CurrentmhnPolicy CP.PHAR.311

BELEODAQ - HNMC (PDF)

Defines medical necessity criteria, dosing limits, approved and NCCN-recommended off-label indications, continuity criteria, approval durations by line of business, required documentation, and coding implications for belinostat (Beleodaq). Applies to Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyBELEODAQ - HNMC (PDF)

Policy CodePolicy CP.PHAR.311

Change TypeAnnual reviews and revisions (2022, 2023, 2024, 2025)

Effective DateFeb 1, 2017

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

4Q 2024 annual review: per NCCN, added that Beleodaq must be prescribed as a single agent and added requirements regarding prior therapies (with bypass allowed if prescribed as palliative therapy for PTCL); removed primary cutaneous ALCL as a coverable off-label use; removed 'gamma delta' qualifier from hepatosplenic T-cell lymphoma; references reviewed and updated.

4Q 2025 annual review: added Commercial line of business; extended initial approval duration for HIM/Medicaid from 6 to 12 months; references reviewed and updated.

4Q 2022 annual review: updated NCCN-recommended off-label uses: removed mycosis fungoides, cutaneous CD30+ T-cell lymphoma, and Sézary syndrome; added breast implant ALCL (Category 2A recommendation).

4Q 2023 annual review: no significant changes; references reviewed and updated.

1FDA-approved indications

4NCCN off-label indications

1000 mg/m2/dayMax daily dose (PTCL)

Coverage Summary

Defines medical necessity criteria and prior authorization requirements for belinostat (Beleodaq) — covered with criteria. Policy establishes initial and continuation approval criteria for adult patients (≥18 years) with relapsed/refractory peripheral T‑cell lymphoma (PTCL) and select NCCN‑recommended off‑label T‑cell lymphoma indications; requires prescriber specialty (oncologist/hematologist), documentation of prior therapies or palliative intent when applicable, single‑agent use, and dosing limits. Includes line‑of‑business specific approval durations (HIM/Medicaid and Commercial). Belinostat's FDA approval is an accelerated approval for relapsed/refractory PTCL based on tumor response rate and duration of response; continued approval may depend on confirmatory trials.

Initial Therapy Criteria

Initial Approval Criteria

Provider must submit documentation supporting that member has met all approval criteria. Beleodaq is medically necessary when the following criteria are met:

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

NCCN-Recommended Off-Label Indications (Initial Approval)

Must meet all:

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

Continuation Therapy Criteria

Continuation (Renewal) Criteria - All Indications in Section I

Must meet all:

ALL of the following

Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Beleodaq for a covered indication and has received this medication for at least 30 days
Member is responding positively to therapy
If request is for a dose increase
- New dose does not exceed 1,000 mg/m2 per day on days 1-5 of a 21-day cycle≤ 1,000 mg/m2/day on days 1-5 q21d

Other Diagnoses / Non-Authorized Indications

Other diagnoses/indications

If not listed under Section I or recent label change not reflected in policy:

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow the referenced formulary/no-coverage/non-formulary policies per line of business (HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If the requested use is NOT specifically listed under section III and criterion 1 does not apply, refer to the off-label use policy per line of business (HIM.PA.154, CP.PMN.53)

Diagnoses/Indications Not Authorized

Coverage is not authorized for:

Non-FDA approved indications which are not addressed in this policy, unless sufficient documentation of efficacy and safety per off-label use policies (HIM.PA.154, CP.PMN.53) or evidence of coverage documents is provided

Applicable Codes

HCPCS - BelinostatHCPCSCovered

J9032

Injection, belinostat, 10 mg

Provider Actions and Requirements

Prior Authorization

Submit documentation for medical necessity

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Include supporting clinical records when requesting prior authorization for belinostat (Beleodaq). Affected HCPCS code: J9032 (Injection, belinostat, 10 mg).

Prior Authorization

Provider specialty requirement

Belinostat must be prescribed by, or in consultation with, an oncologist or a hematologist for covered indications.

Clinical Evidence and References

Key evidence and guidance sources cited in the policy include the Beleodaq Prescribing Information (Acrotech Biopharma; April 2025) and NCCN T‑Cell Lymphomas Version 2.2025 and NCCN Drugs & Biologics Compendium. The policy notes that the FDA accelerated approval was granted based on tumor response rate and duration of response (with improvement in survival or disease‑related symptoms not established) and that continued approval may be contingent on confirmatory trial results.

Background

Background: Belinostat (Beleodaq) is a histone deacetylase (HDAC) inhibitor indicated for adult patients with relapsed or refractory peripheral T‑cell lymphoma (PTCL). The FDA approval is under accelerated approval based on tumor response rate and duration of response; continued approval may require verification of clinical benefit in confirmatory trials.

Definitions / key terms: PTCL = Peripheral T‑cell lymphoma; NCCN = National Comprehensive Cancer Network; FDA = Food and Drug Administration.

Revision History

4Q 2022clarified

Updated NCCN-recommended off-label uses: removed mycosis fungoides, cutaneous CD30+ T-cell lymphoma, and Sézary syndrome; added breast implant-associated ALCL (Category 2A recommendation); references reviewed and updated.

4Q 2023revised

Annual review: no significant changes; references reviewed and updated.

4Q 2024revised

Per NCCN, added requirement that Beleodaq must be prescribed as a single agent and added requirements regarding prior therapies (with bypass allowed if prescribed as palliative therapy for PTCL); removed primary cutaneous ALCL as a coverable off-label use and removed 'gamma delta' qualifier from hepatosplenic T-cell lymphoma; references reviewed and updated.