mhn belinostat (Beleodaq) Coverage Update

Coverage Criteria for Belinostat (Beleodaq)

inv-01: Initial Approval — Peripheral T‑Cell Lymphoma

Covered when ALL of the following are met for Initial Approval — Peripheral T‑Cell Lymphoma:

PTCL initial approval criteria

Diagnosis of peripheral T‑cell lymphoma (see Appendix D for subtypes).
Prescribed by or in consultation with an oncologist or hematologist.
Member is age ≥ 18 years.
Prior therapy or palliative use
- Prescribed as initial palliative intent therapy.
- Failure of at least one prior therapy (see Appendix B for examples).
Prescribed as a single agent.
Dosing limits or evidence support
- Dose does not exceed 1,000 mg/m2 per day on days 1-5 of a 21‑day cycle.1,000 mg/m2 days 1-5
- Dose is supported by practice guidelines or peer‑reviewed literature for the relevant use (prescriber must submit supporting evidence).

Approval duration

HIM/Medicaid: 12 months.
Commercial: 6 months or to the member's renewal date, whichever is longer.

inv-02: NCCN‑Recommended Off‑Label Indications

Covered when ALL of the following are met for NCCN‑recommended off‑label indications:

NCCN off-label criteria

Diagnosis of one of the following: (a) adult T‑cell leukemia/lymphoma after failure of first‑line therapy; (b) extranodal NK/T‑cell lymphoma, nasal type following asparaginase‑based therapy; (c) hepatosplenic T‑cell lymphoma after failure of 2 prior treatment regimens; (d) breast implant‑associated anaplastic large cell lymphoma after failure of first‑line therapy.
Prescribed by or in consultation with an oncologist or hematologist.
Member is age ≥ 18 years.
Prescribed as a single agent.
Dosing limits or evidence support

inv-03: Continuation Therapy

Covered when ALL of the following are met for Continuation/Renewal:

Continuation criteria

Member is currently receiving belinostat via the Centene benefit, or documentation supports that the member has received belinostat for at least 30 days.
Member is responding positively to therapy (clinical documentation required).
Dose increase conditions
- Requested new dose does not exceed 1,000 mg/m2 per day on days 1-5 of a 21‑day cycle.1,000 mg/m2 days 1-5
- Requested new dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

inv-04: Dosing and prior therapy requirements for PTCL

Covered when ALL of the following are met

PTCL dosing: Belinostat dosed at 1,000 mg/m2 IV on days 1-5 of a 21-day cycle; cycles may be repeated every 21 days until disease progression or unacceptable toxicity.1,000 mg/m2 days 1-5

Maximum 1,000 mg/m2/day

Prior therapy: Policy requires prior therapies per NCCN-aligned updates; a bypass is allowed if prescribed as palliative therapy for PTCL.prior therapy required unless palliative bypass

See policy for specific prior therapy examples (Appendix B).

Requests for use of belinostat for non‑FDA approved indications that are not specifically addressed within this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with the plan’s off‑label use policies (for example, HIM.PA.154 for Marketplace or CP.PMN.53 for Medicaid) and any applicable evidence of coverage documents. Providers should submit relevant clinical records (e.g., office notes, pathology, imaging, and peer‑reviewed literature or guideline citations) to support medical necessity for off‑label requests.

Per the 4Q2024 NCCN‑aligned updates applied to this policy, primary cutaneous anaplastic large cell lymphoma (ALCL) has been removed as a coverable off‑label use for belinostat because it is no longer recommended by NCCN.

The 4Q2022 NCCN updates removed several previously recommended off‑label indications for belinostat. Specifically, coverage for mycosis fungoides, cutaneous CD30+ T‑cell lymphoma, and Sézary syndrome was removed from the recommended off‑label list and is no longer supported by this policy.

Initial Therapy—Dosing and Prescriber Requirements

inv-24: Initial Therapy — PTCL

Initial approval dosing and prescriber requirements.

Prescriber and age

Prescribed by or in consultation with an oncologist or hematologist.
Member is age ≥ 18 years.

Agent and regimen

Prescribed as a single agent (Beleodaq).
Prescribed regimen must be FDA‑approved or recommended by NCCN.

Dosing

Continuation / Renewal Authorization

inv-26: Continuation Therapy Authorization

Continuation/renewal authorization rules and durations.

Continuation authorization criteria

Member has received belinostat for at least 30 days via Centene or documentation supports current use.
Member is responding to therapy (clinical documentation required).
If a dose increase is requested, the new dose must not exceed 1,000 mg/m2 per day on days 1-5 of a 21‑day cycle, or the prescriber must submit supporting evidence that the higher dose is recommended by practice guidelines or peer‑reviewed literature.

