Pharmacy Prior Authorization Criteria

Fibric Acid Derivatives

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.

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 (of a minimum 30 day supply) or intolerance to both of the following:

AND

2025-03-24, 2024-04-02, 2023-09-06, 2023-01-04, 2022-09-01, 2021-09-01, 2020-08-18, 2019-09-05

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

2025-03-24: 2025 Annual Review. Updated trial and failure language to standard format.
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