Company-Led Submissions to the Agency for Care Effectiveness (ACE) in Singapore: What Drives Patient Access?

OBJECTIVES: Before 2021, topics for HTA in Singapore have primarily been identified through applications by public healthcare professionals. In 2021, ACE introduced a company-led submission (CLS) process for oncology drugs, enabling pharmaceutical companies to apply for HTA. This allows subsidy decisions to be made close to regulatory approval, expediting patient access. This process also enables the listing of new oncology drugs on the Cancer Drug List (CDL), whereby listed drugs are claimable from public and private insurance, and patients’ medical savings accounts. This research aims to evaluate factors influencing recommendations for subsidy and CDL listing.

METHODS: All six appraisals that underwent the CLS process and published from July 2023 to January 2024 were reviewed. TAs were reviewed to identify factors influencing ACE’s conclusions regarding clinical need, clinical effectiveness and safety, cost-effectiveness and budget impact, and their impact on the final recommendations.

RESULTS: All technologies were deemed to address a clinical need. However, the extent of clinical benefit of all technologies was considered uncertain, mainly due to immature overall survival data, and reliance on uncertain surrogate outcomes like progression-free survival. Four out of six technologies were not deemed cost-effective following ACE’s modelling revisions (e.g. shortening the time horizon; applying treatment waning), and budget impact was considered high. The remaining technologies were recommended by ACE for subsidy, and only after revised pricing proposals. All six technologies were listed on the CDL.

CONCLUSIONS: While limited by the number of published appraisals, our analysis suggests that it appears challenging for new oncology drugs to be considered cost-effective, which may in part be attributed to immature clinical evidence available, and the resulting uncertainty in models. Price reductions can increase the likelihood of a recommendation. Drugs that are unsuccessful for subsidy listing can still be listed on the CDL, which helps improve patient access through insurance coverage.