Presentation (CTI)

OBJECTIVES: To analyse how the mandatory EU Joint Clinical Assessment (JCA) could interface with regional joint pricing alliances, such as BeNeLuxA, Nordic Pharmaceutical Forum and the Valletta group and to assess the downstream consequences for European market-access pathways, including potential escalation to EU-level procurement under the draft Critical Medicines Act (CMA).
METHODS: Legislative texts, alliance process guidelines and recent statements by national HTA agencies were reviewed. A timeline model tracing EMA authorisation, JCA publication, economic assessment and joint price negotiation or procurement was constructed to estimate potential changes in time-to-access.
RESULTS: The JCA will deliver a single, publicly available dossier of comparative clinical evidence. HTA bodies (JNHB) have committed to importing that report wholesale and limiting their joint work to health-economic modelling which can then be leveraged by NPF for joint negotiations. Other groups, such as BeNeLuxA or Valletta may be expected to follow suit. Scenario analysis suggests that this shift could increase the likelihood of alliances conducting joint HTAs and shorten time-to-access significantly by removing the necessity to duplicate the clinical assessment and enabling more predictable, coordinated pricing discussions. In scenarios where products avoid or repeatedly fail to achieve market access, for example, ultra-rare therapies not launched in several countries or products whose low volumes make supply commercially unattractive, nine or more Member States can trigger EU-level joint procurement under the CMA. A completed JCA is the formal gateway to that mechanism.
CONCLUSIONS: JCAs are poised to become the clinical backbone of multi-country pricing dialogues in Europe. Alliances that synchronise their economic evaluation and negotiation processes with the fixed timelines of the JCA are well-positioned to deliver faster, more predictable access. In cases where regional negotiations stall, Member States may turn to the EU’s centralised CMA procurement mechanism as an alternative route to access.