FUROSCIX (furosemide)

FUROSCIX (furosemide)

Self-Administration – injectable

Indications for Prior Authorization:

• Congestion due to fluid overload - Indicated for the treatment of congestion due to fluid overload in adults with New York Heart Association (NYHA) Class II/III chronic heart failure.

  • Limitations of Use:

    • FUROSCIX is not indicated for emergency situations or in patients with acute pulmonary edema. 

    • The On-Body Infusor will deliver only an 80-mg dose of FUROSCIX

Coverage Criteria:

For diagnosis of congestion due to fluid overload:

• Dose does not exceed 80 mg per dose (1 cartridge); AND 

• Patient is 18 years of age or older; AND

• Diagnosis of chronic heart failure; AND

• Patient has New York Heart Association (NYHA) Class II or III; AND

• Medical records AND prescription claim data confirm the patient is currently on a daily oral loop diuretic maintenance therapy (e.g., bumetanide 1-4mg, furosemide 40-160mg, or torsemide 20-80mg); AND 

• Provider attests to ALL of the following:

  • Member is showing signs of extracellular volume expansion due to chronic heart failure, defined as one of the following:

    • jugular venous distention

    • pitting edema (≥1+)

    • abdominal distension

    • pulmonary congestion on chest X-ray

    • pulmonary rales

  • Patient will be closely monitored for fluid, electrolyte, and metabolic abnormalities throughout therapy (e.g., hypokalemia, hypovolemia, hyponatremia) 

Coverage Duration:

• 3 months

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Dosage and Administration

  • The single-use, on-body infusor is pre-programmed to deliver 30 mg of FUROSCIX over the first hour then 12.5 mg per hour for the subsequent 4 hours. Total dose of 80mg over 5 hours

  • FUROSCIX is not for chronic use and should be replaced with oral diuretics as soon as practical

  • Maintenance oral diuretic therapy includes those receiving 40-160 mg of oral furosemide equivalents daily (20-80 mg torsemide or 1-4 mg bumetanide)

• Contraindications

  • Anuria

  • Hepatic cirrhosis or ascites

  • Hypersensitivity to furosemide or medical adhesives 

• Precautions

  • Fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and elderly patients

  • Worsening renal function 

  • Ototoxicity 

• DDI

  • Aminoglycoside antibiotics: Increased potential ototoxicity of the antibiotics. Avoid combination

  • Ethacrynic acid: Risk of ototoxicity. Avoid combination 

  • Salicylates: Risk of salicylate toxicity

  • Cisplatin and nephrotoxic drugs: Risk of ototoxicity and nephrotoxicity

  • Lithium: Risk of lithium toxicity

  • Renin-angiotensin inhibitors: Increased risk of hypotension and renal failure 

  • Adrenergic blocking drugs: Risk of potentiation

  • Drugs undergoing renal tubular secretion: Risk of toxicity potentiation

Policy Updates:

• 06/01/2023 – New policy approved by P&T

References:

• American Heart Association. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 April;145(18):e895-e1032

• Furoscix Prescribing Information. scPharmaceuticals, Inc. Burlington, MA. October 2022. 

• scPharmaceuticals, Inc. A Multicenter, Randomized, Open Label, Controlled Study Evaluating the Effectiveness and Safety of Furoscix On-Body Infusor vs Continued Medical Therapy for Worsening Heart Failure. clinicaltrials.gov. Published May 3, 2022. 

• scPharmaceuticals, Inc. Economic Impact of Reducing Hospital Admissions for Patients Presenting to the Emergency Department With Worsening Heart Failure: An Adaptive Clinical Trial of Furoscix Infusor. clinicaltrials.gov. Published July 9, 2021.

• scPharmaceuticals, Inc. Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure. clinicaltrials.gov identifier: NCT03458325. Published February 24,2023.

• Sica DA, Muntendam P, Myers RL, et al. Subcutaneous furosemide in heart failure: pharmacokinetic characteristics of a newly buffered solution. JACC Basic Transl Sci 2018 Feb;3:25-34