CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vyxeos (daunorubicin and cytarabine liposomal) coverage

Defines medical necessity criteria, coding, exclusions, and authorization requirements for Vyxeos for treatment of specific acute myeloid leukemia (AML) populations for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVyxeos (daunorubicin and cytarabine liposomal) coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 27, 2024

Next Review DateDec 12, 2024

Key ActionObtain prior authorization for Vyxeos; continuation requests may be exempt if the medication was used within the last year without progression or intolerance and no additional medications are added.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9153billing HCPCS code for Vyxeos

5allowed newly diagnosed AML subtypes

60+ & 1-17age groups covered

single-dose limitsdose limits

Coverage Criteria for Vyxeos

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Initial Therapy (Induction and Consolidation)

Covered when ALL of the following are met for newly diagnosed AML induction/consolidation in adults aged 60+ or pediatric patients 1-17:

Primary eligibility

Allowed AML subtypes (one required): Member has one of the following AML subtypes: (a) therapy-related AML; (b) AML with a history of MDS without prior hypomethylating agent (HMA) therapy; (c) AML with a history of MDS treated with prior HMA; (d) AML with a history of chronic myelomonocytic leukemia (CMML); (e) de novo AML with MDS-related cytogenetic abnormalitiesone of five subtypes
See list a–e in policy

Exclusions from coverage include members who do not have one of the five specified AML subtypes required by the indication, and members with acute promyelocytic leukemia (APL) or core binding factor AML (t(8;21) or inv(16)). Requests for patients with CNS leukemia are also excluded. Coverage will be denied when dosing exceeds the stated single‑dose limits: Induction — 44 mg/m2 daunorubicin liposomal and 100 mg/m2 cytarabine liposomal; Consolidation — 29 mg/m2 daunorubicin liposomal and 65 mg/m2 cytarabine liposomal. Investigational or off‑label uses that lack sufficient evidence according to CMS‑recognized compendia or acceptable peer‑reviewed literature are considered not covered.

Use of Vyxeos for indications or patient populations without adequate supporting evidence is considered not medically necessary. The policy requires supportive evidence that meaningfully represents the patient population and treatment regimen and demonstrates clinically meaningful outcomes (for example, survival benefits consistent with commonly accepted thresholds). Uncontrolled case reports, anecdotal series, or meeting abstracts without a full peer‑reviewed publication do not provide sufficient evidence and therefore do not meet the policy’s standards for coverage.

Initial Therapy — Induction and Consolidation

Initial therapy — induction and consolidation coverage criteria

Induction and consolidation coverage criteria for Vyxeos (daunorubicin and cytarabine liposomal):

Age and subtype requirements: Adult members aged 60 years or older with newly diagnosed AML OR pediatric members aged 1–17 with therapy-related AML or AML with MDS-associated cytogenetic abnormalitiesage and subtype

Vyxeos is not supported as induction treatment in adult members <60 years of age per policy

Allowed AML subtypes (one required): One of: therapy-related AML; AML with history of MDS without prior HMA; AML with history of MDS treated with prior HMA; AML with history of CMML; de novo AML with MDS-related cytogenetic abnormalitiesone of five subtypes

list a–e in policy

Continuation (Re-authorization) Criteria

Continuation requests — re-authorization allowance and conditions

Continuation (re-authorization) allowance — requests may be exempt from full prior authorization when ALL of the following are met:

Continuation exemption: Requested medication was used within the last year AND the member has not experienced disease progression or intolerance AND no additional medications are being added to the continuation requestcontinuation conditions

If all conditions are met the continuation request is exempt from policy per continuation rules

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vyxeos (daunorubicin and cytarabine liposomal) requests. Continuation (refill) requests are exempt from prior authorization under the following conditions: the medication was used within the last year; the member has not experienced disease progression or intolerance to the medication; and no additional medications are being added to the continuation request.

