ModifiedCentenePolicy CP.PMN.90

Benznidazole for Chagas disease

Clinical coverage policy governing medical necessity and authorization criteria for benznidazole treatment of Chagas disease for members under Centene lines of business (HIM, Medicaid). Affects prescribers, pharmacists, and authorization reviewers.

Policy Summary

PayerCentene

PolicyBenznidazole for Chagas disease

Policy CodePolicy CP.PMN.90

Change TypeMaterial coverage and operational revisions (age restriction removedtherapy limited to 60 daysnew contraindication added)

Effective DateMar 1, 2018

Next Review DateN/A

Key ActionSubmit prior authorization with supporting documentation (office notes, labs) demonstrating diagnostic confirmation and that treatment will not exceed 60 days for the current infection.

SourceLink

POLICY UPDATE CHANGES

Authorization duration for Other diagnoses/indications was revised to 60 days (from 6 months).

Removed age restriction to allow use at any age.

Added 60-day therapy limitation to initial criteria and clarified it refers to the current infection.

Updated contraindications to include Cockayne syndrome due to irreversible and potentially fatal hepatotoxicity.

Removed Commercial line of business limitation as criteria did not apply.

400 mg/daymaximum daily dose

60 daysapproval duration / treatment course authorized

2-12FDA-approved pediatric age range

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Cockayne syndromenew contraindication added

CP.PMN.90policy identifier

Coverage Criteria for Benznidazole

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

Covered when ALL of the following are met

Initial Approval - Chagas Disease diagnostic confirmation: Diagnosis of Chagas disease confirmed by one of the following: detection of circulating T. cruzi trypomastigotes on microscopy; two positive serologic IgG tests for T. cruzi using different techniques and different antigens; or detection of T. cruzi DNA by PCR.

Prescribed by or in consultation with an infectious disease specialist is required.

inv-02: Initial Therapy — Safety and dosing limits (additional required conditions — must meet all)

Additional required conditions (must meet all)

Contraindications and dosing limits: Member must not have Cockayne syndrome; weight-based dose must not exceed 400 mg per day; member has not yet received 60 days of benznidazole therapy for the current infection.400 mg/day; <60 days prior therapy

Off-label dosing requests reviewed case-by-case (see Appendix D).

inv-03: Continuation Therapy — Continued therapy covered when ONE of the following is met

Continued therapy covered when ONE of the following is met

Continued Therapy criteria: Member is currently receiving medication via Centene benefit or has previously met initial approval criteria; member has not yet received 60 days of benznidazole therapy for the current infection; or continuity of care regulations apply for the state/product.60 days total treatment

If request is for a dose increase, new dose (weight-based) must not exceed 400 mg/day.

inv-04: Initial and Continued Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial/Continuation Therapy Requirements: Patient has a diagnosis of Trypanosoma cruzi (Chagas) infection; treatment with benznidazole is for the current infection episode; total authorized therapy duration for the current infection does not exceed 60 days; patient does not have Cockayne syndrome (contraindication).60 days

Age restriction has been removed; therapy limit applies per current infection.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider supplies sufficient documentation of efficacy and safety consistent with applicable off‑label use policies (e.g., HIM.PA.154 for health insurance marketplace or CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Use of benznidazole is contraindicated in patients with Cockayne syndrome. This contraindication was added because Cockayne syndrome is associated with a risk of irreversible and potentially fatal hepatotoxicity, and patients with this condition should not be treated with benznidazole.

Requests for benznidazole for indications not on the formulary or not listed in Section III must follow the health plan’s non‑formulary and off‑label use policies. For drugs not on the formulary or PDL, providers should refer to the applicable non‑formulary policies (HIMPA.103 for health insurance marketplace or CP.PMN.16 for Medicaid) or the off‑label use policies (HIM.PA.154 for health insurance marketplace or CP.PMN.53 for Medicaid); lacking satisfactory off‑label evidence or formulary coverage, such requests may be denied.

Therapy extending beyond the policy’s specified 60‑day authorization for the current infection episode is not supported by this policy and may be considered not medically necessary. Requests that exceed the 60‑day limitation are subject to denial.

Coding and Dosage Information

Affected codesmixed

affected codes

Placeholder for procedure/drug codes affected by prior authorization and duration limits (document references 'affected codes').

Maximum daily dose — 400 mg/day

Maximum daily dose400 mg/day

Dosing frequencyOral, twice daily (PO BID) as specified by weight-based regimen

Tablet strengths12.5 mg and 100 mg tablets available

Weight-based dosing referenceDose calculated by body weight per dosing table (see Dosage and Administration)

Therapy duration — 60 days

Therapy duration limit60 days total per current infection episode

Typical administration

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — initial and continued therapy require meeting specified diagnostic and treatment criteria and documentation. Requests must demonstrate member meets all approval criteria in the policy.

