Treatment with the angiotensin receptor-neprilysin inhibitor (ARNI) sacubitril/valsartan (Entresto, Novartis) is as cost-effective as other high-value and accepted cardiovascular interventions used in practice today, and its use should be optimized in the setting of heart failure with reduced ejection fraction (HFrEF), a new analysis of the PARADIGM-HF trial suggests[1].
"Not only do patients who take sacubitril/valsartan live longer, they actually have a better quality of life because they are hospitalized less," Dr Thomas Gaziano (Brigham and Women's Hospital, Boston, MA) told heartwire from Medscape.
"So, if our society accepts defibrillators or stenting in acute coronary syndromes or myocardial infarction as being cost-effective, we should accept this treatment too—it's consistent with a lot of other things we do in medicine and that's the argument we are making," said Gaziano, lead author of the study published June 22, 2016 in JAMA Cardiology.
Commenting to heartwire , Dr Harlan Krumholz (Yale University, New Haven, CT) said the results of the PARADIGM-HF trial were "impressive and encouraging."
"The question is whether we need further evidence before proclaiming how many lives [ARNI therapy] can save," he added in an email. "These modeling studies provide a perspective, assuming PARADIGM-HF results stand up over time."
But Krumholz, who isn't connected with PARADIGM-HF, cautioned that—as is well recognized—first studies are sometimes contradicted by later ones, or at least the treatment may be seen to have weaker effects in subsequent studies.
Cost-Effectiveness Model
Gaziano and colleagues developed a model simulating heart failure for the US population using PARADIGM-HF data. In the trial, cardiovascular outcomes were compared between patients with an LVEF of 40% or less and NYHA heart failure class 2–4.
At an average follow-up of 27 months, patients randomized to sacubitril/valsartan had approximately 20% fewer hospitalizations and about a 16% lower risk of all-cause mortality than those randomized to enalapril.
Costs analyzed in the group's model included medications and the downstream need to hospitalize some of the patients. Hospital costs included the combined rates from Medicare and private insurance.
Gaziano and colleagues predicted that 17.1% of patients on sacubitril/valsartan would have died by 29 months compared with 19.9% of patients on enalapril, very similar to the percentages of patients in the PARADIGM-HF trial who died at a mean follow-up of 27 months.
"In a given year, 1000 patients receiving sacubitril/valsartan would cost approximately $4.4 million more in differential drug costs. In the same year, the reductions in hospitalizations would lead to a savings of $1.3 million compared with patients receiving enalapril," the group writes.
Over an average life expectancy, the cost per patient would be $118,500 for each individuals treated with ARNI therapy compared with $83,300 per patient treated with enalapril. This suggests that patients or at least governments would pay about $35,000 more if they were prescribed ARNI therapy compared with enalapril, according to the group.
"However, this goes back to the 'willingness-to-pay threshold,' because those taking sacubitril/valsartan will also live an additional 1.3 years longer than those taking enalapril, and that works out to about $45,000 for each additional quality-adjusted life-year [QALY] gained," Gaziano explained.
"And this is well below the lowest threshold of $50,000 QALY set by most societies and which is commonly considered acceptable."
ARNI-Eligible Patients
As Gaziano and colleagues point out, about half of some 5.7 million patients in the US have HFrEF and would be eligible for ARNI therapy. This means that ARNI therapy could potentially reduce hospitalizations for heart failure by approximately 3000 for every 100,000 patients treated with sacubitril/valsartan over a 2-year interval.
The same strategy would reduce deaths "by nearly the same number," the group adds. Thus, "medical savings from reduced heart-failure admissions would be more than $27 million," Gaziano noted.
Meanwhile, a separate analysis of the PARADIGM-HF trial by Dr Gregg Fonarow (University of California, Los Angeles) and colleagues showed that a sizable number of deaths in the US could be prevented by optimizing ARNI uptake in heart-failure patients who can take the drug[2].
As Fonarow and colleagues note, application of results from the PARADIGM-HF trial to candidate heart-failure patients in the US suggests that optimal implementation of ARNI therapy could prevent 28,484 deaths each year.
"What Fonarow and colleagues asked was, if everybody gets treated with sacubitril/valsartan, what is the maximal potential we have to gain if we optimized uptake?" Gaziano observed. "And the numbers they arrived at are consistent with ours. They just scaled it up to the whole US population."
PARADIGM HF was funded by Novartis. Gaziano reports receiving grant support from Novartis to Brigham and Women's Hospital; disclosures for the coauthors are listed in the article. Fonarow reports receiving consulting fees from Amgen, Janssen, Medtronic, and Novartis ; disclosures for the coauthors are listed in the article. Krumholz is chair of a scientific advisory committee for UnitedHealthcare.
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Heartwire from Medscape © 2016 Medscape, LLC
Cite this: Sacubitril/Valsartan Is Cost-effective in Low-EF Heart Failure: Analysis - Medscape - Jun 27, 2016.
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