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Prior Authorization Protocol
ANTARAR, FENOGLIDER, LOFIBRAR, LIPOFENR, TRICORR, TRIGLIDER (fenofibrate),
FIBRICOR
R(fenofibric acid), TRILIPIXTM (choline fenofibrate)

HNMC
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Hypertriglyceridemia Type IV and V
    • Mixed dyslipidemia or hyperlipidemia Type IIa and IIb
    • Primary hypercholesterolemia
  2. Health Net Approved Indications and Usage Guidelines:
    • Failure or clinically significant adverse effects from gemfibrozil (LopidR), Antara 43 mg or 130 mg
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • Failure of gemfibrozil to control hypertriglyceridemia calls for addition of a second agent or a change in the class of agent, not a switch to fenofibrate.
    • Incomplete control of diabetes is often a cause of hypertriglyceridemia. Control of diabetes is preferred before specific therapy directed against hyperlipidemia is initiated or changed.
    • Low dose niacin (1,500mg daily) or bile acid binding resins (4 to 8gm daily, 1 to 2 packets or scoops) can reduce LDL cholesterol by an additional 30% when added to an HMG Co-A inhibitor.
    • Results of the ACCORD trial indicate the combination of fenofibrate and simvastatin did not reduce the rate of fatal cardiovascular events, nonfatal myocardial infarction, or nonfatal stroke, as compared with simvastatin alone in patients with diabetes. These results do not support the routine use of combination therapy with fenofibrate and simvastatin to reduce cardiovascular risk in the majority of high-risk patients with type 2 diabetes.†
    • In general, the combination of HMG Co-A inhibitors and gemfibrozil or fenofibrate is not contraindicated. HMG-induced myopathy/rhabdomyolysis is considered a class effect and has been seen with all the currently available agents. A recent study found the incidence of myopathy to be only 0.4% with the gemfibrozil combination. (Am Heart J 1999:138(1pt1):151-5.
    • Niacin is not absolutely contraindicated in the American Diabetes Association (ADA) guidelines and is recommended for use in combination therapy. Doses below 2000mg daily usually have little influence on glucose control. The ADA has positioned the combination of niacin with an HMG Co-A inhibitor as third line for mixed hyperlipidemia.
    • Place patients on an appropriate lipid-lowering diet before receiving fenofibrate and continue this diet during treatment. Give with meals, thereby optimizing the bioavailability of the medication.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    gemfibrozil (LopidR)

    600 mg PO BID

    1200 mg/day

    HMG Co-A reductase inhibitors
    atorvastatin (LipitorR)
    fluvastatin (LescolR, Lescol XLR)
    lovastatin (MevacorR)
    pravastatin (PravacholR)
    simvastatin (ZocorR)


    Various depending on patient's diagnosis
    and previous therapy


    Varies

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    AntaraR (fenofibrate)

    Primary hypercholesterolemia and mixed hyperlipidemia
    90 mg PO QD
    Hypertriglyceridemia
    30 - 90 mg PO QD

    Length of benefit

    FenoglideR (fenofibrate)

    Primary hyperlipidemia and mixed dyslipidemia
    120 mg PO QD
    Hypertriglyceridemia
    40-120 mg PO QD

    Length of Benefit

    fenofibrate (LofibraR)

    Primary hypercholesterolemia and mixed hyperlipidemia
    200 mg PO QD
    Hypertriglyceridemia
    67 to 200 mg PO QD

    Length of Benefit

    fenofibrate (LipofenR)

    Primary hypercholesterolemia and mixed hyperlipidemia
    150 mg PO QD
    Hypertriglyceridemia
    50-150 mg PO QD

    Length of Benefit

    fenofibrate (TricorR)

    Primary hypercholesterolemia and mixed hyperlipidemia
    145 mg PO QD
    Hypertriglyceridemia
    48 to 145 mg PO QD

    Length of Benefit

    fenofibrate (TriglideR)

    Primary hypercholesterolemia and mixed hyperlipidemia
    160 mg PO QD
    Hypertriglyceridemia
    50-160 mg PO QD

    Length of Benefit

    fenofibric acid (FibricorR)

    Severe hypertriglyceridemia
    35-105 mg PO QD
    Primary hypercholesterolemia and mixed dyslipidemia
    105 mg PO QD

    Length of Benefit

    fenofibric acid (TrilipixR)

    Mixed dyslipidemia
    135 mg PO QD
    Hypertriglyceridemia
    45-135 mg PO QD

    Length of Benefit

  7. Product Availability:
    • Antara (micronized) 30 mg, 90 mg capsules
    • Fenoglide 40 mg, 120 mg tablets
    • Lofibra 67 mg, 134 mg, 200 mg micronized capsules, 54 mg, 160 mg tablets
    • Lipofen 50 mg, 150 mg capsules
    • Tricor 48 mg, 145 mg tablets
    • Triglide 50 mg, 160 mg tablets
    • Fibricor 35 mg, 105 mg tablets
    • Trilipix 45, 135 mg delayed release capsules
  8. References:
    1. Antara [Prescribing Information] Baltimore, MD: Lupin Pharma; October 2013.
    2. Fenoglide [Prescribing Information] Stamford, CT: Shore Therapeutics, Inc; October 2012
    3. Lofibra [Prescribing Information] Jerusalem, Israel: Teva Pharmaceutical Ind; August 2012.
    4. Lipofen [Prescribing Information] Montgomery, AL: Kowa Pharmaceuticals America, Inc.; January 2013.
    5. Tricor [Prescribing Information] North Chicago, IL: Abbott Laboratories; Feb 2013.
    6. Triglide [Prescribing Information] Florham Park, NJ: Shionogi Pharma, Inc.;†April 2015.
    7. Fibricor [Prescribing Information] Philadelphia, PA: AR Scientific, Inc.; March 2013.
    8. Trilipix [Prescribing Information] North Chicago, IL: Abbott Laboratories; March 2013.
    9. Micromedex Healthcare Series [Internet database]. Micromedex Web site. Available at: https://www.thomsonhc.com. Accessed July 10, 2014.
    10. Antara. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 10, 2014.
    11. Fenoglide. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 10, 2014.
    12. Lofibra. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 10, 2014.
    13. Lipofen. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 10, 2014.
    14. Tricor. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 10, 2014.
    15. Triglide. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 10, 2014.
    16. Fibricor. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 10, 2014.
    17. Trilipix. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 10, 2014
    18. The ACCORD Study Group. Effects of Combination Lipid Therapy in Type 2 Diabetes Mellitus. N Engl J Med 2010; 362:1563-1574 April 29, 2010
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.