CurrentCentenePolicy CP PHAR.352

Daunorubicin/Cytarabine (Vyxeos)

Covers medical necessity and prior authorization criteria for Vyxeos (liposomal daunorubicin/cytarabine) for treatment of newly-diagnosed therapy-related AML, AML with myelodysplasia-related changes, and antecedent MDS/CMML in eligible members; applies to Centene-affiliated health plans across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyDaunorubicin/Cytarabine (Vyxeos)

Policy CodePolicy CP PHAR.352

Change TypeNo material changes

Effective DateDec 1, 2017

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, oncologist/hematologist involvement, age, and dosing consistent with induction or consolidation regimens.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Up to 2Allowed induction cycles

Up to 2Allowed consolidation cycles

6 monthsAuthorization length

J9153HCPCS code

Coverage Criteria

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Diagnosis: Member has a diagnosis of newly-diagnosed therapy-related acute myeloid leukemia (t-AML), acute myeloid leukemia with myelodysplasia-related changes (AML-MRC), or antecedent myelodysplastic syndrome/chronic myelomonocytic leukemia (MDS/CMML)

See Appendix A for definitions

Prescriber: Prescribed by or in consultation with an oncologist or hematologist

Age: Member is at least 1 year of age>= 1 year

Pediatric extension applies from 1 year and older

Treatment intent and dosing: Request is for either induction (up to 2 cycles) or consolidation (up to 2 cycles) with doses not exceeding specified liposomal daunorubicin and cytarabine amounts per regimenInduction: daunorubicin liposomal 44 mg/m2 and cytarabine liposomal 100 mg/m2 on days 1,3,5 for first induction (days 1 and 3 if second induction); Consolidation: daunorubicin liposomal 29 mg/m2 and cytarabine liposomal 65 mg/m2 on days 1 and 3

Second induction only if no response to first induction; timing and intervals per dosing guidance

Supporting evidence for off-label dosing: If dose or use is off‑label, the dose or regimen must be supported by practice guidelines or peer‑reviewed literature and prescriber must submit supporting evidence

Prescribed regimen must be FDA‑approved or recommended by NCCN

Continuation Therapy

For continued therapy

Current therapy: Member is currently receiving Vyxeos via the Centene benefit and has received it for at least 30 days

Documentation required

Response: Member is responding positively to therapy

Treatment count: Member has not received more than 4 total treatment cycles (up to 2 induction and up to 2 consolidation)<= 4 cycles

Dose change: If request is for a dose increase, the new dose must not exceed the maximum specified per induction or consolidation regimens or must be supported by practice guidelines/peer‑reviewed literature with prescriber submission of supporting evidenceInduction max: daunorubicin 44 mg/m2 & cytarabine 100 mg/m2; Consolidation max: daunorubicin 29 mg/m2 & cytarabine 65 mg/m2

Prescriber must submit supporting evidence for off‑label dose increases

Requests for indications that are not FDA‑approved and not addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (for example, HIMPA.154 for Health Insurance Marketplace or CP.PMN.53 for Medicaid) or the member’s evidence of coverage documents. Such documentation should align with the off‑label use requirements cited in the referenced policies.

Use of Vyxeos for indications that are not listed in this policy and for which the provider has not supplied adequate off‑label supporting documentation may be considered not medically necessary. Providers should follow the referenced off‑label use policies and submit peer‑reviewed literature or guideline support when requesting coverage for off‑label uses.

Covered Regimens and Dosing

Regimen	Dosing / Schedule	Second induction timing
{"text":"Induction (first): daunorubicin liposomal + cytarabine liposomal","status":""},{"text":"Daunorubicin 44 mg/m2 + cytarabine 100 mg/m2 IV over 90 minutes on days 1, 3, and 5","status":""},{"text":"If no response to first induction, second induction: daunorubicin 44 mg/m2 + cytarabine 100 mg/m2 IV over 90 minutes on days 1 and 3, administered 2–5 weeks after the first induction","status":""}

Regimen	Dosing / Schedule	Consolidation timing
{"text":"Consolidation","status":""},{"text":"Daunorubicin liposomal 29 mg/m2 + cytarabine liposomal 65 mg/m2 IV over 90 minutes on days 1 and 3","status":""},{"text":"First consolidation: 5–8 weeks after the start of the last induction; second consolidation: 5–8 weeks after the start of the first consolidation","status":""}

Product	Covered indications	Coverage status
{"text":"Daunorubicin/cytarabine (liposomal)","status":""},{"text":"Therapy-related acute myeloid leukemia (t-AML); acute myeloid leukemia with myelodysplasia-related changes (AML-MRC); antecedent myelodysplastic syndrome / chronic myelomonocytic leukemia (MDS/CMML)","status":""},{"text":"Covered with criteria","status":"covered"}

Coding

HCPCS CodesHCPCS

J9153

Injection, liposomal, daunorubicin and cytarabine

Referenced HCPCS CodesHCPCS

J9153	Injection, liposomal
C9024	Temporary HCPCS code removed (referenced as removed in update)

Age — minimum age requirement

Minimum ageMember is at least 1 year of age

Pediatric applicabilityPediatric extension applies from 1 year and older

Documentation requirementPrescriber must document age in prior authorization request

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for Vyxeos (liposomal daunorubicin/cytarabine, HCPCS J9153). Requests must include clinical documentation supporting medical necessity.

