CurrentmhnPolicy CP.PMN.207

Triclabendazole (Egaten) — Coverage for Fascioliasis

This policy governs medical necessity and coverage criteria for Egaten (triclabendazole) for treatment of fascioliasis and directs required documentation and specialist consultation for affected members across commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyTriclabendazole (Egaten) — Coverage for Fascioliasis

Policy CodePolicy CP.PMN.207

Change TypeNo material changes

Effective DateApr 2, 2019

Next Review Date

Key ActionSubmit documentation (office notes, labs or other clinical information) showing the member meets all approval criteria, including diagnosis of fascioliasis, specialist prescriber or consultation, age ≥6 years, and dosing limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥6 yrsminimum age for coverage

10 mg/kg x2maximum dosing regimen covered

4 weeksapproval duration

250 mgproduct availability

hypersensitivityknown contraindication

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Coverage Criteria for Triclabendazole (Egaten)

Initial therapy — Fascioliasis

Covered when ALL of the following are met:

Fascioliasis coverage criteria: 1) Diagnosis of fascioliasis; 2) Prescribed by or in consultation with an infectious disease specialist or gastroenterologist; 3) Age ≥ 6 years; 4) Dose does not exceed 10 mg/kg per dose for 2 doses.Two doses of 10 mg/kg PO 12 hours apart; approval duration: 4 weeks (no more than 2 total doses)

Re-authorization is not permitted; members must meet the initial approval criteria for new cases unrelated to the original request.

Other diagnoses/indications

Other diagnoses/indications (if not FDA‑approved for this policy):

Other indications: 1) If this drug has had a recent label change (within the last 6 months) not yet reflected in this policy, follow the referenced formulary/no‑coverage or non‑formulary policies for the applicable line of business (see policy references). OR 2) If the requested use (diagnosis, age, dosing) is not specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

References: CP.CPA.190, HIM.PA.33, CP.PMN.255 (no coverage) and CP.CPA.190, HIM.PA.103, CP.PMN.16 (non‑formulary) as applicable; off‑label policies: CP.CPA.09, HIM.PA.154, CP.PMN.53.

Non‑FDA approved indications are not authorized under this policy unless the request is addressed through the applicable off‑label use policy or the provider supplies sufficient documentation of efficacy and safety consistent with those off‑label policies. Refer to CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid) for requirements and acceptable supporting evidence.

Requests for re‑authorization are not permitted. Any subsequent request for treatment of a new, unrelated case of fascioliasis must meet the initial approval criteria outlined in this policy; prior approval for a different episode does not confer coverage for a new case.

Coding and Dosing Information

No specific CPT/HCPCS/NDC codes listed in policymixed

No codes listed

Maximum single dose

Maximum single dose10 mg/kg per dose

Maximum dosing regimen coveredTwo doses of 10 mg/kg PO given 12 hours apart (no more than 2 total doses)

Approval duration4 weeks (covers no more than 2 total doses)

Prior Authorization and Documentation Requirements

Documentation Required

Required documentation

Provider must submit documentation (such as office chart notes, laboratory results, or other clinical information) that supports the member meets all approval criteria for Egaten.

Examples: office chart notes documenting diagnosis and specialist consultation, relevant laboratory test results, weight for dose calculation, treatment plan and follow‑up notes.

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must document that the prescribing clinician is an infectious disease specialist or gastroenterologist, the member’s age (must be ≥ 6 years), the diagnosis of fascioliasis, and the proposed dose (not to exceed 10 mg/kg per dose for a maximum of 2 doses).

Prior authorization approval duration: 4 weeks (no more than 2 total doses).
Prescriber requirement: infectious disease specialist or gastroenterologist (or documented consultation).

Background

Triclabendazole (Egaten) is an anthelmintic agent indicated by the FDA for the treatment of fascioliasis in patients aged 6 years and older. The approved dosing regimen for fascioliasis is two doses of 10 mg/kg orally given 12 hours apart (tablets available as 250 mg), and the product labeling and CDC clinical overviews are referenced by this policy for clinical guidance.

Definitions

Egaten (triclabendazole) — definition and indication summary

Generic nameTriclabendazole

Brand nameEgaten

Indication (FDA-approved)Treatment of fascioliasis in patients 6 years of age and older

Dosage form available (policy notes)Tablets: 250 mg

Prescriber/consultation requirementPrescribed by or in consultation with an infectious disease specialist or gastroenterologist for covered use