In the US, HF Prevalence—and Costs—Rising Steeply: HFSA Report

The economic burden of caring for patients with heart failure (HF) in the United States is substantial, and these costs are expected to rise as the population gets older, according to a new report from the Heart Failure Society of America (HFSA).

By 2030, it is estimated that more than 8 million Americans will have heart failure, or one in every 33 adults, with the associated costs of care expected to be at least $70 billion per year. That would translate into $244 for every US adult to care for patients with HF.

Today, the annual cost of caring for a single patient with HF is close to $30,000.

“Heart failure is a growing condition,” Haider J. Warraich, MD (Brigham and Women’s Hospital/VA Boston Healthcare System, MA), senior author of the new report, told TCTMD. “As physicians and clinicians, we focus a lot on the morbidity and mortality of the condition. But I think we also realize that this is a condition that really has a very, very broad footprint and that includes a very significant economic footprint, as well, not just on our health system and payers but also on patients themselves.”

High Co-pays, High Deductibles

In terms of societal costs, the biggest burden related to HF stems from hospitalizations and rehospitalizations, with as much as 80% of the direct costs attributable to inpatient stays. In 2016, there were more than 800,000 patients discharged from hospital with a primary HF diagnosis and approximately 2 to 3 million more patients discharged with HF as a secondary diagnosis. HF is the second-most-common inpatient diagnosis billed to Medicare and carries with it one of the highest 30-day readmission rates.

While there has been a decline in the length of the hospital stay in recent years, the cost per hospitalization has increased to $19,000 (in 2016 USD). This increase is likely the result of more procedures, as well as sicker patients coming to hospital.

In 2016, there were nearly 2 million office visits for HF and more than 410,000 emergency department visits with a primary HF diagnosis. Like other conditions, the COVID-19 pandemic likely had an effect on the number of office and hospital visits in the US. Data from other countries has shown that hospitalizations were down by as much as 40% during the initial phase of the pandemic. 

The HFSA-sponsored review, which was published this week in the Journal of Cardiac Failure and includes Paul Heidenreich, MD (Stanford University School of Medicine, CA), as lead author, provides a detailed look at the full implications of HF, including a snapshot of the cost-effectiveness of various treatments. Many of the medications making up the pillars of HF treatment—ACE inhibitors, beta-blockers, and mineralocorticoid receptor antagonists (MRAs)—are generic, inexpensive, and cost-effective.

Beta-blockers, ACE inhibitors, and ARBs all provide high-value care, while MRAs also meet the threshold for high value if the cost per quality-adjusted life-year (QALY) gained is set at less than $65,000 (as per the World Health Organization, which sets the threshold of value by factoring in the country’s wealth, or gross domestic product). Ivabradine, which is still under patent protection, has a lone, industry-sponsored cost-effectiveness analysis suggesting it, too, is a high-value agent.

Other medications, such as the new sodium glucose cotransporter 2 (SGLT2) inhibitors and sacubitril-valsartan (Entresto; Novartis), vary in value. To date, there’s been just one economic analysis with SGLT2 inhibitors, dapagliflozin (Farxiga; AstraZeneca), with investigators reporting an overall cost per QALY of $83,650, which the American College of Cardiology and American Heart Association consider “intermediate” value. On the other hand, several analyses from the PARADIGM-HF trial, as well as PIONEER-HF, have shown sacubitril/valsartan to provide high-value care. Yet these newer drugs are often unaffordable for many patients because of large co-pays and deductibles.

“These medications do come with a sizeable out-of-pocket cost,” said Warraich. “Sometimes it can be in the hundreds of dollars per month.”

For older patients, most of whom have multiple comorbidities, these costs can be a real problem, he added. While co-pays and deductibles are meant to reduce inappropriate use of medical therapy by asking patients to bear some of the cost, this can limit the affordability of treatment, particularly for new drugs. Manufacturers also need to reckon with how these drugs are priced, particularly if the costs preclude access, said Warraich. He pointed out that while there’s been an explosion of new HF therapies in the past decade, the population-based, age-adjusted mortality rate associated with HF is on the rise.

“Over the last few years, we have not actually seen these advances actually helping our heart failure population,” he said. “And I do think that cost is a huge barrier.”

However, he also pointed out there is another issue at play.   

“We haven't made a good value proposition for heart failure,” said Warraich. “What does that mean? If any of these novel medications were, let's say, treating another indication such as maybe Alzheimer's disease or cancer and had a similar type of outcome, these would be blockbuster drugs. I think people would be lining up in the streets to get these medications. People just don't think about heart failure, or heart disease in general, with quite the same type of seriousness that we do with other conditions [and so] patients are not as willing to pay.”

To change that, the cardiology community needs to effectively communicate that HF is a serious disease with significant morbidity that can impact human life more adversely than many cancers or other disease states, said Warraich.

“That might sensitize people to associate value with these new therapies,” he said.

Economics of Devices for HF

Turning to the device side of the HF equation, the economics don’t hold up quite as well, although it depends on the clinical circumstances, according to the researchers.

For example, the society-level benefit of defibrillators for reducing sudden cardiac death depends on background population risk, with studies showing that these devices are most beneficial in patients with ischemic cardiomyopathy. In the setting of nonischemic cardiomyopathy, however, the incremental cost-effective ratio (ICER) can range from $80,000 to more than $155,000 per QALY. 

For other devices, such as mechanical circulatory support (MCS), these all have big upfront technology costs. When MCS is used as a bridge to transplant, studies have shown ICERs ranging from $80,000 to more than $200,000 per QALY gained. The value of transcatheter edge-to-edge repair with MitraClip (Abbott) for patients with severe secondary mitral regurgitation is also difficult to assess given that COAPT was a positive trial—and was associated with an ICER of $55,600 per QALY gained—and MITRA-FR was neutral, according to the HFSA. Similarly, they say, studies of invasive hemodynamic measures to manage chronic HF, such as CardioMEMS (St. Jude Medical), have also shown mixed results. 

Warraich believes there is a risk of overusing device technology even though the evidence isn’t anywhere as strong as the data supporting cost-effective pharmacologic therapy. That’s largely the result of the way reimbursement works in the US, with hospitals making more money for procedures. 

“It really will fall on our community as a whole, because all our resources are finite,” he said. “I think we all have a responsibility to focus and lead our patients to therapies that are more cost-effective and that are more likely to benefit them and that have a stronger evidence base.”