New Haven, CT—Quadruple therapy has become unaffordable for many patients with heart failure with reduced ejection fraction (HFrEF), and the problem will persist unless something is done about medication prices and cost-sharing, a new study warns.

Quadruple therapy consisting of beta-blockers (BBs), angiotensin receptor-neprilysin inhibitors (ARNIs), mineralocorticoid receptor antagonists (MRAs), and sodium-glucose cotransporter-2 inhibitors (SGLT2is) is recommended for patients with HFrEF. In April, guidelines from the Journal of the American College of Cardiology and the American Heart Association embraced the use of these four drug classes for specific patients.

The study, led by Yale School of Medicine researchers, sought to determine Medicare coverage and out-of-pocket (OOP) costs of quadruple therapy and regimens excluding ARNI or SGLT2i.

To do that, the researchers assessed cost-sharing, prior authorization, and step therapy in all 4,068 Medicare prescription drug plans in 2020. They determined OOP costs during the standard coverage period and annually based on the Medicare Part D standard benefit, including deductible, standard coverage, coverage gap, and catastrophic coverage.

Results indicate that tier 3 or higher cost-sharing was required by 99.1% of plans for ARNI and 98.5% for at least one SGLT2i. "Only ARNI required prior authorization (24.3% of plans), and step therapy was required only for SGLT2is (5.4%) and eplerenone (0.8%)," the authors noted.

The study advised that:

• The median 30-day standard coverage OOP cost of quadruple therapy was $94 (IQR [interquartile range]: $84-$100), including $47 (IQR: $40-$47) for ARNI and $45 (IQR: $40-$47) for SGLT2i.
• The median annual OOP cost of quadruple therapy was $2,217 (IQR: $1,956-$2,579), compared with $1,319 (IQR: $1,067-$1,675) when excluding SGLT2i and $1,322 (IQR: $1,025-$1,588) when including SGLT2i and substituting an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for ARNI.
• The median 30-day OOP cost of generic regimens was $3 (IQR: $0-$9).

"Medicare drug plans restrict coverage of quadruple therapy through cost-sharing, with OOP costs that are substantially higher than generic regimens," the researchers concluded. "Quadruple therapy may be unaffordable for many Medicare patients with HFrEF unless medication prices and cost-sharing are reduced."

The study added that nearly all Medicare prescription drug plans in 2020 provided coverage for quadruple therapy consisting of BBs, ARNIs, MRAs, and SGLT2is for treatment of HFrEF. "However, coverage was restricted primarily through cost-sharing and estimated annual OOP costs for beneficiaries were >$2000 per year under most plans. OOP costs for regimens with ARNI and SGLT2is were significantly higher than generic regimens," the authors wrote.

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