Session (CTI)

Issue: The European Medicines Agency (EMA) has introduced accelerated regulatory pathways (APs) to enable earlier access to promising therapies, particularly in oncology, where there is high unmet medical need but comprehensive clinical data is not yet available. However, the corresponding processes for Health Technology Assessment (HTA) and pricing & reimbursement (P&R) differ across European countries. Some countries have introduced HTA APs and access funds, but these approaches vary substantially and face challenges, which is reflected in variable HTA and P&R decisions and, ultimately, unequal patient access. The introduction of the Joint Clinical Assessment (JCA) across European countries will bring significant change to HTA, though how APs will interact with JCA is uncertain. There is broad agreement that in areas with high unmet medical need timely patient access is particularly important. Hence, there is a need to develop a pan-European and stakeholder-endorsed framework for an AP that fits into existing HTA processes, including the JCA, and can be implemented consistently across health systems. Several components must be agreed upon between stakeholders and countries if APs are to be implemented consistently, including treatment eligibility, evidential requirements, pricing models, and enforcement mechanisms. Overview: The session will explore the feasibility of a pan-European AP for oncology. The moderator will introduce the issue and outline an AP framework (10 minutes). Panellists (10 minutes each) will present their perspective on the framework, including its promises, pitfalls, and opportunities for practical implementation. The aim is to share perspectives and identify common ground to progress the debate for APs. The panel will be particularly useful to HTA representatives and payers considering the implementation of accelerated pathways. The session will include interactive components, such as Q&A and polls, to ensure audience engagement. This session is based on work funded by AstraZeneca, GSK and MSD.