CurrentViva HealthPolicy IC-0314

Vyxeos (daunorubicin and cytarabine liposome) prior authorization and coverage

Clinical policy describing prior authorization, coverage criteria, dosing, billing codes, and authorization limits for Vyxeos for treatment of certain acute myeloid leukemia (AML) diagnoses for Viva Health members.

Policy Summary

PayerViva Health

PolicyVyxeos (daunorubicin and cytarabine liposome) prior authorization and coverage

Policy CodePolicy IC-0314

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization valid for up to 2 induction cycles (5 doses total) and 2 consolidation cycles (4 doses total) within 180 days; renewal is not permitted.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 ind + 2 conmax prior auth validity

1012max billable units

J9153HCPCS

68727-0745-xxNDC

2017-2026review history

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Approval - AML indications and general criteria

Covered when ALL of the following are met:

General eligibility: Member is at least 1 year of age (unless otherwise specified); baseline left ventricular ejection fraction (LVEF) is within normal limits and will be reassessed prior to consolidation and as clinically required; cumulative lifetime anthracycline dose does not exceed 550 mg/m2 (or 400 mg/m2 in members who received radiation to the mediastinum); will not be used in combination with other chemotherapy.

Indications - AML subtypes and settings: Member has therapy-related acute myeloid leukemia (t-AML) OR cytogenetic changes consistent with myelodysplasia (previously classified as AML-MRC) OR antecedent myelodysplastic syndrome/chronic myelomonocytic leukemia (MDS/CMML) OR poor-risk AML (with or without TP53 mutation or del17p)

FDA-approved indications and compendia-recommended indications apply

Therapy setting: Used as induction therapy for newly diagnosed disease OR used as re-induction therapy after cytarabine-based induction therapy OR used as consolidation therapy.

For antecedent MDS/CMML and poor-risk AML, member must be at least 18 years of age for certain settings as specified in policy

Renewal

Renewal criteria

Renewal: Duration of authorization has not been exceeded (refer to Section I).

Authorization may not be renewed per policy Section I

Regimen	Daunorubicin (mg/m2)	Cytarabine (mg/m2)	Schedule / Days	Cycles / Timing	Coverage status
Induction (first induction) - applies to t-AML, antecedent MDS/CMML, or cytogenetic changes consistent with MDS (AML-MRC)
44
100
Intravenous on days 1, 3, and 5
1 cycle
Covered when criteria met (see coverage criteria)

Use of Vyxeos in combination with other chemotherapy is excluded. Coverage requires that the member's cumulative lifetime anthracycline dose does not exceed 550 mg/m2, or 400 mg/m2 for members who received mediastinal radiation. Additional eligibility requirements include age and cardiac function criteria described elsewhere in the policy.

Prior authorization is required. Initial authorization is valid for a maximum of 2 induction cycles (5 doses total) and 2 consolidation cycles (4 doses total) within 180 days (6 months). Per policy, requests that would exceed these duration limits or requests for renewal after that period are considered not medically necessary and prior authorization may not be renewed.

Billing and Coding

HCPCS CodeHCPCSCovered

J9153

Injection, liposomal, 1 mg daunorubicin and 2.27 mg cytarabine; 1 billable unit = 1 mg daunorubicin and 2.27 mg cytarabine

NDCNDC

68727-0745-xx

Vyxeos (44 mg daunorubicin and 100 mg cytarabine) liposome, single-dose vial

Covered ICD-10 CodesICD-10Covered

C92.00	Acute myeloblastic leukemia not having achieved remission
C92.01	Acute myeloblastic leukemia in remission
C92.50	Acute myelomonocytic leukemia not having achieved remission
C92.51	Acute myelomonocytic leukemia in remission
C92.60	Acute myeloid leukemia with 11q23-abnormality not having achieved remission
C92.61	Acute myeloid leukemia with 11q23-abnormality in remission
C92.A0	Acute myeloid leukemia with multilineage dysplasia not having achieved remission
C92.A1	Acute myeloid leukemia with multilineage dysplasia in remission
C93.00	Acute monoblastic/monocytic leukemia not having achieved remission
C93.01	Acute monoblastic/monocytic leukemia in remission

inv-08: Minimum age

Minimum age (general)Member is at least 1 year of age (unless otherwise specified).

