OBJECTIVES: To determine the cost-effectiveness of sacubitril/valsartan compared to enalapril for the treatment of patients with chronic heart failure and reduced ejection fraction in the Portuguese context.

METHODS: A regression-based cohort model using patient-level data from a head-to-head phase III randomized clinical trial, PARADIGM-HF, was used to predict cardiovascular mortality, all-cause hospitalization and health-related quality of life. Non-cardiovascular mortality was estimated using Portuguese life tables adjusted to remove the effects of cardiovascular mortality. Portuguese-specific disease management resource use was estimated by a panel of clinical experts. National legislation and official drug cost database were the main sources for unit costs. The analysis was conducted from a societal perspective, assuming a life-time horizon and a 5% discount rate. Deterministic and probabilistic sensitivity analyses assessed the robustness of results.

RESULTS: Sacubitril/valsartan increases life expectancy by 0.9 undiscounted life-years (LY) and 0.5 discounted LY, compared with enalapril. These health gains correspond to 0.4 incremental quality adjusted life-years (QALY) versus enalapril. Treatment with sacubitril/valsartan reduces the number of hospitalisations per year by 15%. The most significant cost difference is associated with the cost of primary drug therapy. Additional costs are also accrued for background therapy and disease management associated with sacubitril/valsartan extended survival. The estimated incremental cost-effectiveness ratios (ICER) are 22,702€/QALY and 19,360€/LY. Deterministic sensitivity analysis shows that the results are robust in most scenarios, but sensitive to the parameters estimates of the cardiovascular survival curve. According to a probabilistic sensitivity analysis, 77% of the simulations resulted in an ICER <30,000€/QALY.

CONCLUSIONS: Sacubitril/valsartan is a cost-effective therapeutic option in the treatment of Portuguese patients with chronic heart failure with reduced ejection fraction translated into significant health gains and increased life expectancy versus the current standard of care.