CurrentCignaPolicy IP0339

fenofibrate_medical_necessity_criteria

Defines medical necessity criteria, authorization duration, reauthorization, non-covered uses, and supported fenofibrate products (Antara, fenofibrate capsules/tablets, Fenoglide) for Cigna-administered health plans. Applies to prior authorization and utilization review decisions for specified fenofibrate products.

Policy Summary

PayerCigna

Policyfenofibrate_medical_necessity_criteria

Policy CodePolicy IP0339

Change TypeNo material change

Effective DateJan 15, 2024

Next Review DateJan 15, 2025

Key ActionRequests require prior authorization with documentation of failure/contraindication/intolerance to three listed products for non-covered product exceptions and evidence of beneficial response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

4Products listed for trial before exception

12Initial/Reauth approval duration (months)

Coverage Summary

Overview: Fenofibrate and fenofibric acid are oral lipid-regulating agents indicated as adjuncts to diet to modify LDL-C, total cholesterol, triglycerides (TG), apolipoprotein B (Apo B) and to increase HDL-C in adults with primary hypercholesterolemia or mixed dyslipidemia, and for the treatment of hypertriglyceridemia.

Limits and applicability: Coverage is covered_with_criteria under Cigna-administered plans (Coverage Policy Number IP0339) when the medical necessity criteria in this policy are met, including product-specific supported agents and documentation requirements for non-covered product exceptions; prior authorization and utilization review decisions are guided by this policy.

Medical Necessity Criteria

Initial Medical Necessity Criteria for Fenofibrate Products

Covered when ALL of the following are met:

ALL of the following

Request is for one of the supported fenofibrate products: Antara (fenofibrate), fenofibrate 30 mg capsules, fenofibrate 90 mg capsules, or Fenoglide (fenofibrate)
Use is as an adjunct to diet for one of the product indications: primary hypercholesterolemia or mixed dyslipidemia, or hypertriglyceridemia
THREE of the following (must document for non-covered product exception)
- fenofibric acid DR capsule (Trilipix generic)
- fenofibrate tablet (Tricor/Lofibra generic)
- fenofibric acid tablet (Fibricor generic)
- fenofibrate capsule (Lipofen generic)

ref': 'b1_0

title': 'Initial Medical Necessity Criteria for Fenofibrate Products

ref

Reauthorization Criteria (Continuation Therapy)

Continuation is covered when ALL of the following are met:

ALL of the following

Original medical necessity criteria (above) are met
Documentation of beneficial response to therapy

ref': 'b1_1

title': 'Reauthorization Criteria (Continuation Therapy)

ref

Conditions Not Covered / Experimental or Unproven Uses

Not covered when ANY of the following apply:

Any use that is not specified in the medical necessity criteria or labeled indications is considered experimental, investigational, or unproven

Provider Actions & Authorization

Prior Authorization

Prior authorization required per policy

Requests for the specified fenofibrate products require medical necessity review and prior authorization per this policy. For Employer Group Non-Covered Product exceptions, documentation must include failure, contraindication, or intolerance to THREE of the listed alternative fenofibrate/fenofibric acid products. Reauthorization also requires documentation of beneficial response per the criteria.

Antara (fenofibrate)
fenofibrate 30 mg and 90 mg capsules
Fenoglide (fenofibrate)

Note

Authorization duration

Initial and reauthorization approvals are each up to 12 months.

12 months

Documentation Required

Documentation requirements for non-covered product exceptions

For Employer Group Non-Covered Product exceptions, document failure, contraindication, or intolerance to THREE specific alternatives before coverage of a non-covered fenofibrate product will be considered.

fenofibric acid DR capsule (Trilipix generic)
fenofibrate tablet (Tricor/Lofibra generic)
fenofibric acid tablet (Fibricor generic)
fenofibrate capsule (Lipofen generic)

Background, Evidence & Definitions

Fenofibrate/fenofibric acid are indicated as adjuncts to diet to reduce LDL-C, total cholesterol, TG, and Apo B and to increase HDL-C in adults with primary hypercholesterolemia or mixed dyslipidemia, and for the treatment of hypertriglyceridemia. A limitation of use is that these products have not been shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (ACCORD study and product prescribing information).

Key references: Prescribing information for multiple fenofibrate products (TriCor, Antara, Lipofen, Fenoglide, Trilipix, Fibricor, and others) and the ACCORD study (Ginsberg et al., N Engl J Med. 2010) evaluating combination lipid therapy in type 2 diabetes.

Non-Covered Product Exception: A process where coverage for a non-covered fenofibrate product may be granted if documentation shows failure, contraindication, or intolerance to THREE specified alternatives (fenofibric acid DR capsule [Trilipix generic]; fenofibrate tablet [Tricor/Lofibra generic]; fenofibric acid tablet [Fibricor generic]; fenofibrate capsule [Lipofen generic]).

Revision History

2024-01-15effective

Policy effective date (no material changes noted in brief).

2024-01-15last_reviewLatest

Policy last reviewed (no material changes noted in brief).

2025-01-15next_review

Next scheduled review.