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Furoscix (furosemide) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1196
This program applies to Blue Partner, Commercial, GenPlus, NetResults A, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
07-01-2023 |
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Furoscix® (furosemide) Subcutaneous cartridge kit |
Treatment of congestion due to fluid overload in adults with 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 |
|
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Management of Heart Failure |
The 2022 AHA/ACC/HFSA Guidelines for the Management of Heart Failure (HF) recommends the following on diuretic and decongestion strategies in patient with HF (Strong evidence):(8)
Commonly Used Oral Loop Diuretics in Treatment of Congestion for Chronic HF include the following:(8)
Effective diuretic action in HF requires four discrete steps: 1) ingestion and gastrointestinal absorption (if given orally), 2) delivery to the kidney, 3) secretion into the tubule lumen; and 4) binding to the transport protein.(5) Controlled trials with diuretics showed their effects to increase urinary sodium excretion, decrease physical signs of fluid retention, and improve symptoms, quality of life, and exercise tolerance. Recent data from the nonrandomized OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure) registry revealed reduced 30-day all-cause mortality and hospitalization for HF with diuretic use compared with no diuretic use after hospital discharge for HF. The most commonly used loop diuretic for the treatment of HF is furosemide, but some patients respond more favorably to other agents in this category (e.g., bumetanide, torsemide), potentially because of their increased oral bioavailability.(8) Parenteral loop diuretics form the cornerstone of treatment of acute decompensated HF when patients respond insufficiently to oral diuretics alone. HF syndrome is characterized by unpredictable periods of decompensation, which require escalation of oral diuretic doses and/or frequency of dosing. When such oral treatment adjustment fails, IV diuretics are usually prescribed. Furthermore, many patients appear to temporarily have a reduced response to oral medication due to impaired absorption because of fluid overload and other factors affecting gastric and intestinal absorptive functions.(6) For patients on long-term loop diuretic agents, it is suggested that patients hospitalized with HF and congestion initially start loop diuretic dosage at 2.5 times their outpatient dose on a mg per mg basis. For example, for patients taking 40 mg of oral furosemide twice daily as an outpatient, initial intravenous (IV) dosing would be 100 mg of furosemide IV twice daily. For patients not receiving long-term loop diuretic agents, 40-80 mg IV BID of furosemide or the equivalent is a reasonable, empiric, starting dose. Due to post-dosing sodium retention, IV loop-diuretic agents should usually be given at least twice daily.(5) The average bioavailability after oral administration of furosemide is highly variable and has been reported to range between 49% and 72%, while individual differences range from below 20% to over 90%. Parenteral furosemide therapy not only reduces hypervolemia, but in many patients, it also restores oral bioavailability, allowing them to transition more readily back to oral maintenance therapy.(6) Parenteral therapy routinely requires emergency room or inpatient care. A novel buffered furosemide formulation (Furoscix) with neutral pH was developed to offer diuresis for outpatient use, including self-administration at home. Subcutaneous infusion using a biphasic delivery profile resulted in complete bioavailability (99.65%) and equivalent diuresis when compared with intravenous administration. Subcutaneous administration of buffered furosemide was well tolerated with no evidence of any drug-induced skin reactions. Subcutaneous infusion of buffered furosemide in the outpatient setting or home may help to reduce the burden of heart failure.(6) |
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Efficacy |
Furoscix is a proprietary furosemide solution formulated to a neutral pH, designed to allow for subcutaneous infusion via a wearable, pre-programmed on-body infusor, for outpatient self-administration. It was developed for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure who display reduced responsiveness to oral diuretics and who do not require hospitalization.(1,4) The PK/PD Pivotal (Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously vs. the Same Dose Administered Intravenously in Subjects With Chronic Heart Failure; NCT02329834) study compared the pharmacokinetics and bioavailability of an 80-mg buffered furosemide solution administered via the SC route with an equivalent 80-mg dose of IV furosemide in a similar subject population. The main findings of this study were: 1) typical therapeutic levels of furosemide were reached within 30 min of SC administration and maintained for more than 5 h; 2) absolute bioavailability of SC furosemide was complete at 99.65%; 3) SC furosemide was as effective as IV furosemide in achieving diuresis; and 4) SC furosemide was well tolerated, with minimal erythema and edema at the site of injection.