Request must specify diagnosis (t-AML, AML-MRC, or AML with antecedent MDS/CMML) and member age.
Prescriber is an oncologist or hematologist or request is in consultation with one.
Documentation must include relevant office chart notes, pathology reports, and laboratory results (e.g., bone marrow biopsy, cytogenetics) supporting the indication and treatment plan.
Specify whether the request is for induction or consolidation and the planned dosing schedule.

Prior Authorization

Prior Authorization — Liposomal Daunorubicin/Cytarabine (J9153)

Prior authorization and coverage determinations for liposomal daunorubicin/cytarabine (J9153) will follow the medical necessity criteria in this policy (indication, prescriber specialty, age, and dosing limits).

HCPCS J9153 (Injection, daunorubicin and cytarabine liposomal) is the drug-specific code referenced for prior authorization and claims submission.
Approval for induction: up to 2 induction cycles (dose limits per cycle detailed in policy).
Approval for consolidation: up to 2 consolidation cycles (dose limits per cycle detailed in policy).

Documentation Required

Induction/Consolidation Regimen Structure

Induction and consolidation regimen structure and dosing limits must be documented and adhered to for approval.

Induction: up to 2 cycles. Typical first induction: daunorubicin liposomal 44 mg/m2 and cytarabine liposomal 100 mg/m2 IV over 90 minutes on days 1, 3, and 5. A second induction (for lack of response) may be given on days 1 and 3 at the same per-dose limits, administered 2–5 weeks after the first induction if clinically appropriate.
Consolidation: up to 2 cycles. Typical consolidation: daunorubicin liposomal 29 mg/m2 and cytarabine liposomal 65 mg/m2 IV over 90 minutes on days 1 and 3, administered 5–8 weeks after the start of the prior cycle when indicated.
Per-cycle dose maxima: approval requires doses not to exceed the regimen-specific mg/m2 limits noted above; prescriber must document any deviation with supporting literature or guideline rationale.

Denial Risk

Non‑Authorized Indications

Coverage limitations and non‑authorized indications.

Requests for non‑FDA approved (off‑label) indications that are not addressed in this policy are not authorized unless the prescriber submits sufficient supporting evidence of efficacy and safety per the plan's off‑label use requirements (see applicable off‑label policies).
Coverage for off‑label use may be considered only with strong peer‑reviewed literature or guideline support; prescriber must include references when requesting such use.

Billing Rule

Coding Does Not Guarantee Coverage

Coding inclusion is informational only and does not guarantee coverage; providers must use current coding guidance when submitting claims.

Codes referenced in this policy (for example, HCPCS J9153) are provided for convenience. Inclusion or exclusion of codes does not ensure coverage.
Providers should reference the most up‑to‑date professional coding resources when billing and submitting claims for reimbursement.

Note

Coverage Governed by Member Contract

Coverage decisions are governed by the member's contract and applicable laws and plan-level policies.

Approval of therapy is subject to the terms, conditions, exclusions, and limitations of the member's evidence of coverage, certificate of coverage, policy or contract.
State and federal requirements and Health Plan administrative policies and procedures also apply; this clinical policy does not guarantee payment or override contract language.

Definitions

therapy-related acute myeloid leukemia (t-AML) definition

Definition (term)Therapy-related acute myeloid leukemia (t-AML)

Source noteListed in Appendix A as 't-AML: therapy-related acute myeloid leukemia'

Coverage contextIncluded as a covered diagnosis for Vyxeos induction and consolidation per dosing guidance

acute myeloid leukemia with myelodysplasia-related changes (AML-MRC) definition

Definition (term)Acute myeloid leukemia with myelodysplasia-related changes (AML-MRC)

Source noteListed in Appendix A as 'AML-MRC: acute myeloid leukemia with myelodysplasia-related changes'

Coverage contextIncluded as a covered diagnosis for Vyxeos induction and consolidation per dosing guidance

myelodysplastic syndrome / chronic myelomonocytic leukemia (MDS/CMML) definition

Definition (term)Myelodysplastic syndrome / chronic myelomonocytic leukemia (MDS/CMML)

Source noteAppendix A lists 'MDS-CMLL: myelodysplastic syndromel chronic myelomonocytic leukemia' (document spelling variant)

Coverage contextAntecedent MDS/CMML is included as a covered diagnosis for Vyxeos regimens

Line of Therapy

first-line

Line: Induction: first‑line induction (up to 2 cycles); second induction only for failure to achieve response with the first induction (administer 2–5 weeks after first induction). Consolidation: post‑induction consolidation up to 2 cycles (first consolidation 5–8 weeks after last induction; second consolidation 5–8 weeks after first consolidation)

Dosing and timing specified in dosing regimen

Background

Vyxeos is a liposomal fixed‑combination formulation of daunorubicin and cytarabine designed to deliver both agents together. The product is FDA‑approved for treatment of newly‑diagnosed therapy‑related acute myeloid leukemia (t‑AML) and acute myeloid leukemia with myelodysplasia‑related changes (AML‑MRC), including pediatric patients aged 1 year and older. Typical administration and dosing regimens (induction and consolidation cycles) are specified in the prescribing information and this policy’s regimen tables.