First two medicinal merchandise to endure EU joint medical assessments introduced
On 16 April 2025, the European Fee (EC) revealed a press launch asserting the launch of and particulars concerning the primary two medicinal merchandise to endure joint medical assessments (JCAs). This follows the EU’s joint well being know-how evaluation (HTA) system, which got here into impact on 12 January 2025, beginning with all new oncology medicines and superior remedy medicinal merchandise (ATMPs).
The primary drug is Ipsen’s (France) tovorafenib for the therapy of paediatric low-grade glioma. The drug is an orphan-designated kind II quickly accelerated fibrosarcoma (RAF) kinase inhibitor. In Could 2024, the FDA granted the drug accelerated approval within the US, the place it’s offered below the model identify Ojemda. For its JCA, the assessor is Eire’s Nationwide Centre for Pharmacoeconomics (NCPE) whereas Germany’s Institute for High quality and Effectivity in Healthcare (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) operates because the co-assessor.
The second drug is Iovance Biotherapeutics’ (US) Amtagvi (lifileucel), an ATMP. Whereas the EC has not said the model identify, it did state the worldwide non-proprietary identify (INN) of the ATMP as “autologous melanoma-derived tumour infiltrating lymphocytes, ex vivo-expanded”. Nevertheless, primarily based on this data, it may be deduced that this assertion references Amtagvi. In February 2024, this drug was additionally granted accelerated approval by the FDA for the therapy of sufferers with superior melanoma who beforehand obtained therapy with an anti-programmed cell loss of life 1 (PD-1) antibody, or with a v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) inhibitor, if BRAF V600 constructive, with or and not using a mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor. The assessor for the JCA is the French Nationwide Authority for Well being (Haute Autorité de santé, HAS) and the co-assessor is Poland’s Company for Well being Know-how Evaluation and Tariff System (Agencja Oceny Technologii Medycznych i Taryfikacji, AOTMiT).
These assessors and co-assessors will now produce a draft JCA report, which must be endorsed by the Member State Coordination Group on Well being Know-how Evaluation no later than 30 days following the adoption of a call by the EC granting advertising and marketing authorisation. Through the preliminary scoping section, the assessor will produce explicit analysis inquiries to be addressed by the JCA primarily based on the inhabitants, intervention, comparability, and outcomes (PICO) framework. As soon as the questions are outlined, builders may have a brief turnaround interval (100 days) to compile and submit their JCA dossiers. The EU-wide JCAs include each benefits and downsides. In EU markets with extremely developed HTA methods, akin to France and Germany, there’s a danger that the assessments will create a bureaucratic hindrance to well-functioning methods, doubtlessly delaying outcomes in markets that traditionally assured earlier entry to newly authorised therapies. In GlobalData’s Worth Intelligence (POLI) database, the common time to the primary HTA choice is 320 days in Germany and 311 days in France. Nevertheless, as each the French and German businesses are working as assessors, this will likely assist mitigate these issues. Moreover, the reform supplies a chance for smaller markets to develop and enhance their HTA methods.
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