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. 2022 Jun 28;79(25):2516-2525.
doi: 10.1016/j.jacc.2022.04.031.

Medicare Coverage and Out-of-Pocket Costs of Quadruple Drug Therapy for Heart Failure

Kamil F Faridi  1 , Elias J Dayoub  2 , Joseph S Ross  3 , Sanket S Dhruva  4 , Tariq Ahmad  5 , Nihar R Desai  5
Affiliations

Medicare Coverage and Out-of-Pocket Costs of Quadruple Drug Therapy for Heart Failure

Kamil F Faridi et al. J Am Coll Cardiol. .

Abstract

Background: Beta-blockers, angiotensin receptor-neprilysin inhibitor (ARNI), mineralocorticoid receptor antagonists, and sodium-glucose cotransporter-2 inhibitors (SGLT2i), known as quadruple therapy, are recommended for patients with heart failure with reduced ejection fraction (HFrEF).

Objectives: This study sought to determine Medicare coverage and out-of-pocket (OOP) costs of quadruple therapy and regimens excluding ARNI or SGLT2i.

Methods: This study assessed cost sharing, prior authorization, and step therapy in all 4,068 Medicare prescription drug plans in 2020. OOP costs were determined during the standard coverage period and annually based on the Medicare Part D standard benefit, inclusive of deductible, standard coverage, coverage gap, and catastrophic coverage.

Results: Tier ≥3 cost sharing was required by 99.1% of plans for ARNI and 98.5% for at least 1 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 median 30-day standard coverage OOP cost of quadruple therapy was $94 (IQR: $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).

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

Keywords: Medicare; drug costs; health insurance; heart failure.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Faridi was supported by a grant from the National Institutes of Health (NIH) Clinical and Translational Science Award (KL2 TR001862), outside the scope of the present work. Dr Ross has been supported by the National Heart, Lung, and Blood Institute of the NIH (R01HS025164, R01HL144644), by the Agency for Healthcare Research and Quality (R01HS022882), and by the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International. Dr Dhruva has been supported by the National Heart, Lung, and Blood Institute of the NIH (K12HL138046), the National Evaluation System for Health Technology Coordinating Center, the Greenwall Foundation, and Arnold Ventures. Dr Ross has received research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), and from the Agency for Healthcare Research and Quality (R01HS022882); and he has been an expert witness at the request of Relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. Dr Dhruva has received honoraria from the Institute for Clinical and Economic Review as a member of the California Technology Assessment Forum. Dr Ahmad has received research funding from AstraZeneca, Boehringer Ingelheim, Amgen, and Cytokinetics. Dr Desai has worked under contract with the Centers for Medicare and Medicaid Services to develop and maintain performance measures used for public reporting and pay for performance programs; and he has received research grants and/or been a consultant for Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, MyoKardia, Novartis, scPharmaceuticals, and Vifor Pharma. Dr Dayoub has reported that he has no relationships relevant to the contents of this paper to disclose.

Figures

FIGURE 1
FIGURE 1. Medicare Prescription Drug Plan Coverage Restrictions for Evidence-Based Medications Treating HFrEF
Coverage restrictions are reported for all Medicare Advantage and Medicare Part D Drug plans in quarter 2 of 2020. Among all plans, 36.7% did not provide any coverage for dapagliflozin, 5.1% did not provide coverage for empagliflozin, and 10.8% did not provide coverage for eplerenone. All other medication classes were covered by all plans. ARNI = angiotensin receptor-neprilysin inhibitor; HFrEF = heart failure with reduced ejection fraction.
FIGURE 2
FIGURE 2. Estimated 30-Day OOP Costs for HFrEF Medication Regimens in Medicare
All 30-day out-of-pocket (OOP) costs were based on insurance coverage during the standard coverage period for all 4,068 Medicare Advantage and Medicare Part D Drug plans in quarter 2 (calendar year) of 2020. Median (IQR) OOP costs are shown. ACEi = angiotensin-converting enzyme inhibitor; ARB = angiotensin receptor blocker; BB = β-blocker; MRA = mineralocorticoid receptor antagonist; SGLT2i = sodium-glucose cotransporter-2 inhibitor; other abbreviations as in Figure 1.
FIGURE 3
FIGURE 3. Estimated Annual OOP Costs for HFrEF Medication Regimens in Medicare
Annual OOP costs were estimated based on the 2020 Medicare Part D standard benefit inclusive of deductible, standard coverage period, coverage gap phase, and catastrophic coverage for all 4,068 Medicare Advantage and Medicare Part D Drug plans in quarter 2 (calendar year) of 2020. Median (IQR) OOP costs are shown. The annual OOP cost of BB, ACEi, and MRA was based on generic drug discount pricing. Abbreviations as in Figures 1 and 2.
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