Prior Auth Protocol

FDA Approved Indications:

To reduce elevated low-density-lipoprotein cholesterol (LDL-C), total-cholesterol (Total-C), triglycerides (TGs), and apolipoprotein B (Apo B), and to increase high-density-lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
To reduce triglyceride (TG) levels in adult patient with sever hypertriglyceridemia

Health Net Approved Indications and Usage Guidelines:

Failure or clinically significant adverse effects from gemfibrozil (Lopid^R), Antara 43 mg or 130 mg

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.
Contraindicated in patients with severe renal dysfunction, patients on dialysis, patients with active liver disease, or gallbladder disease.

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.
Contraindicated in patients with severe renal dysfunction, patients on dialysis, patients with active liver disease, or gallbladder disease.
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.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
gemfibrozil (Lopid^R)	600 mg PO BID	1200 mg/day
HMG Co-A reductase inhibitors atorvastatin (Lipitor^R) fluvastatin (Lescol^R, Lescol XL^R) lovastatin (Mevacor^R) pravastatin (Pravachol^R) simvastatin (Zocor^R)	Various depending on patient's diagnosis and previous therapy	Varies

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Antara^R(fenofibrate)	Primary hypercholesterolemia and mixed hyperlipidemia 90 mg PO QD Hypertriglyceridemia 30 - 90 mg PO QD	Length of benefit
Fenoglide^R(fenofibrate)	Primary hyperlipidemia and mixed dyslipidemia 120 mg PO QD Hypertriglyceridemia 40-120 mg PO QD	Length of Benefit
fenofibrate (Lofibra^R)	Primary hypercholesterolemia and mixed hyperlipidemia 200 mg PO QD with meals (micronized capsule) 160 mg PO QD with meals (tablet) Hypertriglyceridemia 67 to 200 mg PO QD with meals (micronized capsule) 54 160 mg PO QD with meals (tablet)	Length of Benefit
fenofibrate (Lipofen^R)	Primary hypercholesterolemia and mixed hyperlipidemia 150 mg PO QD Hypertriglyceridemia 50-150 mg PO QD	Length of Benefit
fenofibrate (Tricor^R)	Primary hypercholesterolemia and mixed hyperlipidemia 160 mg PO QD Hypertriglyceridemia 54 to 160 mg PO QD	Length of Benefit
fenofibrate (Triglide^R)	Primary hypercholesterolemia and mixed hyperlipidemia 160 mg PO QD Hypertriglyceridemia 160 mg PO QD	Length of Benefit
fenofibric acid (Fibricor^R)	Severe hypertriglyceridemia 35-105 mg PO QD Primary hypercholesterolemia and mixed dyslipidemia 105 mg PO QD	Length of Benefit
fenofibric acid (Trilipix^R)	Mixed dyslipidemia 135 mg PO QD Hypertriglyceridemia 45-135 mg PO QD	Length of Benefit

Product Availability:

Antara (micronized) capsule: 30, 90 mg
Fenoglide tablet: 40, 120 mg
Lofibra (micronized) capsule: 67, 134, 200 mg
Lofibra tablet: 54, 160 mg
Lipofen capsule: 50, 150 mg
Tricor tablet: 48, 145 mg
Triglide tablet: 160 mg
Fibricor tablet: 35, 105 mg
Trilipix (delayed-release) capsule: 45, 135 mg

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.; January 2014.

8. Trilipix [Prescribing Information] North Chicago, IL: Abbott Laboratories; April 2015.

9. Micromedex Healthcare Series [Internet database]. Micromedex Web site. Available at: https://www.thomsonhc.com. Accessed June 23, 2015.

10. Antara. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 23, 2015.

11. Fenoglide. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 23, 2015.

12. Lofibra. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 23, 2015.

13. Lipofen. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 23, 2015.

14. Tricor. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 23, 2015.

15. Triglide. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 23, 2015.

16. Fibricor. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 23, 2015.

17. Trilipix. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 23, 2015.

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.