A Cost‑Effectiveness Analysis of Dapagliflozin in Heart Failure With Preserved or Mildly Reduced Ejection Fraction in Portugal

OBJECTIVES: The aim of this analysis was to assess the cost-effectiveness of dapagliflozin added to standard therapy, versus standard therapy only, in patients with heart failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF), in the Portuguese setting.

METHODS: Based on data from Dapagliflozin Evaluation to Improve the LIVEs of Patients with Preserved Ejection Fraction Heart Failure (DELIVER) trial, a lifetime Markov state-transition cohort model was developed. Quartiles of the Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS) defined health states and monthly transition count data informed transition probabilities. Multivariable generalized estimating equations captured the incidence of heart failure (HF) hospitalizations and urgent HF visits, while cardiovascular deaths and all-cause mortality were estimated using adjusted parametric survival models. Health state costs were assigned to KCCQ-TSS quartiles and patient-reported outcomes were sourced from DELIVER. A 4% annual discount was applied to all clinical outcomes and costs. Costs and healthcare resources utilization estimates were extracted from local databases and published literature. Health utilities for health states and disutilities for adverse events were sourced from DELIVER data converted to utilities based on Portuguese tariffs. Effects were measured in quality-adjusted life years (QALYs). Probabilistic and scenario analysis were used to test model assumptions and robustness.

RESULTS: Dapagliflozin was more effective than standard therapy leading to 0.20 additional QALYs (4.97 versus 4.77) per patient. Dapagliflozin was associated with incremental costs of 1,704€ (9,255€ versus 7,551€) per patient and an incremental cost-effectiveness ratio (ICER) of 8,540€/QALY. The probabilistic ICER was 8,495€/QALY and using an 20,000€/QALY willingness-to-pay threshold, 87% of simulations were cost-effective.

CONCLUSIONS: In this cost-effectiveness assessment designed for the Portuguese setting, dapagliflozin, added to standard therapy, was considered cost-effective compared with usual care for patients with HFpEF/HFmrEF. This cost-effectiveness analysis was also considered valid to support the reimbursement decision in Portugal.