Herbert Altmann, PhD, Head of Market Access, Pricing and Reimbursement at Cencora (formerly AmerisourceBergen). 

Jai: How early will pharmaceutical companies need to start their preparation for the implementation of the EU-HTA regulation (JCA (Joint Clinical Assessment))  

Altmann: Companies should begin their JCA-specific internal market access planning at least ten months before the anticipated EMA (European Medicines Agency) regulatory file submission so they have sufficient time to prepare for the JCA-dossier requirements and consolidate a high-quality evidence package. Alignment on internal processes should start after the Phase 2 clinical data is read out, ideally before finalising the Phase 3 clinical trial design. 

As part of the planning process, companies should prioritise efforts that drive broader cross-functional understanding of the new processes and JCA-dossier requirements and seek to leverage key insights, early JCA submissions and already concluded Joint Action 3 (JA3) pilot assessments. Deeper understanding will help companies define their strategy and align on a smooth action plan for JCA submissions. For example, companies can work with their market access partners to conduct scenario testing, expert interviews, and consolidation workshops —all of which will help inform their JCA strategy as part of the overall launch strategy. 

Jai: How can the companies developing oncology medicines or ATMPs (Advanced Therapy Medicinal Products) leverage Joint Scientific Consultations? 

Altmann: As you know, the JCA process will go live and become mandatory for oncology drugs and ATMPs on January 12, 2025. We expect the first JCA dossiers will be submitted by manufacturers (so-called Health Technology Developers (HTD)) around the Sep 2024 timelines. These HTDs now have less than a year to engage with the new regulation and its processes to ensure they are well-positioned to efficiently manage the requirements on their way to finally launching their products across Europe.  

The Joint Scientific Consultations (JSC) serves as a great opportunity, enabling companies to seek scientific advice from national Health Technology Assessment (HTA) bodies and the European Medicines Agency (EMA) before finalising their pivotal clinical trial designs (phase 2 or 3). JSC applications are now coordinated by Germany’s G-BA until the final set-up of the secretariate is decided and implemented. By receiving such valuable scientific advice, companies will be better positioned to develop the best possible evidence package for all future HTA assessments, including pan-EU and individual member states. 

Jai: What are some of the key milestones in the preparation of the JCA dossier? 

Altmann: I briefly mentioned this earlier, but companies need to be familiar with the JCA and JSC templates, evidence requirements and timelines of the process. The tight JCA procedure timeline in terms of dossier preparation, coupled with lingering questions for local HTA processes, underscores the importance of organisational readiness and early planning. 

When aligning their internal timelines, companies should aim to complete – or initiate – several key milestones prior to the start of the JCA procedure: vendor selection, PICO simulation, strategic planning, evidence review and a first draft of the dossier. Strategic planning should involve building cross-functional capacity and capabilities, which are critical to execute the JCA-process and subsequent country HTA processes. 

Jai: What lessons have we learned from the pilots? 

Altmann: Many of the key takeaways reaffirm what we anticipated, but we also had significant learnings about the potential impact of the new regulation. While the JCA framework holds the potential to help spur pharmaceutical innovation and reduce barriers that can delay access to therapies approved by the EMA, it is a vast undertaking for all involved stakeholders and presents significant complexities to overcome.   

In addition to headquarter organisational readiness, it is more critical than ever for pharmaceutical companies’ local affiliates to engage with national HTA bodies, ensuring a robust collaboration throughout the process. That is particularly important for emerging pharmaceutical companies – which may not have well-established local market access teams yet are covering two-thirds of the molecules in the global R&D pipeline. 

Our market access team continues to work closely with pharmaceutical companies to deliver JSC support and JCA-process preparation and implementation guidance within their broader market access strategy, helping to successfully support the path to market authorisation.