Sacubitril-valsartan appears cost-effective in certain heart failure patients

Treatment with sacubitril-valsartan appears to be cost-effective for reducing cardiovascular mortality and morbidity in patients with New York Heart Association (NYHA) class II to IV heart failure, a new study found.

Researchers developed a Markov model to perform an independent analysis of the cost-effectiveness of sacubitril-valsartan versus usual care in patients with a mean age of 64 years, NYHA class II to IV heart failure, and reduced ejection fraction (<0.40). Subgroup composition was based on that of the PARADIGM-HF trial, in which 72.9% of patients had class II heart failure, 26.2% had class III heart failure, and 0.9% had class IV heart failure. Patients with class I heart failure (4.7%) who were ill during screening but improved during the study's run-in phase were excluded from the Markov model but included in a sensitivity analysis. Patients in the PARADIGM-HF trial initially received sacubitril-valsartan, 200 mg twice daily, or enalapril, 10 mg daily. The current study, however, modeled lisinopril, 20 mg daily, as the comparator drug due to its lower cost, wider use, and functionally equivalent benefits. Cost-effectiveness was analyzed in subgroups of patients with class II or class III/IV heart failure. The study's outcome measures were life-years, quality-adjusted life-years (QALYs), hospitalizations for heart failure, and incremental cost-effectiveness ratios. The study results were published online Aug. 30 by Annals of Internal Medicine.

In the base-case analysis, the sacubitril-valsartan group had 0.08 fewer heart failure hospitalization, 0.69 additional life-year, 0.62 additional QALY, and $29,203 in incremental costs versus the comparator group, which equaled a cost per QALY gained of $47,053. Cost per QALY gained in sacubitril-valsartan patients was $44,531 in those with NYHA class II heart failure and $58,194 in those with NYHA class III or IV heart failure. Class I patients had a higher risk for cardiovascular death in the sacubitril-valsartan group (decrease in average survival, 0.84 year or 0.57 QALY). In the sensitivity analysis, treatment with sacubitril-valsartan was most sensitive to duration of improved outcomes; cost per QALY gained was $120,623 if duration was limited to the median duration of follow-up (i.e., 27 months). The cost per QALY gained did not exceed $100,000 for variations in any other study parameters.

The authors noted that treatment efficacy was based on a single trial with limited subgroup data and that data on long-term treatment were not available. In addition, they said that they did not model patient transition between NYHA classes, that they based drug costs on wholesale prices, and that they did not evaluate concerns about neurocognitive effects of the drug. However, they concluded that based on their analysis, sacubitril-valsartan appears to be cost-effective for reducing cardiovascular morbidity and mortality in patients with NYHA class II to IV heart failure and reduced ejection fraction. They noted that the treatment value was highest in patients with class II heart failure, who also benefited most from treatment in the PARADIGM-HF trial, and that improved outcomes with the drug would need to be sustained for at least 36 months to keep the cost per QALY below the $100,000 threshold.

ACP Hospitalistcovered sacubitril-valsartan in September 2015, soon after it gained FDA approval.