The First Joint Clinical Assessment Report Published in the EU under the New HTA Regulation
Published 29 June 2026
Last update 22 July 2026
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The European Commission has published the first Joint Clinical Assessment (JCA) report – a joint clinical evaluation by EU Member States under the new Health Technology Assessment (HTA) Regulation.
The Joint Clinical Assessment is designed to analyse clinical evidence, including the relative efficacy and safety of a technology compared with existing alternatives.
The results of the JCA are to be used by national HTA agencies in EU Member States during subsequent health economic evaluation procedures, pricing decisions, reimbursement, and financial coverage of the technology.
It is important to note that the economic evaluation and subsequent decisions on pricing and reimbursement remain within the competence of the EU Member States.
⚙️ How the new HTA system in the EU is developing
Regulation (EU) 2021/2282 has been applicable since 12 January 2025.
In the first phase, Joint Clinical Assessment is conducted for:
— new oncology drugs
— Advanced Therapy Medicinal Products (ATMPs)
From 2028, orphan medicinal products will be included in the procedure, and from 2030 – all other pharmaceutical products undergoing the centralised marketing authorisation procedure in the EU.
📄 The first JCA report
The first published JCA report has been prepared for the drug **tovorafenib (Ojemda)** by Ipsen Pharma.
The drug is indicated for the treatment of patients from 6 months of age with paediatric low-grade glioma associated with a rearrangement/fusion of the BRAF gene or a BRAF V600 mutation, who have progressed following one or more lines of systemic therapy.
The Joint Clinical Assessment procedure involves the preparation of a report by one of the expert HTA organisations in Europe, with the participation of a second organisation as a co-assessor, followed by approval of the report by the Member State Coordination Group on Health Technology Assessment (HTACG).
In this case, the expert organisation was the National Centre for Pharmacoeconomics of Ireland, and the joint assessment was carried out with the participation of the German HTA agency IQWiG.
The report was approved by the HTACG and published in June 2026.
📊 Key finding of the first joint assessment
The available evidence base for tovorafenib remains limited.
The primary study was open-label, non-randomised, and non-comparative; therefore, direct comparative data for most populations, comparators, and outcomes were absent.
A comparative assessment of relative efficacy was only possible for one patient subgroup and was based on indirect comparison, which is associated with substantial uncertainty.
It was also noted that there is a lack of comparative data for a number of outcomes that are important to patients and their families, including quality of life, disease symptoms, and fatigue.
🔎 Why this matters
The results of the Joint Clinical Assessment will now be used in subsequent health economic evaluation procedures at the national level.
It will be particularly interesting to see what pricing and reimbursement decisions individual EU countries will make based on these clinical data.
The preparation of joint reports is an example of HTA harmonisation as a post-market access stage following centralised authorisation through the EMA.
This approach is well-founded: clinical data are largely universal across countries, whereas economic data remain country-specific.
Joint Clinical Assessment following centralised authorisation makes it possible to harmonise approaches, reduce duplication of effort, and avoid unjustified costs. This experience may also be useful for the EAEU countries.
👥 In accordance with the Joint Clinical Assessment procedure, patient organisations and caregivers also participate in the process.
In our following posts, we will share with you the comments provided by patient organisations in Europe on the results of the first Joint Clinical Assessment.
📎 Link to the European Commission report
The Joint Clinical Assessment is designed to analyse clinical evidence, including the relative efficacy and safety of a technology compared with existing alternatives.
The results of the JCA are to be used by national HTA agencies in EU Member States during subsequent health economic evaluation procedures, pricing decisions, reimbursement, and financial coverage of the technology.
It is important to note that the economic evaluation and subsequent decisions on pricing and reimbursement remain within the competence of the EU Member States.
⚙️ How the new HTA system in the EU is developing
Regulation (EU) 2021/2282 has been applicable since 12 January 2025.
In the first phase, Joint Clinical Assessment is conducted for:
— new oncology drugs
— Advanced Therapy Medicinal Products (ATMPs)
From 2028, orphan medicinal products will be included in the procedure, and from 2030 – all other pharmaceutical products undergoing the centralised marketing authorisation procedure in the EU.
📄 The first JCA report
The first published JCA report has been prepared for the drug **tovorafenib (Ojemda)** by Ipsen Pharma.
The drug is indicated for the treatment of patients from 6 months of age with paediatric low-grade glioma associated with a rearrangement/fusion of the BRAF gene or a BRAF V600 mutation, who have progressed following one or more lines of systemic therapy.
The Joint Clinical Assessment procedure involves the preparation of a report by one of the expert HTA organisations in Europe, with the participation of a second organisation as a co-assessor, followed by approval of the report by the Member State Coordination Group on Health Technology Assessment (HTACG).
In this case, the expert organisation was the National Centre for Pharmacoeconomics of Ireland, and the joint assessment was carried out with the participation of the German HTA agency IQWiG.
The report was approved by the HTACG and published in June 2026.
📊 Key finding of the first joint assessment
The available evidence base for tovorafenib remains limited.
The primary study was open-label, non-randomised, and non-comparative; therefore, direct comparative data for most populations, comparators, and outcomes were absent.
A comparative assessment of relative efficacy was only possible for one patient subgroup and was based on indirect comparison, which is associated with substantial uncertainty.
It was also noted that there is a lack of comparative data for a number of outcomes that are important to patients and their families, including quality of life, disease symptoms, and fatigue.
🔎 Why this matters
The results of the Joint Clinical Assessment will now be used in subsequent health economic evaluation procedures at the national level.
It will be particularly interesting to see what pricing and reimbursement decisions individual EU countries will make based on these clinical data.
The preparation of joint reports is an example of HTA harmonisation as a post-market access stage following centralised authorisation through the EMA.
This approach is well-founded: clinical data are largely universal across countries, whereas economic data remain country-specific.
Joint Clinical Assessment following centralised authorisation makes it possible to harmonise approaches, reduce duplication of effort, and avoid unjustified costs. This experience may also be useful for the EAEU countries.
👥 In accordance with the Joint Clinical Assessment procedure, patient organisations and caregivers also participate in the process.
In our following posts, we will share with you the comments provided by patient organisations in Europe on the results of the first Joint Clinical Assessment.
📎 Link to the European Commission report
