ModifiedCentenePolicy N/A

Clinical Policy: Dexrazoxane (Totect)

This policy governs medical necessity criteria, dosing, and authorization for dexrazoxane (Totect) for reduction of doxorubicin-related cardiomyopathy and treatment of anthracycline extravasation for members covered by Centene lines of business.

Policy Summary

PayerCentene

PolicyClinical Policy: Dexrazoxane (Totect)

Policy CodePolicy N/A

Change TypeMaterial revisions (product discontinuation, indication updates, coding changes)

Effective Date03.19.19

Next Review DateMay 25, 2025

Key ActionSubmit prior authorization with documentation showing member meets the approval criteria, including indication, cumulative doxorubicin dose, and prescriber specialty.

SourceLink

POLICY UPDATE CHANGES

Removed brand Totect from criteria as discontinued; clarified anthracycline extravasation is now off-label without Totect; removed Hodgkin lymphoma age-based criterion and removed redirections now that product is only available generic.

For doxorubicin-induced cardiomyopathy, added redirection to generic dexrazoxane and added NCCN 2A indications including relapsed/refractory Ph-positive ALL and Hodgkin lymphoma in adults.

Updated FDA approved indication to mirror product PI and clarified pediatric limitations for certain diagnoses; added off-label use for soft tissue sarcoma per NCCN 2A.

Updated coding references for HIM line of business off-label use from HIM.PHAR.2I to HIM.PA.154 and adjusted dosing section to include Totect for doxorubicin-induced cardiomyopathy (historical note).

12 monthstypical approval duration for cardioprotection

3 daysapproval duration for extravasation

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Coverage Criteria for Dexrazoxane

Initial Approval — Doxorubicin-Induced Cardiomyopathy

Covered when ALL of the following are met:

Cardioprotection initial criteria: 1) Prescribed to reduce the incidence or severity of cardiomyopathy associated with doxorubicin; 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Age criteria: adults >18 years for the FDA adult indication OR pediatric indications supported by NCCN (see pediatric regimen guidance); 4) Member has received a cumulative doxorubicin dose meeting the applicable threshold (e.g., >= 300 mg/m2 for the adult FDA cardioprotection indication; pediatric thresholds vary by diagnosis per policy); 5) Will be used concurrently with doxorubicin and the dexrazoxane dose is appropriate relative to the doxorubicin dose (policy example: dexrazoxane 500 mg for doxorubicin 50 mg or other guideline-supported dosing); 6) Prescribed regimen is FDA-approved for the indication or recommended by NCCN (including referenced pediatric protocols).see node text

Approval duration: 12 months or duration of doxorubicin therapy, whichever is less

Initial Approval — Anthracycline-Induced Extravasation (off-label)

Covered when ALL of the following are met:

Extravasation initial criteria: 1) Diagnosis of anthracycline-induced extravasation; 2) Prescribed by or in consultation with an oncologist; 3) Age >= 18 years; 4) Requested dexrazoxane dose does not exceed the policy-specified maximums (policy lists dose limits e.g., up to 2,000 mg in certain contexts and 1,000 mg in others as applicable); 5) Prescriber provides documentation supporting the extravasation diagnosis and intended short-term use.dose limits per policy

Approval duration: 3 days

Indications updated — Policy coverage updated to reflect FDA PI and NCCN 2A recommendations and product availability effect on labeled vs off-label use

Policy coverage updated to reflect FDA PI and NCCN 2A recommendations for select indications; product availability affects labeled vs off-label status.

Updated indications: Includes updated FDA PI indications and NCCN 2A supported uses; clarified pediatric limitations for select diagnoses; added and later revised certain NCCN 2A off-label indications (for example, soft tissue sarcoma; relapsed/refractory Ph-positive ALL; Hodgkin lymphoma adult references updated/removed over time); product availability changes (removal of brand Totect) affect whether extravasation use is labeled versus off-label.

Specific medical necessity criteria, age thresholds, and exact listing changes are described in the initial approval and line-of-therapy sections of the policy.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies: CPA.09 for commercial lines, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or unless the indication is otherwise supported by the member's evidence of coverage documents.

The brand product Totect has been removed from the criteria because it is discontinued and obsolete. As a result, the policy clarifies that treatment of anthracycline‑induced extravasation is now considered an off‑label use in the absence of the branded product and related labeling.

