OBJECTIVES: Empagliflozin, the only SGLT2i in the MOH Medicines Formulary for type 2 diabetes mellitus, is limited to treating patients in hospital settings. Stakeholders propose widening access to empagliflozin in primary care settings, or using dapagliflozin or luseogliflozin as alternatives for ≥1 indications in hospitals or primary care. Therefore, this study aimed to conduct an inherently complex BIA for this multiple HTA to estimate the financial consequences of implementing any one or combination of these scenarios.

METHODS: Three budget impact models were developed using Microsoft® Excel for a five-year time horizon. Each model was differentiated by prescribing indications, restrictions, and SGLT2i involved (M1: glycemic control, HbA1c>6.5%-10%, empagliflozin-dapagliflozin-luseogliflozin; M2: cardiovascular benefits, HbA1c<10%, empagliflozin-dapagliflozin; M3: an M1/M2 composite). The target population was estimated using local data sources, with current interventions defined by the formulary. Future market effects were defined by multiple uptake scenarios modeled upon the combination of ≥1 SGLT2i (and any ≥1 indication in M3) and use setting. Drug prices were proposed by dossier applicants, and other relevant costs were estimated using local data sources (US$, 2022). The outcome was expressed as net budget impact (NBI), calculated by subtracting current scenario’s total cost from future scenarios’ total costs.

RESULTS: A total of 70 uptake scenarios were modeled to simulate all possible combinations, including the impact of dapagliflozin’s volume-based pricing. Among the scenarios modeled, those that added ≥1 alternative but restricted to hospital-only settings yielded the lowest NBI in all models (M1: $0.94mil; M2: $1.08mil; M3: $1.36mil). Should access to primary care be expanded, adding dapagliflozin for use in hospital and primary care settings while maintaining empagliflozin in hospital-only settings would yield the lowest NBI ($4.12mil; for both indications in M3).

CONCLUSIONS: Though complex and time-consuming, the simulation of a wide range of practical uptake scenarios has enabled this comprehensive BIA as a useful decision-making aid.