(6) These results suggest that SC furosemide administration may offer a “hospital-strength” diuretic option for patients with HF who require a shift of their oral diuretic treatment, when hospitalization is not strictly warranted. These results also suggest that the reformulation combined with the slow infusion rate has resulted in a product that is free from the stinging and discomfort that had been reported with the administration of conventional furosemide injection.(6) The AT HOME-HF Pilot study (NCT04593823), a Phase 2 multicenter, randomized study that compared Furoscix with a “treatment as usual” approach in chronic heart failure patients presenting to a heart failure clinic with worsening congestion and requiring augmented diuresis. The study enrolled 63 subjects, of which 34 received FUROSCIX and 17 received “treatment as usual. Results indicated a 37% reduction in heart failure hospitalizations relative to ‘treatment as usual’ and improvement in congestion signs and symptoms.(11) The FREEDOM-HF was a multicenter, adaptive clinical trial that included a prospective treatment arm (i.e., Furoscix administered via the Furoscix Infusor) administered outside the hospital that was compared to a propensity-matched historical control arm of patients admitted to the hospital for less than or equal to 72 hours (i.e., Treatment As Usual (TAU)) that was derived from administrative claims data. Eligible patients for the Furoscix arm had NYHA Class II or III heart failure and were exhibiting signs of volume expansion defined as: jugular venous distention, pitting edema (greater than or equal to 1+), abdominal distension, pulmonary congestion on chest x-ray, or pulmonary rales.(4) Results of the FREEDOM-HF study showed positive results demonstrating the average 30-day heart failure related costs were reduced in the Furoscix arm compared to historically matched comparators (p<0.0001). Comparators were hospitalized for less than or equal to 72 hours and were selected from a claims database matched to seven variables associated with HF-related hospitalization and severity.(9) Analyses of additional secondary endpoints have been conducted that provide additional insights into the clinical effectiveness of Furoscix. Patients who received Furoscix had a median reduction of heart failure peptide biomarkers from study entry (day 0) to first visit (day 2 to 4), and to last visit (day 30), of 42.3% and 28%, respectively (p less than or equal to 0.01). Patients who received Furoscix had a 12.8-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Summary Score 30 days after study entry.(10)
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Safety |
Furoscix is contraindicated in patients with:(1)
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REFERENCES
Number |
Reference |
1 |
Furoscix prescribing information. scPharmaceuticals, Inc. November 2023. |
2 |
Reference no longer used |
3 |
Reference no longer used |
4 |
Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure (FREEDOM-HF). Available at https://beta.clinicaltrials.gov/study/NCT03458325 |
5 |
Felker GM, Ellison DH, Mullens W, Cox ZL, Testani JM. Diuretic Therapy for Patients With Heart Failure: JACC State-of-the-Art Review. J Am Coll Cardiol 2020;75:1178-1195. |
6 |
Sica DA, Muntendam P, Myers RL, Ter Maaten JM, Sale ME, de Boer RA, Pitt B. Subcutaneous Furosemide in Heart Failure: Pharmacokinetic Characteristics of a Newly Buffered Solution. JACC Basic Transl Sci. 2018 Feb 7;3(1):25-34. doi: 10.1016/j.jacbts.2017.10.001. PMID: 30062191; PMCID: PMC6059009. |
7 |
Reference no longer used |
8 |
Heidenreich, Paul A. Heidenreich, MD, MS, FACC, FAHA, FHFSA, Chair, Bozkurt, Biykem Bozkurt, MD, PhD, FACC, FAHA, FHFSA, Vice Chair, et.al, 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. 2022;145:e895–e1032. Available at: https://doi.org/10.1161/CIR.0000000000001063Circulation. |
9 |
scPharmaceuticals Inc. Presents Late-breaking FREEDOM-HF Study Data at the Heart Failure Society of America Annual Scientific Meeting 2021. Available at: https://scpharmaceuticalsinc.gcs-web.com/news-releases/news-release-details/scpharmaceuticals-inc-presents-late-breaking-freedom-hf-study. |
10 |
Effect of Subcutaneous Furosemide (Furoscix) on Natriuretic Peptides, Quality of Life and Patient/Caregiver Satisfaction in Heart Failure Patients: Secondary Outcomes of the FREEDOM-HF Trial. Presented at The American Association of Heart Failure Nurses 18thAnnual Meeting in Orlando, FL on June 18, 2022. Available at: http://ir.scpharma.com/static-files/0fdebb90-5032-4f86-afc1-a8279df9c74e |
11 |
Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study (AT HOME-HF). Available at https://clinicaltrials.gov/ct2/show/NCT04593823 |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Furoscix |
furosemide subcutaneous cartridge kit |
80 MG/10ML |
M ; N ; O ; Y |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Furoscix |
Furosemide Subcutaneous Cartridge Kit |
80 MG/10ML |
8 |
Kits |
180 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Furoscix |
furosemide subcutaneous cartridge kit |
80 MG/10ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Furoscix |
Furosemide Subcutaneous Cartridge Kit |
80 MG/10ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
PA |
Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: Up to 12 months |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
Commercial _ PS _ Furoscix_PAQL _ProgSum_ 10-01-2024