Quantity Limitations
Quantity limitations apply to brand and associated generic products.
Commercial Utilization Management Policy
Version Date: December 2022
Restricted Product(s)
- Furoscix® (furosemide injection for subcutaneous use)
FDA Approved Use
- For the treatment of congestion due to fluid overload in adults with New York Heart Association (NYHA) Class II and Class III chronic heart failure.
Criteria for Approval of Restricted Product(s)
- The patient has a diagnosis of NYHA Class II or III chronic heart failure with congestion (medical record documentation required); AND
- The patient is 18 years of age or older; AND
- The patient is currently on background oral loop diuretic therapy; AND
- The patient has signs and symptoms of fluid overload (e.g., dyspnea, pitting edema, weight gain, etc.); AND
- The patient is refractory to increasing dose of oral diuretic therapy (medical record documentation required); AND
- The patient is stable and suitable for at-home treatment with Furoscix evident by stable vital measurements (e.g., oxygen saturation, respiratory rate, heart rate, systolic blood pressure etc.); AND
- The patient has NO evidence of acute renal failure; AND
- The patient has NO evidence of acute pulmonary edema, hepatic cirrhosis or ascites, or other conditions that require immediate or anticipated hospitalization; AND
- Background oral diuretic therapy will be discontinued during treatment with Furoscix and then patient should be transitioned back to oral diuretic maintenance therapy; AND
- The patient has an adequate environment for at home administration of Furoscix by patient or caregiver; AND
- The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., cardiologist) (medical record documentation required); AND
- For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
Duration of Approval: 30 days
| Medication | Quantity |
|---|---|
| Furoscix® subcutaneous cartridge kit 80 mg / 10 mL injection | 8 kits per 30 days |
Quantity Limit Exception Criteria
- The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
- The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
- The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
- If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
Duration of Approval: 365 days (1 year)
References
All information referenced is from FDA package insert unless otherwise noted below.
Policy Implementation/Update Information
December 2022: Criteria change: Removed requirement of clinical response to IV furosemide. Expanded and clarified upon patient is stable and suitable for home administration. Added quantity limit.
November 2022: Original utilization management policy issued.
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