Presentation (CTI)

Problem Statement: MR-guided focused ultrasound (MRgFUS) is a non-invasive technology approved in China (2021) for essential tremor and Parkinson’s disease. Despite regulatory approval, clinical uptake remains limited (<100 annual cases nationwide pre-2024) due to high costs (~USD 20,000) and the lack of reimbursement. Within China’s Basic Medical Insurance (BMI) system, which prioritizes coverage for basic and life-threatening conditions, reimbursement decisions follow defined coverage priorities. Technologies primarily delivering quality-of-life (QoL) improvements therefore require careful consideration within existing BMI payment frameworks. Meanwhile, Commercial Health Insurance (CHI) coverage for innovative medicines and devices remains limited, accounting for approximately 7% of innovative product payments, compared with around 44% covered by BMI. Together, high costs, evolving pricing pathways, and differentiated payer priorities highlight the need to explore alternative and sustainable payment approaches beyond BMI.
Description: This impact case applied a HEOR-oriented assessment framework to explore the potential alignment of MRgFUS with emerging CHI mechanisms in China. The analysis integrated disease burden characteristics, functional and QoL-related outcomes, and payer considerations relevant to low-volume, high-cost technologies.Evidence sources included review of regulatory and policy documents, assessment of early clinical utilization patterns, expert consultations, and analysis of recent CHI policy developments. Particular attention was given to the 2025 launch of China’s Commercial Health Insurance Innovation Medicine List, which indicated growing policy interest in expanding the role of commercial payers in supporting access to innovative medical technologies.Based on this assessment, the analysis examined alternative access approaches with relevance to CHI, including consideration of outcome-based payment concepts to address insurer concerns related to budget impact and uncertainty in real-world effectiveness. The HEOR evidence was used to inform preliminary payer-facing discussions on coverage considerations outside the BMI pathway.
Lessons Learned: For innovative medical technologies primarily delivering QoL benefits and facing barriers to BMI inclusion, CHI may represent a complementary access pathway. Early integration of HEOR principles can support payer-aligned evidence development and inform structured discussions on pricing, coverage design, and potential risk-sharing approaches, particularly for low-volume, high-cost technologies
Stakeholder Perspective: Patients gain potential access to life-changing therapies previously unaffordable due to BMI exclusions. Industry stakeholders can utilize HEOR to identify viable alternative payment channels and reduce commercial uncertainty. Payers (especially Commercial) can leverage evidence-based assessments to differentiate product offerings and manage financial risks associated with high-value medical innovations.