OBJECTIVES:

For products indicated for chronic heart failure with reduced ejective fraction (HFrEF) half-cycle correction might be of increased importance to capture effect of survival gains and reduction in hospitalizations. To understand the importance and effect of half-cycle correction in cost-effectiveness analysis for Sacubitril/Valsartan vs Enalapril in HFrEF.

METHODS:

We developed a Markov model that captures mortality and heart failure (HF) and non-HF hospitalizations. US patients with HFrEF similar to those in the PARADIGM-HF trial were included in the model. Risks of all-cause mortality and hospitalization from HF or other reasons were estimated with a 30-year time horizon. Quality of life was based on trial EQ-5D scores. A discount rate of 3% was used. Two scenarios, with and without half-cycle correction were tested.

RESULTS: For the model without half-cycle correction, the undiscounted life years (LYs) for Sacubitril/Valsartan and Enalapril were, 11.27 and 9.77 years, respectively, an increase of 1.46 years (similar to 1.43 years reported in Gaziano 2016 model). Applying the half-cycle correction, the undiscounted LYs for Sacubitril/Valsartan and Enalapril were, 11.23 and 9.73 years, respectively, an increase of 1.50 years. Half-cycle increased the estimates for incremental undiscounted LYs by 3.3%. Similarly, for the model without half-cycle correction, the discounted QALYs for Sacubitril/Valsartan and Enalapril were, 7.16 and 6.36 QALYs, respectively, an increase of 0.79 QALYs (similar to QALYs Gaziano 2016 and ICER 2016 model). Applying the half-cycle correction, the discounted QALYs for Sacubitril/Valsartan and Enalapril were, 7.28 and 6.39 QALYs, respectively, an increase of 0.88 QALYs. Half-cycle increased the estimates for incremental QALYs by 11%.

CONCLUSIONS: For products with long-term incremental gains, half-cycle correction might potentially capture more treatment benefits. Case study of Sacubitril/Valsartan vs Enalapril Heart Failure with Reduced Ejection Fraction shows near 11% impact of incremental QALYs