BEYOND EU JCA: THE VALUE OF EARLY AND GLOBAL PICOS MAPPING TO MARKET ACCESS OF INNOVATIVE MEDICINES IN APAC MARKETS
Author(s)
Andrea Latour, MSc1, Vishal Chanda, MSc2.
1Remap Consulting, Zug, Switzerland, 2Remap Consulting UK Ltd, Zug, Switzerland.
1Remap Consulting, Zug, Switzerland, 2Remap Consulting UK Ltd, Zug, Switzerland.
OBJECTIVES: Joint Clinical Assessment (JCA) has increased focus on prospective PICOS definition in Europe; however, innovative medicines seeking access in Asia-Pacific (APAC) markets must also satisfy locally specific evidence expectations. This analysis explored whether early global PICOS mapping could address APAC reimbursement risks.
METHODS: A targeted review of HTA reports and grey literature between 2020 and 2026 was conducted across Japan, S. Korea, Australia, New Zealand, Taiwan and Singapore, for precedents where PICOS (population, intervention, comparator, outcomes or study type) issues were the primary driver of rejection, deferral, restriction or price impact. Findings were mapped to PICOS domains and pre-defined sub-domains, and qualitatively interpreted to identify APAC-specific evidence and access risks that may not be captured by an EU JCA-focused evidence strategy.
RESULTS: Fifteen APAC precedents were identified with the primary PICOS drivers being population (3/15), intervention (2/15), comparator (5/15), outcome measure (3/15) and study type (2/15). Population PICO subdomains included clinical trial population and population clarity, resulting in rejection, deferral, and recommendation with population restrictions. Intervention subdomains of treatment line and treatment duration led to recommendation with line of therapy restriction and recommendation conditional to evidence development, respectively. Comparator was the most frequent domain associated with issues, with the most frequent sub-domain being local standard of care misalignment in 3/5 comparator precedents, resulting in rejection, recommendation with line of therapy restriction, and recommendation with price reduction. Outcome measure issues included surrogate endpoints in 2/3 and country-level utilities in 1/3 precedents, resulting in deferral, rejection, and recommendation pending local-level data. Study-type issues comprised one single-arm trial rejection and one deferral due to immature-evidence.
CONCLUSIONS: PICOS misalignment directly influences APAC HTA outcomes. Our analysis suggests that PICOS assessment should be conducted early, ideally at the trial-design stage, and incorporate comprehensive country-level considerations to anticipate evidence gaps and optimise market access strategy.
METHODS: A targeted review of HTA reports and grey literature between 2020 and 2026 was conducted across Japan, S. Korea, Australia, New Zealand, Taiwan and Singapore, for precedents where PICOS (population, intervention, comparator, outcomes or study type) issues were the primary driver of rejection, deferral, restriction or price impact. Findings were mapped to PICOS domains and pre-defined sub-domains, and qualitatively interpreted to identify APAC-specific evidence and access risks that may not be captured by an EU JCA-focused evidence strategy.
RESULTS: Fifteen APAC precedents were identified with the primary PICOS drivers being population (3/15), intervention (2/15), comparator (5/15), outcome measure (3/15) and study type (2/15). Population PICO subdomains included clinical trial population and population clarity, resulting in rejection, deferral, and recommendation with population restrictions. Intervention subdomains of treatment line and treatment duration led to recommendation with line of therapy restriction and recommendation conditional to evidence development, respectively. Comparator was the most frequent domain associated with issues, with the most frequent sub-domain being local standard of care misalignment in 3/5 comparator precedents, resulting in rejection, recommendation with line of therapy restriction, and recommendation with price reduction. Outcome measure issues included surrogate endpoints in 2/3 and country-level utilities in 1/3 precedents, resulting in deferral, rejection, and recommendation pending local-level data. Study-type issues comprised one single-arm trial rejection and one deferral due to immature-evidence.
CONCLUSIONS: PICOS misalignment directly influences APAC HTA outcomes. Our analysis suggests that PICOS assessment should be conducted early, ideally at the trial-design stage, and incorporate comprehensive country-level considerations to anticipate evidence gaps and optimise market access strategy.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
HTA11
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas