes high-priority EU launch countries such as Spain and France. There therefore remains significant uncertainty on how the JCA will function alongside national processes, which has implications for manufacturers on how data is submitted and the level of additional work that may be required for drug launches moving forwards. At this point in planning, it might be prudent for manufacturers to assume that current country-specific pricing and reimbursement timelines will remain unchanged, at least in the short term. However, they should seek to remain up to date with the latest changes to allow for ample preparation.  

Explore EU HTA with our other resources:

Blogs:

• Navigating the EU HTA regulation

• Draft EU HTA JCA act for medicinal products

Webinars:

Sources:

1. EU HTA Impact on Innovations: Expectations and Challenges of EU HTA for Germany- HTA perspective. ISPOR. https://www.ispor.org/docs/default-source/euro2023/eu-hta-13-nov-2023-291023dietrich.pdf?sfvrsn=f59eb868_0#:~:text=The%20EU%20HTA%20is%20a,use%20for%20the%20AMNOG%20procedure.&text=Expectation%20Reality%20(%3F)&text=%E2%80%9CThe%20results%20of%20the%20European,account%20in%20the%20national%20procedure. Accessed 18^th April 2024 

2. Implementing Act on JCA published. SKC. https://skc-beratung.de/insights/blog/2024/03/first_implementing_act_on_JCA_published.php. Accessed 18^th April 2024 

3. HTAR (HTA-Regulation): Implementation in Austria. AIHTA. https://aihta.at/page/htar-hta-verordnung-implementierung-in-oesterreich/en. Accessed 18^th April 2024 

4. El RD de Evaluación establecerá tres niveles trabajo para separar evaluación y decision. Diariofarma. https://diariofarma.com/2024/04/14/el-rd-de-evaluacion-establecera-tres-niveles-trabajo-para-separar-evaluacion-y-decision. Accessed 18^th April 2024 

5. Panel 2 -The national perspective – Expectations, opportunities, and the challenges ahead. Vimeo. https://vimeo.com/911150093. Accessed 18^th April 2024 

6. Årsredovisning 2023: Beredskapsfrågor och uppdaterad värdebaserad prissättning i focus. TLV. https://www.tlv.se/press/nyheter/arkiv/2024-02-22-arsredovisning-2023-beredskapsfragor-och-uppdaterad-vardebaserad-prissattning-i-fokus.html. Accessed 18^th April 2024 

7. 14^th Croatian Cochrane Symposium – What kind of research is needed for our health system? Cochrane Croatia. https://croatia.cochrane.org/news/14th-croatian-cochrane-symposium-what-kind-research-needed-our-health-system. Accessed 18^th April 2024 

8. SUSTAIN HTA launched to advance and align innovative HTA methods in Europe. The Evidence Base. https://www.evidencebaseonline.com/sustain-hta-launched-to-advance-and-align-innovative-hta-methods-in-europe/. Accessed 18^th April 2024 

9. Flash report – Member State Coordination Group on HTA (HTACG) (8 March 2024). European Commission. https://health.ec.europa.eu/latest-updates/flash-report-member-state-coordination-group-hta-htacg-8-march-2024-2024-03-13_en. Accessed 18^th April 2024