The era of the US and Europe dominating evidence generation decision-making is fading. Instead, success increasingly depends on cross-geography collaboration and a strategic approach to where high-quality evidence can be generated quickly and compliantly. Organisations that fail to adapt risk falling behind.
One issue panel at this year’s ISPOR highlighted China’s emergence as a strategic hub for evidence generation.1 Historically, evidence generated in China primarily supported domestic decisions (“in China for China”), but rapid advances in R&D, innovation and investment are driving a shift toward “in China for ex-China”, especially in a world where policy changes risk stifling innovation in other regions (see MFN Through the Lens of Dynamic Efficiency article).
While challenges remain in aligning evidence standards with global expectations, China’s potential for lower-cost, faster study execution creates opportunities. Rare diseases are a particularly promising case for testing this theory, given well-known challenges in generating high quality evidence. Specifically, rapid conduct of rare disease trials and natural history studies could facilitate not only access in China, but also ex-China, if careful consideration to generalisability is proactively taken. This also has implications for those of us working on value materials for payer audiences where generalisability is key. We need to go beyond weak claims, to an evidence-based approach where the patient population of a clinical trial has been shown to be relevant in the real world and that this is considered prior to evidence generation, rather than at the time of value/reimbursement material development.
Another ISPOR 2026 session focused on a comparison of real-world evidence (RWE) in support of local reimbursement decisions across the US and China. It drew a comparison between studies in support of CMS-led drug pricing negotiations in the US and the recent policy from 2025 linking RWE to decision making for the National Reimbursement Drug List (NRDL) in China.2
The timing of evidence generation within a product’s lifecycle may differ, with evidence for the Chinese setting needed at the time of launch (and two years thereafter for renegotiation) vs many years after initial approval in the US at the point of selection for CMS-led negotiations. However, the need to coordinate generation of the right evidence at the right time, against the right comparators, using robust and independent data sources, and specific to the patient population of interest, remains consistent.
Companies that have compelling evidence ready at the right time not only improve their chances of being reimbursed at all, but of being reimbursed more quickly, at a better price, and for longer. Here also lies an opportunity for cross-geographical learning – if US and China teams closely collaborate, US data packages may benefit from iterating on earlier evidence generation approaches and framing of value to ultimately improve reimbursement outcomes.
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If you would like any further information on the summary presented above, please get in touch, or visit our Evidence Development page to learn how our expertise can benefit you. Molly Atkinson (US Head of Value & Access) created this article on behalf of Costello Medical. The views/opinions expressed are their own and do not necessarily reflect those of Costello Medical’s clients or affiliated partners.
