Joint clinical assessment in Europe
Open questions regarding the HTA (Health Technology Assessment) Implementing Regulation.
CC – 04/2024
The joint clinical assessment of health
technologies (EU-HTA) is to start gradually from 2025. The EU-HTA harmonises
the clinical assessments of health technologies for medicinal products and
medical devices. Since the entry into force of Regulation (EU) 2021/2282 on 12 January 2022 and until the first joint European clinical assessments
actually take place in 2025, a great deal of coordination work is still
required. The timetable updated in February Roadmap for the EU-HTA, updated in February, illustrates this.
A lack of clarity
The European Commission plans to
publish a total of six implementing regulations by the end of 2024. A Draft of the first implementing regulation is now available. It sets
out procedural rules for cooperation in the preparation and updating of joint
clinical assessments as well as regulations on the exchange of information and
the involvement of experts. The European Commission has obtained an opinion on
this as part of a consultation. The German Social Insurance (DSV) gave a Feedback in this regard.
In the view of the DSV, the draft
implementing regulation makes it clear that without the submission of the
guidelines to be developed, including the methodology, there is still
insufficient clarity regarding the content and scope of joint clinical assessments
of medicinal products. This jeopardises the timely implementation of the EU-HTA
at national level. Not knowing the exact methodological requirements, it can be
assumed that not all assessments to be regularly submitted in Germany will be
included in the joint HTA report. Additional assessments would therefore have
to be submitted at national level. This duplication of work should actually be
avoided with the EU-HTA.
Improvements required
The DSV feedback includes comments on
the handling of indication changes during the authorisation procedure. The
current draft of the implementing regulation stipulates that the Joint Clinical
Assessment (JCA) subgroup should decide whether the joint clinical assessment
should be continued or restarted if there is a change in the therapeutic
indication during the centralised procedure compared to the original
application for marketing authorisation.
To ensure that joint clinical
assessments are accurate, relevant, of high quality and based on the best
scientific evidence available at the time, the DSV believes it is important
that the conditions and procedural steps for updating these assessments are
defined. However, from the point of view of the DSV, there is a lack of clarity
regarding the deadlines for updating the joint assessment. These are not
specified in more detail in the event of a necessary revision of the scope.
The DSV is also concerned about the
distortions that can arise from the fact that the Health Technology Developer
(HTD) can proactively submit new data without simultaneously submitting
potentially negative results. This arrangement appears attractive to a
developer if the newly obtained data could improve the HTA result. In the view
of the DSV, this regulation should therefore be cancelled.
DSV comments on these and other aspects
in its Feedback.
Background EU-HTA
With the help of HTA, the added value
of new health technologies can be assessed in comparison to current standard
therapy. Up to now, HTA procedures occurred solely at national level, which
meant that health technology developers had to submit their documents several
times and sometimes in different formats for the evaluation procedures in the
individual member states. The EU-HTA procedure is intended to reduce this
administrative burden for developers and improve the quality of assessments in
accordance with the international standards of evidence-based medicine. The
joint assessment will provide national HTA organisations with scientific
information that they can use in their decisions on pricing and reimbursement
for a health technology. It was important to the DSV that the national HTA
organisations can decide for themselves to what extent they use and adopt the European assessment results.