The burden of heart failure
Heart failure (HF) is a chronic disease that affects approximately 6.5 million adults in the United States with an estimated 15 million hospital days spent each year. Treatment costs associated with HF patients represents $123 billion, or 33%, of annual Medicare Part A and B spending. HF is one of the most common reasons for hospital admissions and readmissions in patients age 65 and over.
One in every 33 Americans will be living with heart failure and its consequences in just over a decade.
HF is the decreasing ability of the heart to pump blood effectively, which in turn limits the supply of oxygen-rich blood and impairs the body’s capacity to function properly. As the condition worsens, the body increasingly retains fluid in the lungs, liver, gastrointestinal tract, arms and legs. This fluid retention leads to edema, a swelling of the body tissues most commonly seen in the extremities. As HF-related edema progresses, it is often accompanied by shortness of breath and fatigue. The onset or increase of these symptoms is referred to as acute decompensated heart failure (ADHF). ADHF typically requires medical attention or hospitalization.
In patients hospitalized for HF, edema is the most common factor associated with decompensation. To treat edema, a class of drugs called diuretics is used to increase blood flow and prevent reabsorption of salt and potassium into the blood stream. While oral diuretics are sufficient for the treatment of patients with mild edema, intravenous (IV) loop diuretics are universally recommended for more severe edema and require costly hospital admission.
Once a patient is stabilized, hospitals must decide between keeping the patient for further diuresis—and absorbing the high cost for this—or discharging the patient so they may continue diuresis at home. In many instances, patients are discharged on an oral diuretic, before diuresis is complete. Approximately 25%-30% of HF patients on Medicare are readmitted to the hospital within 30 days of discharge, resulting in increased healthcare costs and potential penalties for the hospital.
Many HF patients do not require advanced procedures while hospitalized—only IV diuresis—and we predict that a subset of these patients could continue their treatment at home, with the support of our product, after a short hospital stay.
The promise of subcutaneous furosemide
Furosemide is a standard-of-care diuretic featured on the World Health Organization’s List of Essential Medicines and represents over 90% of the IV loop diuretics utilized. However, the cost and co-morbidities associated with the use of IV furosemide underscore the institutional value of outpatient infusion.
By leveraging extensive research and state-of-the-art on-body, drug delivery technology, we have developed an investigational drug product that, if approved, would be the first-ever subcutaneous formulation and delivery of furosemide.
We believe subcutaneous furosemide has the potential to create a new HF treatment paradigm by reducing high-cost hospitalizations and providing patients IV-strength diuresis with the comfort and economy of at-home care.