Prior authorization is required for initiation and continuation of benznidazole.
Approval requires submission of supporting clinical documentation (see documentation callout).
Approval duration for Chagas disease: up to 60 days total per current infection episode.

Documentation Required

Required Documentation

Provider must submit documentation (including office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Requests submitted without required supporting documentation or for non‑FDA uses lacking sufficient evidence may be delayed or denied.

Background

Benznidazole is a nitroimidazole antimicrobial indicated for treatment of Chagas disease (infection with Trypanosoma cruzi). The drug received FDA approval in pediatric patients aged 2 to 12 years under accelerated approval; clinical use and diagnostic confirmation align with CDC/WHO guidance and specialist consultation is recommended. Policy updates have removed age restrictions and established a 60‑day therapy limitation per current infection episode.

Definitions

T. cruzi definition

Taxonomic identificationTrypanosoma cruzi (T. cruzi)

Associated diseaseCausative agent of Chagas disease (American trypanosomiasis)

Reference sourcesDefined in appendices and FDA indication language within the policy document

IgG — immunoglobulin G antibody testing used for diagnosis and accelerated-approval endpoint

DefinitionImmunoglobulin G (IgG) serology: IgG antibody testing used for diagnosis and was the accelerated-approval endpoint for pediatric indication (becoming IgG antibody negative against T. cruzi recombinant antigens)

Role in approvalContinued FDA approval may be contingent on verification of clinical benefit after initial accelerated-approval based on IgG response

Policy Summary

PayerCentene

PolicyBenznidazole for Chagas disease

Policy CodePolicy CP.PMN.90

Change TypeMaterial coverage and operational revisions (age restriction removedtherapy limited to 60 daysnew contraindication added)

Effective DateMar 1, 2018

Next Review DateN/A

Key ActionSubmit prior authorization with supporting documentation (office notes, labs) demonstrating diagnostic confirmation and that treatment will not exceed 60 days for the current infection.

SourceLink

On This Page

Oral therapy administered PO BID for 60 days in Chagas disease dosing regimens

Authorization implicationPrior authorization approvals are limited to a 60-day treatment course

Include diagnostic test results (e.g., microscopy, PCR, and serologic tests) that meet the policy criteria.

Include documentation of prior benznidazole exposure and cumulative days of therapy for the current infection.

If request is for dose increase, include weight and rationale; weight‑based dose must not exceed 400 mg/day.

Step Therapy

Step Therapy / Alternatives

No formal step therapy is specified in this policy. Nifurtimox is referenced in the literature as a second‑line option when benznidazole intolerance occurs, but this policy does not mandate prior trial of nifurtimox before benznidazole.

No step edit enforced — do not require trial of alternative agents prior to authorization.
When benznidazole intolerance occurs, consider nifurtimox per clinical guidance and available evidence.

Note

Other Diagnoses / Off‑Label Uses

Requests for diagnoses/indications not addressed in this policy (non‑FDA or off‑label uses) must include sufficient documentation of efficacy and safety per applicable off‑label use policies (HIM.PA.154 for Marketplace; CP.PMN.53 for Medicaid) or other evidence of coverage documents. Absent adequate documentation, requests may be denied.

Other diagnoses/indications: authorization limited to 60 days for those requests unless otherwise supported by plan policies.
Follow state‑specific addendums for continuity of care where applicable.

Documentation Required

General Documentation and Coverage Governance

Coverage decisions follow the Health Plan's coverage documents and applicable state and federal requirements. This policy does not guarantee payment; benefits are subject to all terms, exclusions, and limitations of the member’s contract.

The clinical policy is an evidence‑review guidance tool and not a contract or guarantee of payment.
Adjudication is subject to plan benefit documents, state/federal law, and Health Plan administrative policies.

Denial Risk

Denial Risk: Documentation and Duration Limits

Denial risk: requests exceeding the 60‑day therapy limitation for the current infection, requests lacking required documentation, or requests for non‑FDA uses without sufficient evidence may be denied.

Therapy duration limit: maximum of 60 days total per current infection episode.
Requests missing supporting clinical documentation are at high risk for denial.

Use in diagnosisTwo positive serologic IgG tests using different techniques and antigens can confirm diagnosis per policy criteria

Chagas disease definition — infection by Trypanosoma cruzi; chronic infection sequelae

DefinitionChagas disease (American trypanosomiasis): infection caused by Trypanosoma cruzi

Clinical sequelaeChronic infection can lead to cardiomyopathy and other long-term complications

Treatment contextBenznidazole is indicated for treatment of Chagas disease; diagnostic confirmation options include microscopy, serology, or PCR per policy