Prior authorization required for new starts
Continuation requests exempt if all continuation conditions met

Step Therapy

Step therapy sequencing: no specific step-therapy agents or required prior regimens are specified for Vyxeos. There is no mandated trial of alternative agents before authorization when the member meets the clinical inclusion criteria for Vyxeos.

No specified step-therapy agents or sequence
Authorization may be considered when clinical criteria are met without prior trials

Documentation Required

Required Supporting Documentation

Required supporting documentation must reference one or more of the following: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards. Documentation should support the requested indication (including AML subtype), dosing, and prior treatment history where applicable.

Cite FDA labeling, CMS compendia, NCCN or ASCO guidelines, or qualifying peer-reviewed literature
Include documentation of AML subtype, prior therapies (e.g., prior HMA), and dosing details

Denial Risk

Denial Triggers

Denial triggers include requests for indications or patient populations excluded by policy (e.g., AML subtypes not listed in inclusion criteria, acute promyelocytic leukemia, core binding factor AML such as t(8;21) or inv(16)), CNS leukemia, dosing that exceeds single-dose limits, or investigational/off-label uses lacking sufficient evidence in recognized compendia or acceptable peer‑reviewed literature.

Requests for APL or core binding factor AML (t(8;21) or inv(16))
Indications not among the five AML subtypes listed in inclusion criteria
CNS leukemia
Dosing above specified single-dose limits
Off-label or investigational uses without CMS compendia or acceptable peer-reviewed support

Quantity Limits and Dosing

Vyxeos (daunorubicin and cytarabine liposomal) — induction/consolidation dosing and quantity limits

Covered HCPCS codeJ9153 — Injection, liposomal, mg daunorubicin and 2.27 mg cytarabine

Induction single-dose maximums44 mg/m2 daunorubicin liposomal; 100 mg/m2 cytarabine liposomal

Consolidation single-dose maximums29 mg/m2 daunorubicin liposomal; 65 mg/m2 cytarabine liposomal

Quantity-limit contextLimits apply per single dose within an induction or consolidation course as stated in policy; dosing that exceeds these single-dose limits is listed as an exclusion

Definitions

Therapy-related AML — definition

DefinitionTherapy-related AML — AML that arises as a consequence of prior cytotoxic chemotherapy or radiotherapy (listed as 'therapy related AML' in policy)

Policy useListed as an allowed subtype for Vyxeos induction and consolidation in adults ≥60 and in pediatric patients 1–17

Citation noteSee policy Section B.1.a for inclusion under permitted AML subtypes

AML with history of MDS — definition

DefinitionAML with history of MDS — AML occurring in a patient with prior myelodysplastic syndrome; policy distinguishes prior HMA treatment status (no prior HMA vs treated with prior HMA)

Policy useIncluded as an allowed subtype for Vyxeos induction and consolidation in adults ≥60 and in select pediatric patients

Treatment distinctionPolicy specifically lists both 'No prior HMA' and 'Treated with prior HMA' as separate subcategories

AML with history of CMML — definition

DefinitionAML with history of CMML — AML occurring in a patient with prior chronic myelomonocytic leukemia (CMML)

Policy useListed as one of the five allowed newly diagnosed AML subtypes for Vyxeos in adults ≥60

PlacementSee policy Section B.1.d for inclusion criteria

Core binding factor AML — defined by t(8;21) or inv(16)

DefinitionCore binding factor (CBF) AML — AML positive for t(8;21) or inversion 16 (inv(16))

Policy implicationCBF AML (t(8;21) or inv(16)) is listed as an exclusion to Vyxeos use in this policy

ReferenceSee Exclusion Criteria and Section B for core binding factor specification

Background

Vyxeos (daunorubicin and cytarabine liposomal) is a fixed liposomal combination of an anthracycline and cytarabine formulated for use in certain acute myeloid leukemia populations. This policy aligns Vyxeos coverage with the FDA‑labeled indication and specifies the eligible AML subtypes and age groups; it also enforces the FDA‑aligned single‑dose maximums used for determining dosing appropriateness. Providers should refer to the FDA package insert for additional medication management and administration details.