Cost-effectiveness of sacubitril/valsartan increases at lower ranges of LVEF
Key takeaways:
- The cost-effectiveness of sacubitril/valsartan was intermediate in patients with HF with mildly reduced EF.
- The angiotensin receptor/neprilysin inhibitor was more cost-effective in patients with lower EF.
Researchers reported that sacubitril/valsartan was more cost-effective for patients with HF and reduced left ventricular ejection fraction vs. those with HF with mildly reduced EF, for whom it was of intermediate value.
An updated cost-effectiveness analysis of the angiotensin receptor/neprilysin inhibitor sacubitril/valsartan (Entresto, Novartis) using data from the PARADIGM-HF and PARAGON-HF trials and a large U.S. registry was published in JAMA Cardiology.
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“Updated and comprehensive economic valuation of sacubitril/valsartan among a broader group of patients with HF inclusive of higher EFs is important to guide value assessments and payer coverage decisions,” Ankeet S. Bhatt, MD, MBA, ScM, clinical fellow in the division of cardiology at Brigham and Women’s Hospital and Harvard Medical School, and colleagues wrote. “Prespecified, participant-level pooled data from the complementary PARADIGM-HF and PARAGON-HF trials allow for the evaluation of health benefits of sacubitril/valsartan vs. renin-angiotensin system inhibitors (RASis) across various ranges of EF. We leveraged these data to examine the cost-effectiveness of sacubitril/valsartan vs. RASis among a broader range of EFs and at different upper-level cutoffs defining below-normal EF.”
PARADIGM-HF was a double-blind randomized trial for which researchers evaluated the effects of sacubitril/valsartan compared with enalapril in 8,442 patients with HF reduced EF and NYHA class II to IV.
For the PARAGON-HF trial, researchers assessed the effects of sacubitril/valsartan compared with valsartan in 4,822 patients aged 50 years or older with HF preserved EF and NYHA class II to IV.
As Healio previously reported, in PARADIGM-HF, sacubitril/valsartan was superior compared with enalapril for the reduction of death and HF hospitalization in patients with HFrEF. However, sacubitril/valsartan did not significantly reduce the rate of hospitalizations for CV death and HF in patients with HFpEF enrolled in the PARAGON-HF trial.
Using data from the two trials, Bhatt and colleagues created a five-state Markov model to estimate the cost-effectiveness of sacubitril/valsartan compared with RAS inhibition when considering all-cause mortality, HF hospitalization and quality of life.
Treatment effects were generated in 5% EF increments up to 60% and applied to a distribution of 13,264 U.S. patients from the Get With the Guidelines-Heart Failure registry.
ICER for sacubitril/valsartan at varying LVEFs
The wholesale cost of sacubitril/valsartan was $7,092 per year, according to the study.
Among patients with EF of 60% or less, sacubitril/valsartan was estimated to add 0.53 quality-adjusted life-years (QALYs) at an incremental lifetime cost of $40,892 compared with RAS inhibition, conferring an incremental cost-effectiveness ratio (ICER) of $76,852 per QALY, according to the study.
The researchers projected that 95% of the values of the ICER occurred between $71,516 and $82,970 per QALY.
In patients with chronic HF and EF of 60% or less, sacubitril/valsartan would be of intermediate value — defined as an ICER less than $180,000 per QALY — at a cost of $10,242 or less per year, compared with RAS inhibition, and of high economic value — ICER less than $60,000 per QALY — at a cost of $3,673 or less per year.
Sacubitril/valsartan was cost-saving in patients with chronic HF and EF of 60% or less at a price of $338 or less per year, according to the study.
The ICERs for sacubitril/valsartan were $67,331 per QALY for patients with EF of 55% or less; $59,614 per QALY for patients with EF of 50% or less; and $56,786 per QALY for patients with EF of 45% or less.
Moreover, sacubitril/valsartan was shown to be more cost-effective among patients in the lower EF range, with an ICER of $100,388 per QALY gained among those with EFs between 45% and 55% and an ICER of $84,291 per QALY gained among those with EFs between 45% and 50%, according to the study.
Sacubitril/valsartan more cost-effective at lower EF cutoffs
“We found that the cost-effectiveness of sacubitril-valsartan for patients with HF with an EF of 60% or less was at least of intermediate value and was highly sensitive to drug costs,” the researchers wrote. “Treatment with sacubitril/valsartan vs RASis was more cost-effective at lower EF cutoffs and of high economic value in a broad range of patients with HFrEF or [HF mildly reduced EF].
“Reductions in the cost of sacubitril-valsartan would improve the value of this therapy; therefore, this evaluation may represent a conservative assessment of its cost-effectiveness,” the researchers wrote. “In addition, we assessed the effects of treatment with sacubitril/valsartan on HF and mortality endpoints alone; however, this therapy has also been associated with numerical reductions in adverse kidney effects, estimated glomerular filtration rate declines, and less progression to end-stage kidney disease. Modeling of these additional endpoints may further improve the value of this therapy.”
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