According to recent data, nearly all Medicare prescription drug plans have limited coverage for established heart failure drugs to some degree, most often by requiring cost sharing.
Tier 3 or higher cost sharing was required for angiotensin-neprilysin receptor blocker (ARNI) therapy and at least one SGLT2 inhibitor in approximately 99% of the 4,065 Medicare Advantage plans and standalone plans in the portion D assets in the second quarter of 2020 that covered these drugs.
The only ARNI on the market, sacubitril/valsartan (Entresto), was also subject to prior authorization, as prescribed by 24.3% of drug plans. Meanwhile, step therapy was needed for SGLT2 inhibitors and the mineralocorticoid receptor antagonist (MRA) eplerenone (Inspra) in 5.4% and 0.8% of plans, respectively, Kamil Faridi reported. , MD, MSc, from the Yale School of Medicine, and colleagues from Journal of the American College of Cardiology.
Quadruple therapy for heart failure includes ARNI, SGLT2 inhibitors, ARMs, and beta-blockers. Faridi’s group estimated that out-of-pocket costs for a standard 30-day course of quadruple therapy reached a median of $94 – primarily due to the cost of ARNI ($47) and SGLT2 inhibitors ($45) – a total far exceeding the $3 cost of an all-generic drug regimen.
“Quadruple therapy may be unaffordable for many Medicare patients with HFrEF [heart failure with reduced ejection fraction] unless drug prices and cost sharing are reduced,” the authors wrote.
“In order for patients to take these drugs and receive their therapeutic benefits, they must be able to access them through their health insurance and afford the OOP handset. [out-of-pocket] costs,” they said. “This is an especially important issue for elderly patients enrolled in Medicare, who often have fixed incomes and significant expenses related to the treatment of other comorbid conditions.”
In a corresponding editorial, other cardiologists complained that cost sharing limits access to care for many patients.
“These policies likely disadvantage relatively poorer patients,” wrote Jason Wasfy, MD, MPhil, and Anna O’Kelly, MD, MPhil, both of Massachusetts General Hospital in Boston. “A reasonable approach to considering appropriate drug pricing and coverage policies is to start by making distinctions between effectiveness, efficiency, and cost-effectiveness.”
“As a general framework, cost-effectiveness analysis provides a rational basis for establishing common ground between drugmakers and insurance plans,” Wasfy and O’Kelly noted. “Without common ground, patients and clinicians are caught in the middle. This friction can discourage even cost-effective therapies and worsen disparities.”
Faridi and his colleagues estimated that for 50% of recipients, out-of-pocket expenses for quadruple therapy absorbed at least 7% of their pre-tax income. The figure jumped to 13% when looking at those in the lowest income quartile.
“Patients who pay for the Quadruple Therapy fee may be at risk of financial toxicity, characterized by the myriad of negative impacts of healthcare expenditures on patients and their families, including reduced adherence to medications, poorer mental and physical health, delay or abandonment of medical care, and food insecurity,” the authors wrote.
“Because of these findings, clinicians need to assess whether the costs of OOP are affordable or may lead to nonadherence in patients to whom ARNI and [SGLT2 inhibitors]“, they insisted.
“Greater consensus on value-based pricing could improve access to essential therapies for patients who need them,” Wasfy and O’Kelly suggested.
The study authors estimated that the majority of beneficiaries would have paid their $435 deductible in January and that OOP costs would have been offset once the coverage gap was reached around May. Once drug costs totaled $9,719, beneficiaries would have moved from the coverage gap to the catastrophic coverage phase in September.
A limitation of the study was that the authors estimated the costs of the drugs used by the participants without taking into account insurance plan premiums or the cost of other drugs.
The study was funded by an NIH grant.
Faridi has not reported any conflicts of interest.
Wasfy revealed support from the American Heart Association and NIH, consulting fees from Pfizer, fees from the Institute for Clinical and Economic Review, and chairmanship of the New England Comparative Effectiveness Public Affairs Advisory Council. O’Kelly has not reported any conflicts of interest.
Study co-authors disclosed relationships with NIH, Agency for Health Care Research and Quality, Laura and John Arnold Foundation, National Evaluation System for Health Technology Coordinating Center, Greenwall Foundation , Arnold Ventures and Johnson and Johnson.