Introduction
An EU-focused PICOS (population, intervention, comparator, outcomes or study-type) framework may be insufficient for global HTA evidence generation, as it may not reflect differences in treatment landscapes, reimbursement conditions, or evidence
requirements across markets.
APAC decision-making is informed by country-specific standards of care, affordability constraints, treatment sequencing, and local treatment reimbursement and adoption. Consequently, evidence generated based on EU-relevant PICOS may have limited transferability to APAC HTA and reimbursement contexts.
Authors: Latour, A; Chanda, V
Objectives
This analysis aims to evaluate the extent to which PICOS-related issues were a primary driver of suboptimal HTA outcomes, including rejection, deferral, restriction, or price impact.
HTA precedents were used to assess how misalignment between EU-focused PICOS domains and APAC evidence requirements may affect access and pricing opportunities.
Methods
A targeted literature review of HTA reports and grey literature between 2020 and 2026 was conducted across Japan, S. Korea, Australia, New Zealand, Taiwan and Singapore, to identify HTA precedents where PICOS-related issues were the primary driver of rejection, deferral, restriction or price impact
Findings were mapped to PICOS domains and pre-defined sub-domains. Primary drivers were selected and qualitatively interpreted to identify APAC-specific evidence and access risks that may not be captured by an EU JCA-focused evidence strategy
Conclusion
Our analysis suggests that PICOS misalignment may directly influence APAC HTA outcomes, with PICOS issues resulting in rejection, deferral, restriction, or price reduction. However, the analysis was exploratory and hypothesis-generating; the small sample size and absence of a comparator set of positive HTA outcomes limited the ability to demonstrate a causal association between PICOS misalignment and suboptimal HTA outcomes. Further research should include a full systematic literature review and controlled analysis comparing positive and suboptimal HTA outcomes to quantify the relative contribution of PICOS-related factors to reimbursement decisions across APAC markets.