Presentation (CTI)

OBJECTIVES: Faster access to promising treatments for cancers with high unmet need is often not achieved due to misalignment between regulatory, Health Technology Assessment (HTA), and pricing and reimbursement (P&R) processes. There is also a fragmented approach to access pathways across countries. This research aimed to develop a pan-European framework for enabling earlier access to promising cancer therapies, outlining key principles and processes for the HTA and P&R components of an accelerated pathway.
METHODS: We developed an Accelerated Patient Access to Cancer Care in Europe (APACE) framework through a structured, multidisciplinary stakeholder engagement process. This included two surveys and roundtables with patient, regulatory, HTA, payer and industry representatives from Norway, Spain, United Kingdom, Sweden, Belgium and Italy.
RESULTS: The APACE framework proposes a conditional reimbursement model to address uncertainty for oncology treatments with high unmet need. Key components include: Eligibility Criteria: Promising treatments must address an urgent condition with significant unmet need; Initial Assessment: HTA agencies assess expected value and level of resolvable uncertainty, qualifying treatments enter managed access with a Data Collection Agreement; Reassessment: New evidence informs reassessment of value and resolution of uncertainty, leading to decisions on traditional reimbursement or delisting; Exit Phase: Outlines transition to traditional reimbursement or market removal. Stakeholders broadly supported the framework. Unresolved issues include quantifying eligibility criteria, agreeing acceptable outcomes, and selecting pricing models. Recommendations to progress implementation include defining funding arrangements and setting monitoring mechanisms at the national level, aligning evidentiary standards and enhancing real-world evidence infrastructure across countries, and exploring how the process fits into existing national and pan-European processes such as the Joint Clinical Assessment.
CONCLUSIONS: The APACE framework provides a structured, stakeholder-endorsed approach to accelerating oncology access in Europe. Further policy work is needed to resolve outstanding issues and ensure consistent implementation across countries.