FROM REAL-WORLD EVIDENCE TO SUBSIDY DECISIONS: INSIGHTS FROM HEALTH TECHNOLOGY ASSESSMENTS (HTAS) BY THE AGENCY FOR CARE EFFECTIVENESS (ACE)
Author(s)
Jian Yi Choy, MSc, Xuenan Liu, MSc, Janis Lim, BSc, Amrita Viswambaram, MSc.
Costello Medical, Singapore, Singapore.
Costello Medical, Singapore, Singapore.
OBJECTIVES: In January 2026, ACE released a position statement on the use of real-world data/evidence (RWD/RWE) to support HTA, underscoring its increasing relevance in funding decisions. This research examines how RWE is considered in HTAs in Singapore, and how it facilitates ACE’s subsidy decision-making.
METHODS: ACE appraisals published between January 2024-April 2026 were identified. Indication reviews, withdrawn appraisals and documents not reporting committee discussion were excluded. Included appraisals were reviewed for RWE’s role in HTA and influence on subsidy-recommendation.
RESULTS: Out of 54 appraisals reviewed, eight appraisals (evaluating nine regimens) incorporated RWE to estimate treatment effects where trial-based evidence was absent or insufficient. The appraisals included: non-rare cancer (3/8), rare cancer (1/8), other rare diseases (3/8), and infections (1/8). RWE comprised observational studies, long-term extensions, natural history cohorts, and post-marketing safety data. RWE was used to circumvent limitations with trials, such as lack of comparative trials (n=6), trials not reflecting local populations (n=1), small sample size (n=1), and/or insufficient long-term data (n=1). Five appraisals incorporated RWE into indirect treatment comparisons (ITCs).
Overall, 5/9 regimens received subsidy-recommendation (two on first assessment; three after price negotiations). Of these, clinical superiority was established in 3/5 regimens via ITCs, despite methodological concerns on confounding, sample size, and local applicability. Of the remaining 2/5 regimens, clinical effectiveness from trials was reinforced by RWE to establish superiority; this was despite a lack of pre-specified analysis or control arms associated with the RWE. Of the 4/9 regimens that did not receive subsidy-recommendation, reasons included: inappropriate comparator assessed in RWE-ITC, small sample size in RWE (n=10), and unfavourable pricing (unrelated to RWE).
CONCLUSIONS: In the absence of more appropriate evidence, RWE is valuable in establishing clinical effectiveness and informing HTA decision-making in Singapore. A margin of methodological limitations appears acceptable. Nonetheless, subsidy decision-making also depends on other factors, including price.
METHODS: ACE appraisals published between January 2024-April 2026 were identified. Indication reviews, withdrawn appraisals and documents not reporting committee discussion were excluded. Included appraisals were reviewed for RWE’s role in HTA and influence on subsidy-recommendation.
RESULTS: Out of 54 appraisals reviewed, eight appraisals (evaluating nine regimens) incorporated RWE to estimate treatment effects where trial-based evidence was absent or insufficient. The appraisals included: non-rare cancer (3/8), rare cancer (1/8), other rare diseases (3/8), and infections (1/8). RWE comprised observational studies, long-term extensions, natural history cohorts, and post-marketing safety data. RWE was used to circumvent limitations with trials, such as lack of comparative trials (n=6), trials not reflecting local populations (n=1), small sample size (n=1), and/or insufficient long-term data (n=1). Five appraisals incorporated RWE into indirect treatment comparisons (ITCs).
Overall, 5/9 regimens received subsidy-recommendation (two on first assessment; three after price negotiations). Of these, clinical superiority was established in 3/5 regimens via ITCs, despite methodological concerns on confounding, sample size, and local applicability. Of the remaining 2/5 regimens, clinical effectiveness from trials was reinforced by RWE to establish superiority; this was despite a lack of pre-specified analysis or control arms associated with the RWE. Of the 4/9 regimens that did not receive subsidy-recommendation, reasons included: inappropriate comparator assessed in RWE-ITC, small sample size in RWE (n=10), and unfavourable pricing (unrelated to RWE).
CONCLUSIONS: In the absence of more appropriate evidence, RWE is valuable in establishing clinical effectiveness and informing HTA decision-making in Singapore. A margin of methodological limitations appears acceptable. Nonetheless, subsidy decision-making also depends on other factors, including price.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
HTA12
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas