Sacubitril/valsartan well-covered, but still unaffordable for many with HFrEF

The combination heart failure drug sacubitril/valsartan is well-covered under Medicare Part D plans, according to a recent analysis, but patient access to the medication remains limited by steep out-of-pocket costs than can exceed $1,600 annually.

Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI) commonly sold under the brand name Entresto, was the first drug to show a mortality benefit for patients with heart failure with reduced ejection fraction (HFrEF) in over a decade, Colette DeJong, MD, and co-authors wrote in a research letter published in JAMA Cardiology July 10. But while the medicine is effective—it received expedited approval from the FDA in 2015 based solely on favorable results from the PARADIGM-HF trial—less than 3% of patients received it in 2016.

More than 80% of deaths from HF occur in older adults, so DeJong, of the University of California, San Francisco, and her team examined Medicare formulary and pricing files for all Part D plans in the first quarter of 2018. They excluded special needs plans, since those might have specialized formulas.

The authors analyzed coverage and 30-day cost-sharing requirements for all HFrEF patients who received guideline-directed therapy with carvedilol, furosemide and either sacubitril/valsartan or valsartan alone. In all, they covered 2,818 Part D plans across the country.

DeJong et al. found that in 2018, 100% of Medicare plans covered sacubitril/valsartan, with around 38% requiring prior authorization. Mean cost-sharing for a 30-day supply of an ARNI during the coverage period was $57—much higher than the average $2 to $5 patients paid for other examined drugs. Under a standard 2018 plan, the authors said beneficiaries receiving an ARNI, carvedilol and furosemide would pay their full $405 deductible in January and hit their coverage gap in July, at which point their monthly costs would increase to $163.

That means projected annual out-of-pocket costs for such a prescription would total $1,685, of which $1,632 would be attributable to the ARNI alone. 

“Even with new legislation capping out-of-pocket costs at 25% during the coverage gap, cost-sharing for an ARNI would exceed $100 per month,” DeJong and co-authors wrote in JAMA. “This is concerning because high out-of-pocket costs have been associated with poorer adherence and worse health outcomes among patients with cardiovascular disease.”

Compared to patients prescribed an ARNI, Medicare beneficiaries who were receiving an angiotensin II receptor blocker (ARB) alongside carvedilol and furosemide would have projected annual costs of $291 and likely wouldn’t hit their deductible before the end of the year.

In an editor’s note connected to the study, Gregg C. Fonarow, MD, and fellow JAMA editors called DeJong et al.’s findings “sobering.” They said Medicare patients already often face higher copays than those with commercial insurance, and even with changes being made in 2019, out-of-pocket costs of HFrEF patients receiving sacubitril/valsartan will remain high.

“Optimal use of ARNI in HFrEF improves health status, increases survival and has been projected to prevent 28,484 deaths per year, which would represent a 10% reduction in total annual heart failure deaths in the United States,” Fonarow and colleagues wrote. “This under-recognized and substantial out-of-pocket patient expense burden among those with Medicare Part D coverage represents a significant impediment to wider use and improved population health. Thus, it is important that we continue to seek novel solutions to improve access to life-enhancing therapies.”