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.