EU HTA: Here we go
Implementing Act on JCA published
The EU HTA Regulation came into force on 12 January 2022, and the one-year countdown for the start of the EU HTA process for oncology and advanced therapy medicinal products (ATMPs) has been running since January 2024. However, even those manufacturers who will not be affected until 2028 (orphans) or 2030 (all other new medicines) are making initial strategic preparations in order to adapt to the new process at an early stage and thus position themselves in the best possible competitive position. The strategic preparations to date have been based primarily on hypotheses and scenarios derived from the results of EUnetHTA 21 and the experience gained from comparable national assessment procedures, in particular the German benefit assessment and the German dossier. This pioneering role of Germany in the EU HTA process and in the development of the Joint Clinical Assessment has been repeatedly acknowledged by stakeholders in recent months - and has now been confirmed once again.
Today, on 05 March, the first implementing act for the implementation of the EU HTA Regulation was published after some delay. The simple questions are: What's in it? What is not in it yet? What happens next? And what does it mean for me and my team?
Included is the template for the JCA dossier, essentially reconfirming the AMNOG dossier in Germany as a template for structure and content. The scope of the assessment report, on the other hand, is, as before, rather roughly defined.
The PICO scoping process as the core of the new procedure is also defined. It is based on the submitted EMA documents, such as the clinical overview and the proposed SmPC (Summary of Product Characteristics). However, the pharmaceutical manufacturer (here: Health Technology Developer, HTD) is still only involved as "if considered necessary, in meeting or writing". Accordingly, an initial PICO proposal from the HTD is apparently not planned.
The process for the involvement of external stakeholders by the HTA Secretariat is described in detail, although relativizations and room for interpretation can be found in various places, e.g. "at any time", "if considered necessary".
The timeline is essentially retained: 90 days from PICO confirmation to dossier submission - although "sufficient time" is still mentioned in some specific places, particularly in the case of delays and subsequent submissions. Spontaneous changes to the label are nevertheless particularly emphasized under Article 16, and may lead to a new PICO scoping - but again at the discretion of the HTA authorities.
Overall, we would certainly have liked to have seen more consideration of the industry perspective, for example with mandatory participation in PICO scoping or an adjustment towards a better implementable timeline for manufacturers. Either way, preparations are continuing. We at SKC help our clients on the path of strategic development from recommendations for action to concrete implementation, and are happy to support you right from the start with our customized and up-to-date Readiness Workshop. We will now analyze the Implementing Act in detail and accordingly incorporate it in our work. With the publication of the other Implementing Acts and ultimately the national procedural regulations, process reliability will be formally increased gradually, but there will still not be complete clarity and reliability until the regulation is actually implemented and the first European assessment procedures are carried out. On the other hand, experience has shown that the establishment of such extensive, complex processes (cf. AMNOG in 2011) is slow in the first few years, meaning that further adjustments can be expected.
The published draft of the Implementing Act can now be commented on in a four-week comment process until April 2. As before, we will actively participate in this review process on the national and international stage, both independently and together with various associations. We will incorporate all our assessments of the developments and their implications as well as (potential) news from Brussels into our advice to our clients on a daily basis. We will keep you up to date!
Sources:
About the author
M. Sc. Life Science
Fax: +49 511 64 68 14 18