Uses that are non‑FDA approved and are not supported by the documentation requirements or the referenced off‑label use policies (CPA.09, HIM.PA.154, CP.PMN.53) are not authorized under this policy.

Within the provided document excerpts there are no explicit statements declaring any uses of dexrazoxane as 'not medically necessary.' Coverage determinations remain subject to the policy criteria, documentation requirements, and the member's coverage documents and regulatory requirements.

Regimen / Protocol	Indication / Rationale	Coverage Status
{"text":"DFCI ALL protocols (e.g., DFCI ALL Protocol 11-001, 16-001)","status":""}\|{"text":"Pediatric Ph‑negative ALL with anticipated cumulative anthracycline exposure >= 250 mg/m2 (use per protocol to reduce cardiomyopathy risk)","status":"covered"}\|{"text":"","status":"covered"}
{"text":"COG regimens (e.g., AALL1131/AALL1331 contexts referenced)","status":""}\|{"text":"Pediatric regimens where planned cumulative doxorubicin dose meets pediatric thresholds (e.g., ≥150–250 mg/m2 depending on diagnosis) and NCCN‑supported indications","status":"covered"}\|{"text":"","status":"covered"}

Product / Drug	Indication / Notes	Coverage Status
{"text":"Dexrazoxane (generic; Totect historically referenced)","status":""}\|{"text":"Management/prevention of anthracycline‑related cardiomyopathy consistent with FDA PI for adult indication and NCCN 2A recommendations for select indications; pediatric limitations and specific indications per protocol/NCCN apply. Totect brand removed as discontinued (product now generic).","status":"covered"}\|{"text":"","status":"covered"}

Coding and Dose Thresholds

HCPCS CodesHCPCS

J1900

Injection, dexrazoxane hydrochloride, per 250 mg

Policy references / internal codingmixed

HIM.PA.154

HIM line of business off-label use reference (updated from HIM.PHAR.2I)

Cumulative doxorubicin dose — adult cardioprotection

Adult cumulative doxorubicin dose threshold>= 300 mg/m2

Approval contextFDA adult cardioprotection indication for women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and will continue doxorubicin therapy

Timing relative to doxorubicinDo not use at doxorubicin initiation; intended for continuation when cumulative dose threshold met

Pediatric cumulative doxorubicin dose thresholds (by diagnosis)

Pediatric ALL (DFCI protocols)>= 250 mg/m2 (anticipated cumulative anthracycline dose per protocol)

Wilms tumor (nephroblastoma)

Provider Actions, Authorization & Documentation

Prior Authorization

Prior authorization routing and coding note

Prior authorization is required. Requests must be routed through the Health Plan’s prior authorization process and include coding that reflects the requested indication and administration (e.g., dexrazoxane for doxorubicin-induced cardiomyopathy or anthracycline extravasation). Policy and coding updates (including changes to product availability and line-of-business references) may affect routing and applicable PA forms or code sets — providers should use the most current Health Plan PA submission channels and code the request to match the clinical indication.

Ensure PA submission includes indication-specific coding and administration route.
Verify product availability (brand vs generic) when selecting NDC/HCPCS; recent removals (e.g., Totect, Zinecard) may change billing codes.

Denial Risk

Documentation and indication gaps — risk of incomplete or denied requests

Provider must submit complete clinical documentation to support that the member meets all approval criteria. Incomplete requests lacking required documentation (office notes, oncology/hematology consultation notes, cumulative doxorubicin dosing records, lab results, or other relevant clinical records) may be returned as incomplete or denied.

Definitions & Administration

Dexrazoxane — definition and clinical role

DefinitionDexrazoxane: a cytoprotective agent used to reduce anthracycline-associated cardiotoxicity and to treat anthracycline extravasation.

Primary FDA cardioprotection indication (historical branded product Totect)Reduction of incidence and severity of cardiomyopathy associated with doxorubicin administration.

Role in oncology careUsed for cardioprotection when cumulative anthracycline exposure is high and for treatment of anthracycline extravasation; policy references NCCN-supported pediatric uses and evolving product availability.

