Across the Asia‑Pacific, patient involvement in regulatory and HTA processes is expanding, but approaches vary. Rare diseases and precision medicines amplify evidence uncertainty, highlighting the need for structured, meaningful patient involvement.
This multi-stakeholder workshop explored practical steps for embedding meaningful PE and PED in regulatory and HTA processes in the Asia-Pacific region.
Background
Integrating patient perspectives into the development, regulation, and health technology assessment (HTA) of new medicines is increasingly vital to ensuring decisions reflect patient needs and values. In October 2025, CIRS convened a multi-stakeholder workshop that emphasised the need for supportive policies, greater transparency in decision making, and alignment between regulatory and HTA bodies to embed patient engagement (PE) and patient experience data (PED) effectively.
While healthcare systems in the Asia-Pacific are rapidly evolving, the use of PE and PED in regulatory and HTA processes remains nascent in many countries. Challenges persist such as limited infrastructure, fragmented data sources, small patient populations, cultural and linguistic barriers, and operational complexity in multi-stakeholder collaboration. Addressing these issues is essential to ensure meaningful PE and PED and equitable access to innovative therapies.
The growth of rare disease and precision medicines has emphasised the need for integrated PE and PED in regulatory and HTA decision making. In such cases, patient and caregiver experiences provide critical context to understand unmet need, acceptability of treatment options, and the real‑world implications of disease burden.
Recognising these developments, CIRS, in collaboration with the Duke NUS Centre of Regulatory Excellence (CoRE) in Singapore, convened this workshop to bring together regulators, HTA agencies, patient organisations, academics, and industry representatives from across the Asia-Pacific. The objectives were to:
- Identify current practices and challenges in patient involvement across Asia‑Pacific HTA and regulatory systems.
- Explore strategies for building capacity among patient organisations and agencies to incorporate PED in regulatory and HTA processes.
- Examine the role of PE and PED in the evaluation of rare diseases and precision medicines.
- Develop practical recommendations to support sustainable and meaningful patient involvement aligned with local health system priorities and economic contexts.
