Pharmacy Prior Authorization Criteria

Fibric Acid Derivatives

Indications for Prior Authorization

Fenoglide, Fibricor

• For diagnosis of Primary Hypercholesterolemia and Mixed Dyslipidemia
  Indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.

  Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus.

• For diagnosis of Severe Hypertriglyceridemia
  Indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention.

  Markedly elevated levels of serum triglycerides (e.g., > 2000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.

  Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus.

Criteria

Brand Fenoglide, Brand Fibricor

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure or intolerance to a minimum 30 day supply to both of the following:
• One of the following generics:
• fenofibrate micronized capsule
• fenofibrate tablet
• fenofibric capsule
• fenofibric acid tablet
AND
• One of the following:
• Brand Lipofen
• Generic fenofibrate capsule

P & T Revisions

2024-04-02, 2023-09-06, 2023-01-04, 2022-09-01, 2021-09-01, 2020-08-18, 2019-09-05

References

1. Fenoglide Prescribing Information. Salix Pharmaceuticals. Bridgewater, NJ. June 2021.
2. Fibricor Prescribing Information. Athena Bioscience, LLC. Athena, GA. December 2020.

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Revision History

• 2024-04-02: Annual Review - No criteria changes
• 2023-09-06: Annual Review - No criteria changes
• 2023-01-04: Triglide will be removed as target drug as product obsolete. ST criteria for Fenoglide and Fibricor will be updated to include generic Lipofen as an additional trial option.
• 2022-09-01: 2022 Annual Review - Update to add criteria "Requested drug is being used for a Food and Drug Administration (FDA)-approved indication"
• 2021-09-01: Annual review: Updated attached target drugs and background.
• 2020-08-18: Updated criteria to indicate 30 day supply trial of maintenance drugs.
• 2019-09-05: Guideline updated

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