Administration timing and preparation

Administration timing for cardioprotectionIV infusion over 15 minutes within 30 minutes before doxorubicin administration

Dose ratio guidance

Continuation and Subsequent Therapy

Continuation — continuation criteria

Continued therapy (continuation): Member continues to meet the original approval criteria for doxorubicin-induced cardioprotection; member is continuing on doxorubicin therapy and cumulative doxorubicin dose thresholds and indication remain appropriate for ongoing dexrazoxane use.

Approval duration continuation aligned with initial approval (up to 12 months or duration of doxorubicin therapy, whichever is less).

Second-line — second-line criteria, 1 top-level node

Second-line references: Policy references NCCN 2A indications including relapsed/refractory Ph-positive ALL and select Hodgkin lymphoma adult indications (as of 2Q 2024); second-line use should meet the specific NCCN-supported indication and documented clinical rationale per policy.

Line-of-therapy specifics and any age-based modifications are in the policy history and indication sections; verify current NCCN and policy language when authorizing.

Background

Dexrazoxane is a cytoprotective agent used to reduce the incidence and severity of cardiomyopathy associated with doxorubicin and to treat anthracycline extravasation. The policy references FDA labeling and NCCN guidance for cardioprotection and pediatric indications, and notes that product availability changes (e.g., removal of the Totect brand) have impacted labeled versus off‑label status for certain extravasation indications.

Covered Regimens and Protocols

Pediatric Regimen / Protocol	When to Use (thresholds / rationale)	Coverage Status
{"text":"DFCI ALL Protocols (example: Protocol 11‑001, 16‑001)","status":""}\|{"text":"When anticipated cumulative anthracycline (doxorubicin‑equivalent) dose ≥ 250 mg/m2 or per protocol‑specified threshold; use as specified in pediatric protocols to reduce cardiomyopathy risk","status":"covered"}\|{"text":"","status":"covered"}
{"text":"COG pediatric regimens (examples cited in policy)","status":""}\|{"text":"Use when cumulative doxorubicin planned meets diagnosis‑specific pediatric thresholds (e.g., Wilms tumor ≥150 mg/m2; certain sarcomas ≥250 mg/m2) and per NCCN‑recommended protocols","status":"covered"}\|{"text":"","status":"covered"}

Intervention	Clinical Context / Limitations	Coverage Status
{"text":"Dexrazoxane (generic; formerly Totect brand)","status":""}\|{"text":"Used for cardioprotection with doxorubicin per FDA PI (adult indication) and per NCCN 2A for select indications (includes certain pediatric uses with limitations). Policy notes pediatric limitations by diagnosis and evolving indications; Totect brand removed as discontinued and extravasation indication is off‑label without Totect.
status":"covered"}\|{"text":"","status":"covered"}

Policy Summary

PayerCentene

PolicyClinical Policy: Dexrazoxane (Totect)

Policy CodePolicy N/A

Change TypeMaterial revisions (product discontinuation, indication updates, coding changes)

Effective Date03.19.19

Next Review DateMay 25, 2025

Key ActionSubmit prior authorization with documentation showing member meets the approval criteria, including indication, cumulative doxorubicin dose, and prescriber specialty.

SourceLink

On This Page

Documentation Required

Documentation and state precedence

Coverage and PA determinations are subject to the member’s benefit terms and any applicable state or federal requirements. For Medicaid members, state Medicaid coverage provisions prevail when in conflict with this clinical policy. Follow Health Plan administrative policies and the applicable line‑of‑business off‑label or formulary policies referenced in this policy when preparing documentation and submissions.

Adhere to line‑of‑business policies for formulary/non‑formulary and off‑label routing (see policy references such as CP.CPA.190, HIM.PA.154/HIM.PA.103, CP.PMN.53/CP.PMN.16 as applicable).
When state Medicaid rules conflict with this policy, follow the state Medicaid manual and state provisions.

Dexrazoxane — off-label use and product availability

Off-label status due to product discontinuationAnthracycline-induced extravasation is now considered an off-label use after removal of brand Totect from criteria (product discontinued).

Example off-label uses referencedNCCN 2A supported indications (e.g., select pediatric regimens, soft tissue sarcoma) may be considered per policy and supporting evidence.

Documentation requirement for off-label usePrescriber must submit supporting evidence for relevant off-label uses as required by the policy (see prior authorization and off-label routing).