These drugs are being evaluated jointly across Europe. Three new therapies have been added to the list.
- On 12 January 2025, the HTA Regulation entered into force, enabling Member States to conduct joint clinical assessments of medicines
- In April, the European Commission announced the launch of the first two joint assessments
- In May, another product was added to the list of drugs subject to joint clinical evaluation, and in July, three new therapies
- In total, 6 products are already included in the joint clinical drug assessment.
- Two of them are advanced therapy medicinal products (ATMPs) and three have been granted orphan drug status.
- The Polish Agency for Health Technology Assessment and Tariff System is participating in the evaluation of one of the drugs.
The latest update of the list of products subject to Joint Clinical Assessment (JCA) under the EU Health Technology Assessment Regulation (EU 2021/2282) added three new medicines:
- onasemnogen abeparvovec from Novartis
It is an advanced therapy medicinal product (ATMP) for the treatment of 5q spinal muscular atrophy (SMA), with orphan drug designation.
The Irish National Centre for Pharmacoeconomics is acting as assessor, and the French National Authority for Health is co-assessor. The EMA approved the marketing authorization application on May 22, 2025.
- PharmaMar's lurbinectedin
The drug is indicated for the treatment of lung cancer, with orphan drug designation. The assessor is the German Institute for Quality and Efficiency in Health Care (IQWiG), and the co-assessor is the Portuguese National Authority for Medicines and Health Products (INFARMED).
The EMA approved the marketing authorisation application on June 19, 2025.
- AstraZeneca's camiestrant :
This product is intended for the treatment of adults with locally advanced or metastatic breast cancer.
The function of assessor and co-assessor is performed by the Austrian Österreichische Sozialversicherung and the National Institute for Health and Disability Insurance from Belgium.
EMA validation took place on June 19, 2025.
This means that six products are now in the joint clinical drug evaluation process. Two of these are advanced therapy medicinal products (ATMPs) and three have been granted orphan drug status.
On 12 January 2025, the HTA Regulation entered into force, enabling Member States to conduct joint clinical assessments of medicines.
In April this year, the European Commission announced the launch of the first two joint assessments, which are being carried out by assessors and co-assessors from competent organisations in EU Member States, as well as in Norway, Iceland and Liechtenstein.
The first two preliminary evaluations were for these therapies:
- tovorafenib licensed by Ipsen in collaboration with Day One Biopharmaceuticals
This treatment is for children with low-grade glioma. The drug has already been approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory low-grade glioma in children with BRAF fusion, rearrangement, or V600 mutations, following results from the ongoing pivotal Phase 2 FIREFLY-1 clinical trial.
The EMA accepted the application for registration for review earlier this year. The evaluation is being conducted by the Irish National Centre for Pharmacoeconomics, with the German IQWIG acting as co-assessor.
- lifileucel by Iovance Biotherapeutics
This is an advanced therapy medicinal product for the treatment of melanoma.
Lifileucel is the first FDA-approved TIL (autologous tumor-infiltrating lymphocyte) therapy for solid tumors, offering a new option for patients who have progressed on prior anti-PD1 and targeted therapies.
In the EU, the marketing authorization application is currently being reviewed by the EMA. The French National Authority for Health is conducting the assessment as the assessor, and the Polish Agency for Health Technology Assessment and Tariff System is acting as the co-assessor.
In May of this year, sasanlimab was added to the JCA list of drugs evaluated for the treatment of bladder cancer. The Dutch National Health Care Institute and the Danish Medicines Council are conducting the evaluation.
Joint clinical assessment of medicines is a solution implemented at the EU level, the aim of which is to shorten the time of this assessment and accelerate the provision of new medicines to patients.
The entire process takes place on three levels and involves teamwork. These include a horizon scanning group, which identifies potential therapies at early stages; a Joint Scientific Consultation (JSC ) group, which conducts joint scientific consultations; and a Joint Clinical Assessment (JCA) . AOTMIT staff are present in each team.
Poland has also joined the consortium of national HTA bodies, which signifies its willingness to conduct assessments during both the JCA and JSC periods. You can become a lead assessor or a co-assessor.
In the case of the six therapies mentioned above, the Polish Agency became a co-assessor in the case of the assessment of therapies for the treatment of melanoma.
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