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Lack of insurance coverage is not the issue with sacubitril/valsartan (Entresto) for many older people in the U.S. -- it's the high cost, a study suggested.

Under a standard Medicare Part D plan, patients with heart failure with reduced ejection fraction (HFrEF) getting guideline-directed therapy with carvedilol (Coreg), furosemide (Lasix), and angiotensin receptor-neprilysin inhibitor (ARNI) therapy with sacubitril/valsartan would:

• Hit their $405 deductible in January
• Pay $57 monthly out-of-pocket under standard coverage until they face the "donut hole" in July
• Pay $163 per month in cost-sharing thereafter

In all, the projected annual out-of-pocket cost of these medications was estimated to $1,685, of which $1,632 was for the ARNI alone, according to a research team led by Colette DeJong, MD, of the University of California San Francisco, reporting their findings online in .

In contrast, HFrEF patients getting an angiotensin II receptor blocker (ARB) like valsartan on top of carvedilol and furosemide would pay $291 per year and not meet their deductible.

"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. This is concerning because high out-of-pocket costs have been associated with poorer adherence and worse health outcomes among patients with cardiovascular disease," the authors wrote.

"The findings are sobering," commented Gregg Fonarow, MD, of the UCLA Medical Center, and two other JAMA Cardiology editors in an accompanying note. "This underrecognized 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. These circumstances also affect Medicare beneficiaries receiving many other evidence-based prescription medications."

Without addressing the issue of out-of-pocket expenses, disparities in care quality and outcomes will widen further, the editors said.

Cost clearly has an impact on prescription rates, but physician inertia is another issue, according to Thomas Gaziano, MD, of Brigham and Women's Hospital in Boston, who cited the delay of 10 to 15 years it typically takes from a positive trial for a drug to appear in guidelines.

PARADIGM-HF was the landmark 2014 trial that showed that sacubitril/valsartan decreased hospitalizations and deaths in HFrEF. Novartis won expedited FDA approval for the compound in 2015.

"Despite these considerable benefits and a class I guideline recommendation to replace angiotensin-converting enzyme inhibitor or angiotensin receptor antagonist therapy with ARNI therapy in patients who remain symptomatic, in clinical practice has been sluggish," Fonarow and colleagues wrote.

Indeed, a 2016 study found that of HFrEF patients got on ARNI therapy in the first 18 months after FDA approval.

However, that was before the release of the 2016 guideline from the American College of Cardiology, American Heart Association, and Heart Failure Society of America. Uptake of sacubitril/valsartan has probably gone up since then, Gaziano said.

DeJong and colleagues based their study on public Medicare formulary data and pricing files from the first quarter of 2018. Costs were averaged across all Part D plans by county and state.

The investigators identified 2,818 plans, all of which covered sacubitril/valsartan (albeit with 38% requiring prior authorization).

A 30-day ARNI supply costs Medicare beneficiaries an average of $57. Valsartan, carvedilol, and furosemide each cost around $2 to $5.

One limitation of the study was that it didn't consider costs of other prescription drugs.

"Although generic pricing of heart failure medications can , the burden of added cost associated with sacubitril-valsartan may be prohibitive for the majority of patients on fixed or limited incomes," commented Paul Hauptman, MD, of the University of Tennessee Graduate School of Medicine in Knoxville.

"How this ultimately impacts prescription patterns, adherence and downstream clinical outcomes is not yet clear, but for a drug that received expedited approval and rapid incorporation into practice guidelines, the gap between what should be done and what can be done for patients is predictably stark," Hauptman told 木瓜直播.