CurrentCignaPolicy IP0339

Fenofibrate (Antara, fenofibrate capsules, Fenoglide) Coverage Criteria

Policy governing medical necessity review and coverage criteria for specific fenofibrate products for Cigna-administered health benefit plans; affects providers requesting coverage for Antara, fenofibrate 30 mg and 90 mg capsules, and Fenoglide products.

Policy Summary

PayerCigna

PolicyFenofibrate (Antara, fenofibrate capsules, Fenoglide) Coverage Criteria

Policy CodePolicy IP0339

Change TypeNo material change

Effective DateJan 15, 2024

Next Review DateJan 15, 2025

Key ActionObtain prior authorization with documentation of failure, contraindication, or intolerance to three specified alternative fenofibrate/fenofibric acid products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3named fenofibrate products covered

3required failures of alternatives

12approval duration (months)

1/15/2024effective date

Coverage Criteria

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inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial coverage for named fenofibrate products: 1) Request is for one of the named products: Antara (fenofibrate), fenofibrate 30 mg or 90 mg capsules, or Fenoglide (fenofibrate 40 mg or 120 mg tablets). 2) Documentation of failure, contraindication, or intolerance to THREE of the following alternatives: fenofibric acid DR capsule (Trilipix generic); fenofibrate tablet (Tricor/Lofibra generic); fenofibric acid tablet (Fibricor generic); fenofibrate capsule (Lipofen generic).three failures/contraindication/intolerance

Receipt of sample product does not satisfy criteria for coverage.

inv-02: Reauthorization / Continuation Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Reauthorization: Medical necessity criteria from initial approval continue to be met AND there is documentation of beneficial response to therapy.beneficial response documented

Reauthorization duration: up to 12 months.

Initial Authorization

inv-10: Initial Authorization — initial coverage requirements

Initial coverage requirements

Initial: Request for a named fenofibrate product (Antara; fenofibrate 30 mg or 90 mg capsules; or Fenoglide) with documentation of failure, contraindication, or intolerance to THREE specified alternative fenofibrate/fenofibric acid products.3 alternatives failed/contraindicated/intolerant

Receipt of sample product does not satisfy criteria for coverage.

Reauthorization / Continuation

inv-11: Reauthorization — continuation of therapy requirements

Continuation of therapy requirements

Continuation: Initial medical necessity criteria remain met and documentation of beneficial clinical response to therapy is provided.documented benefit

Reauthorization approval duration: up to 12 months.

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Antara (fenofibrate), fenofibrate 30 mg and 90 mg capsules, and Fenoglide (fenofibrate). Requests must include documentation that the member has failed, has a contraindication to, or is intolerant of three specified alternative fenofibrate/fenofibric acid products.

Antara (fenofibrate 30 mg and 90 mg capsules)
fenofibrate 30 mg and 90 mg capsules
Fenoglide (fenofibrate 40 mg and 120 mg tablets)

Step Therapy

Step Therapy Alternatives

Step therapy requirement: coverage for Antara, fenofibrate capsules, or Fenoglide is contingent on documentation of failure, contraindication, or intolerance to THREE alternatives listed below.

Step therapy = trial and failure (or contraindication/intolerance) of THREE alternatives

Documentation Required

Failure to Alternatives — Documentation Required

Documentation must show failure, contraindication, or intolerance to three of the following alternatives when requesting coverage: 1) fenofibric acid delayed-release capsule (Trilipix® generic), 2) fenofibrate tablet (Tricor®/Lofibra® generic), 3) fenofibric acid tablet (Fibricor® generic), 4) fenofibrate capsule (Lipofen™ generic).

Required alternatives: Trilipix generic (fenofibric acid DR capsule); Tricor/Lofibra generics (fenofibrate tablet); Fibricor generic (fenofibric acid tablet); Lipofen generic (fenofibrate capsule)
Documentation must clearly indicate failure, contraindication, or intolerance for each of three alternatives

Denial Risk

Non‑Covered Uses

Use of these products for any indication other than those specified in this policy is considered experimental, investigational, or unproven and may be denied.

Requirement	Details
Step therapy requirement	Documentation of failure, contraindication, or intolerance to THREE of the following alternatives: fenofibric acid delayed‑release capsule (Trilipix generic); fenofibrate tablet (Tricor/Lofibra generic); fenofibric acid tablet (Fibricor generic); fenofibrate capsule (Lipofen generic).

Background

Fenofibrate and fenofibric acid are oral lipid-regulating agents indicated as adjuncts to diet for adults with primary hypercholesterolemia, mixed dyslipidemia, or hypertriglyceridemia. These agents reduce LDL-C, total cholesterol, triglycerides, and apolipoprotein B, and increase HDL-C. Clinical trials of these products have not demonstrated a reduction in coronary heart disease morbidity and mortality in patients with type 2 diabetes.

Definitions

inv-09: Fenofibrate / fenofibric acid — definition and indication summary

DefinitionFenofibrate and fenofibric acid are oral lipid‑regulating agents available in multiple formulations and indicated as an adjunct to diet to reduce LDL‑C, total cholesterol, triglycerides and apolipoprotein B, and to increase HDL‑C in adults with primary hypercholesterolemia or mixed dyslipidemia.

Additional indicationIndicated for treatment of adults with hypertriglyceridemia (as an adjunct to diet).

Limitation of useProducts have not been shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus.

FormulationsAvailable in various oral formulations (brand and generic; some products have undergone reformulations).

Examples of covered named products (policy scope)Antara (fenofibrate); fenofibrate 30 mg and 90 mg capsules; Fenoglide (fenofibrate 40 mg and 120 mg tablets).

Coding and Exclusions