Factors Influencing Drug Guidance Outcomes in Singapore: A Review of 2023-2024 Appraisals
Author(s)
Chawisa Teansue, MD, Diana Beatriz Bayani, PhD, Nathaniel Henry, MSc.
Vista Health, Singapore, Singapore.
Vista Health, Singapore, Singapore.
OBJECTIVES: The Agency for Care Effectiveness (ACE) is Singapore’s health technology assessment and clinical guidance body. This study explores key factors influencing the outcomes of ACE’s drug guidance reports.
METHODS: Forty-one published drug appraisals from January 2023 to December 2024 were reviewed. All technical evaluations submitted to the Drug Advisory Committee were analysed.
RESULTS: Of the 41 appraisals, 28 (68%) were ACE-led, while 13 (32%) were company-led. Four resulted in Standard Drug List (SDL) inclusion, all ACE-led. Fourteen were listed under the Medication Assistance Fund (MAF), two of which were company-led submissions. Two drugs from company-led evaluations were listed under the Cell, Tissue, and Gene Therapy Product (CTGTP) list. The remaining 21 (51%) did not result in a subsidy. Oncology was the most common indication (37%), followed by anti-infectives (10%). Subsidised drugs generally addressed high unmet clinical needs. In multi-comparator evaluations, demonstrating superior clinical efficacy and safety was often necessary. When profiles were comparable, cost became a key determinant. In the absence of direct evidence, indirect comparisons were accepted if uncertainty was managed through pricing. Shorter time horizons, closer to the trial follow-up duration, were preferred. Incremental cost-effectiveness ratios (ICERs) for both listed and non-listed drugs ranged from S$15,000 to >S$365,000 per QALY. The mean ICER was lower for listed drugs (S$139,050) than non-listed drugs (S$176,250). Estimated first-year cost impact ranged from <S$1 million to S$10 million (mean: ~S$1.9 million) for listed drugs, versus <S$1 million to >S$20 million for non-listed drugs (mean: ~S$4.4 million).
CONCLUSIONS: For ACE-led evaluations, high unmet needs, clinical superiority, and pricing strategies that managed uncertainty were associated with listing. Conversely, higher ICERs, larger budget impact, and longer time horizons were associated with non-listing. These findings provide key considerations to inform future submissions and alignment with ACE’s decision-making framework.
METHODS: Forty-one published drug appraisals from January 2023 to December 2024 were reviewed. All technical evaluations submitted to the Drug Advisory Committee were analysed.
RESULTS: Of the 41 appraisals, 28 (68%) were ACE-led, while 13 (32%) were company-led. Four resulted in Standard Drug List (SDL) inclusion, all ACE-led. Fourteen were listed under the Medication Assistance Fund (MAF), two of which were company-led submissions. Two drugs from company-led evaluations were listed under the Cell, Tissue, and Gene Therapy Product (CTGTP) list. The remaining 21 (51%) did not result in a subsidy. Oncology was the most common indication (37%), followed by anti-infectives (10%). Subsidised drugs generally addressed high unmet clinical needs. In multi-comparator evaluations, demonstrating superior clinical efficacy and safety was often necessary. When profiles were comparable, cost became a key determinant. In the absence of direct evidence, indirect comparisons were accepted if uncertainty was managed through pricing. Shorter time horizons, closer to the trial follow-up duration, were preferred. Incremental cost-effectiveness ratios (ICERs) for both listed and non-listed drugs ranged from S$15,000 to >S$365,000 per QALY. The mean ICER was lower for listed drugs (S$139,050) than non-listed drugs (S$176,250). Estimated first-year cost impact ranged from <S$1 million to S$10 million (mean: ~S$1.9 million) for listed drugs, versus <S$1 million to >S$20 million for non-listed drugs (mean: ~S$4.4 million).
CONCLUSIONS: For ACE-led evaluations, high unmet needs, clinical superiority, and pricing strategies that managed uncertainty were associated with listing. Conversely, higher ICERs, larger budget impact, and longer time horizons were associated with non-listing. These findings provide key considerations to inform future submissions and alignment with ACE’s decision-making framework.
Conference/Value in Health Info
2025-09, ISPOR Real-World Evidence Summit 2025, Tokyo, Japan
Value in Health Regional, Volume 49S (September 2025)
Code
RWD147
Topic Subcategory
Reproducibility & Replicability
Disease
No Additional Disease & Conditions/Specialized Treatment Areas