Authorization duration

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization & Coding

Prior Authorization Required: Beleodaq (belinostat) requests may require prior authorization. Prior therapies may themselves require authorization; for PTCL indications, belinostat must be prescribed as a single agent and approval requires verification of prior therapy history unless prescribed as initial palliative intent therapy.

HCPCS code: J9032 (Injection, belinostat, 10 mg) — include on claim per coding guidance; providers should confirm current coding guidance prior to claim submission.
Prior authorization may be required for prior therapies referenced in Appendix B.

Documentation Required

Required Documentation

Documentation Required: Provider must submit documentation (e.g., office chart notes, relevant laboratory results, pathology reports, treatment history) to demonstrate the member meets all approval criteria. For off‑label or nonstandard doses, the prescriber must include supporting evidence (practice guidelines or peer‑reviewed literature) when dose/regimen differs from FDA-approved labeling.

Coding, Dosing, and Schedule

Covered HCPCS CodesHCPCS

J9032

Injection, belinostat, 10 mg

Maximum daily dose — inv-09

Maximum daily dose1,000 mg/m2 per day on days 1-5 of a 21-day cycle

Cycle length21-day cycle (days 1-5 dosing)

Repeat untilCycles may be repeated every 21 days until disease progression or unacceptable toxicity

Dosing schedule — inv-10

Dosing scheduleDays 1-5 of a 21-day cycle

Administration routeIntravenous (IV)

Cycle repetition

Step Therapy / Therapeutic Alternatives

Therapeutic alternative	Regimen / notes
Brentuximab vedotin + CHP
CHOP
CHOEP
Dose-adjusted EPOCH
DHAP
ESHAP
HyperCVAD (alternating with high-dose methotrexate and cytarabine)
AspaMetDex (for extranodal NK/T‑cell lymphoma — asparaginase‑based)
DDGP (for extranodal NK/T‑cell lymphoma — asparaginase‑based)
Modified‑SMILE (for extranodal NK/T‑cell lymphoma — asparaginase‑based)

Requirement	Policy detail
Prior therapy requirement
Per 4Q2024 NCCN-aligned update, belinostat (Beleodaq) must be prescribed as a single agent and requirements regarding prior therapies were added; a bypass is allowed if prescribed as palliative therapy for PTCL.

Quantity Limits and Product Details

Belinostat (Beleodaq) — inv-30

Recommended daily dose1,000 mg/m2 per day (IV)

Dosing daysDays 1-5 of a 21-day cycle

Maximum per-dayMaximum listed as 1,000 mg/m2/day

Beleodaq (belinostat) — inv-31

Single-dose vial size500 mg

PackagingSingle-dose vial

Site of care noteProduct supplied as single‑dose 500 mg vial; administer in appropriate infusion setting

Site of Care & Administration

Note

Product supplied as 500 mg single‑dose vial; site of care not restricted

Belinostat is supplied as single‑dose 500 mg vials; the policy does not restrict site of care, but the drug is administered intravenously in an appropriate infusion setting.

Product availability: single‑dose vial 500 mg.
Administration: belinostat 1,000 mg/m2 IV on days 1–5 of a 21‑day cycle, delivered in an infusion setting.

Note

Intravenous administration in appropriate infusion setting

Administer belinostat intravenously per the dosing schedule (1,000 mg/m2 IV on days 1–5 of a 21‑day cycle) in an appropriate infusion center or setting.

Dosing schedule and administration are IV on days 1–5 of a 21‑day cycle.
Provide treatment in an infusion setting able to manage therapy per dosing and monitoring requirements.

Background

Belinostat is a histone deacetylase (HDAC) inhibitor with an FDA indication for treatment of adult patients with relapsed or refractory peripheral T‑cell lymphoma (PTCL). The accelerated approval was based on response rates, and continued approval depends on verification of clinical benefit; dosing for the PTCL indication is 1,000 mg/m2 IV on days 1–5 of a 21‑day cycle.

Definitions

PTCL (peripheral T‑cell lymphoma) — inv-21

DefinitionPeripheral T‑cell lymphoma (PTCL): a heterogeneous group of non‑Hodgkin T‑cell lymphomas

Appendix D examplesPTCL not otherwise specified; Anaplastic large cell lymphoma; Angioimmunoblastic T‑cell lymphoma; Enteropathy‑associated T‑cell lymphoma; Monomorphic epitheliotropic intestinal T‑cell lymphoma; Nodal PTCL with TFH phenotype; Follicular T‑cell lymphoma

Classification noteList provided as general guidance; refer to WHO classification for complete list

PTCL dosing regimen — inv-22

PTCL dosing regimenBelinostat 1,000 mg/m2 IV on days 1-5 of a 21-day cycle

Treatment durationCycles may be repeated every 21 days until disease progression or unacceptable toxicity

OpenPayer

Belinostat (Beleodaq) — Coverage Criteria