Leveraging managed access with life-cycle reassessment in Asia-Pacific: advancing the learning of health system matters for innovative medicines in oncology

Publication Date
2025-12-01
Journal
The Lancet Regional Health Western Pacific
Author(s)
Yuanshi Jiao; Zonglin Dai; Jiangnan Zhu; Manuel A. Espinoza; Xue Li
Abstract
The acceleration of oncology drug research and development (R&D) and approvals over the past decade marks a watershed moment for patients and the pharmaceutical industry worldwide. Several uncertainties, often neglected, created by expedited approvals make it crucial to establish a learning health system that can leverage the initial reimbursement decisions to post-marketing lifecycle reassessment of the safety, effectiveness and cost-effectiveness of anti-cancer drugs, so-called lifecycle health technology assessment (HTA). The lifecycle HTA framework aligns assessment with a technology's entire life span to balance three goals: timely patient access, payer sustainability, and sponsor certainty. It typically begins with managed access to innovation, characterised by iterative evidence updates over time, culminating in evidence-based pricing and reimbursement decisions. In this comment, we argue that adopting a lifecycle HTA approach in Asia-Pacific is both urgent and strategic, given the global contribution of this region to pharmacological innovation. To support this effort, we propose a roadmap to facilitate implementation.