Minimum age (antecedent MDS/CMML)Member must be at least 18 years of age for antecedent MDS/CMML indications.

Minimum age (poor‑risk AML)Member must be at least 18 years of age for poor‑risk AML indications (including with or without TP53‑mutation or del17p).

Provider Actions, Documentation & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Validity is limited to a maximum of 2 induction cycles (5 doses total) and up to 2 consolidation cycles (4 doses total) within 6 months (180 days). Prior authorization renewal is not permitted.

Initial: up to 2 induction cycles and 2 consolidation cycles within 180 days
Renewal: prior authorization may not be renewed

Step Therapy

Step Therapy / Indication Context

Step therapy applies to specific AML populations and therapy-line contexts. Coverage is for: newly diagnosed therapy-related AML (t-AML) or AML with cytogenetic changes consistent with MDS (formerly AML-MRC) when used as induction therapy; re-induction after failure of cytarabine-based induction therapy; and consolidation therapy. For members with antecedent MDS/CMML, use is limited to adults (≥18 years) as induction (for those eligible for intensive induction), re‑induction after cytarabine-based induction with residual disease, or consolidation.

Populations: t-AML, AML-MRC (cytogenetic changes consistent with MDS), antecedent MDS/CMML, poor‑risk AML (with or without TP53/del17p)
Therapy-line context: induction for newly diagnosed disease; re‑induction after cytarabine-based induction failure; consolidation therapy

Documentation Required

Required Documentation and Potential Denial Triggers

Document and confirm the following prior to approval; absence or abnormality may trigger denial.

Age eligibility: member ≥1 year of age unless otherwise specified; antecedent MDS/CMML and poor‑risk AML indications restricted to members ≥18 years
Baseline LVEF: documented within normal limits with plan for reassessment prior to consolidation and as clinically indicated — abnormal baseline LVEF may trigger denial
Cumulative anthracycline dose: documented lifetime cumulative dose ≤550 mg/m2 (≤400 mg/m2 if prior mediastinal radiation) — exceeding limits may trigger denial
Concomitant therapy: will not be used in combination with other chemotherapy — combination use may trigger denial
Intended use: state whether request is for induction (first induction), re‑induction (second induction after cytarabine-based induction failure), or consolidation

Regimen	Daunorubicin (mg/m2)	Cytarabine (mg/m2)	Schedule / Days	Cycles / Timing	Coverage status
Re-induction (second induction) — only for members who fail to respond to first induction; may be given 2–5 weeks after first induction if tolerated
44
100
Intravenous on days 1 and 3
1 cycle; administer 2–5 weeks after first induction if no unacceptable toxicity
Covered when criteria met (see coverage criteria)

Biomarker and Genetic Considerations

inv-16: TP53 mutation / del17p

Biomarker notedTP53‑mutation or del17p is referenced as part of the poor‑risk AML subgroup (coverage applies with or without these abnormalities).

Role in indicationPresence of TP53 mutation or del17p classifies disease as poor‑risk AML for which coverage criteria apply (age and setting requirements also apply).

Testing expectationPolicy references TP53 mutation/del17p as a distinguishing poor‑risk feature but does not mandate it as an isolated requirement for coverage—coverage may apply with or without these abnormalities.

Disease Subtype Definitions

inv-14: Disease subtype definitions

t-AML definitionTherapy‑related acute myeloid leukemia (t‑AML) — cited as an FDA‑approved indication for coverage when used in the specified therapy settings (induction, re‑induction, consolidation).

AML‑MRC definitionAcute myeloid leukemia with cytogenetic changes consistent with myelodysplasia (previously classified as AML‑MRC) — included as a covered subtype for the specified therapy settings.

Antecedent MDS/CMMLAML arising after antecedent myelodysplastic syndrome or chronic myelomonocytic leukemia (antecedent MDS/CMML) — coverage permitted when member is ≥18 years and therapy setting criteria are met.