CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Beleodaq (belinostat) — Coverage and Authorization

Defines indications, continuation and exclusion criteria, coding, and utilization management authority for belinostat (Beleodaq) for members managed by the payer's UM program.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBeleodaq (belinostat) — Coverage and Authorization

Policy CodePolicy N/A

Change TypeAdministrative update — no material clinical changes

Effective DateJan 31, 2025

Next Review DateN/A

Key ActionSubmit prior authorization to the UM department; continuation requests may be exempt if member has not progressed, use was within the last year without >30-day lapse, and no new medications are added.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9032HCPCS code listed for belinostat

1,000 mg/m2Single dose maximum listed

Relapsed/Refractory PTCLSupported single-agent indications

UM DeptUM review authority

Coverage Criteria for belinostat (Beleodaq)

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Initial or single-agent therapy coverage

Covered when ALL of the following are met

Indication: Member has relapsed or refractory T-cell lymphoma (including peripheral T-cell lymphoma, hepatosplenic gamma-delta T-cell lymphoma, extranodal NK/T-cell lymphoma nasal type) for single-agent belinostat use.

Supported by policy-supported uses.

Supportive evidence: Use is supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per CMS policy standards.

Policy references required sources.

Continuation therapy

Continuation therapy exemption when ALL of the following are met

No progression: Member has not experienced disease progression on the requested medication.

Continuation exemption criterion 1.

Recent use: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.

Continuation exemption criterion 2.

No new drugs: No additional medications are being added to the continuation request.

Continuation exemption criterion 3.

Coverage excludes concurrent administration of belinostat with other chemotherapy agents. Use is not approvable when proposed as investigational or off-label without sufficient supporting evidence as defined by the policy (for example, absence of representation of the patient population, inadequate regimen representation, lack of clinically meaningful outcomes, weak study design, reliance on case reports or abstracts). Dosing that exceeds a single dose of 1,000 mg/m2 is also excluded.

The policy specifies that belinostat is not approvable when the member experienced disease progression while receiving belinostat or has prior progression on another HDAC inhibitor (for example, romidepsin). Requests in these situations should be denied per the exclusion criteria.

Initial Therapy Criteria

Initial therapy criteria

Initial coverage when consistent with labeling and guidelines

Diagnosis: Member has relapsed/refractory T-cell lymphoma appropriate for single-agent belinostat.

Supportive evidence: Requested use aligns with FDA labeling, NCCN/ASCO, CMS compendia, or acceptable peer-reviewed literature.

Continuation and Reauthorization Criteria

Continuation exemption

Continuation requests may be exempt from re-review if ALL criteria are met

No progression: Member has not experienced disease progression on the requested medication.

Recent use without gap: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.

No added medications: Additional medication(s) are not being added to the continuation request.

Coding and Quantity Limits

Covered HCPCS CodesHCPCSCovered

J9032

Injection, belinostat, 10 mg

inv-06: Single dose limit — ≤ 1,000 mg/m2

Single dose limit≤ 1,000 mg/m2

Applies toBeleodaq (belinostat) dosing per policy

Consequence of exceedanceDosing that exceeds this limit is an exclusion and may be denied

inv-15: belinostat — single dose ≤ 1,000 mg/m2 (quantity limit)

Drug and codebelinostat (Beleodaq) — HCPCS J9032 (Injection, belinostat, 10 mg)

Quantity limit (single dose)≤ 1,000 mg/m2

Unit of measuremg/m2 per single dose

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required and processed by the Utilization Management (UM) department. Continuation (re-authorization) requests may be exempt from prior authorization only if ALL of the following are met: the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request.

Prior authorization handled by UM department
Continuation exemption requires: no progression; used within last year; ≤30-day lapse; no new agents added

Denial Risk

Triggers for Denial

Denial risk exists when any of the following apply: the member experienced disease progression while taking belinostat or on prior HDAC inhibitor therapy (e.g., romidepsin); the requested use involves concurrent administration with other chemotherapy; dosing exceeds the single-dose limit of 1,000 mg/m2; or the requested use is investigational/off-label without sufficient supporting evidence per policy.

Disease progression on belinostat or prior HDAC inhibitor (e.g., romidepsin) — denial risk
Concurrent use with other chemotherapy — denial risk
Dose > 1,000 mg/m2 single dose — denial risk
Investigational or off-label use lacking sufficient CMS-recognized compendia or acceptable peer-reviewed evidence — denial risk

Documentation Required

Supportive Documentation Required

Supportive documentation must accompany the request. Acceptable sources include FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS standards (see policy for criteria on adequate evidence such as representative patient populations, clinically meaningful outcomes, and appropriate study design).

Required documentation: FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature
Peer-reviewed evidence must meet CMS standards (e.g., representative clinical characteristics, meaningful outcomes, appropriate study design)

Step Therapy

Step Therapy Notes

Step therapy notes: there is no formal multi-step medication sequence detailed in this policy. The policy excludes concurrent use with other chemotherapy and excludes use after progression on HDAC inhibitors; these clinical constraints should be considered when assessing prior therapy and sequencing.

No formal step-therapy sequence specified in this policy
Exclusions that affect sequencing: prior progression on HDAC inhibitors and prohibition on concurrent chemotherapy

Definitions and Policy-Supported Uses

inv-12: Details of policy-supported use

Supported indicationsAs a single agent for relapsed/refractory hepatosplenic gamma-delta T-cell lymphoma

Supported indicationsAs a single agent for relapsed/refractory peripheral T-cell lymphomas

Supported indicationsAs a single agent for relapsed/refractory extranodal NK/T-cell lymphoma, nasal type

Background

Belinostat (Beleodaq) is a histone deacetylase (HDAC) inhibitor. The policy supports single-agent use for relapsed/refractory T‑cell lymphomas but requires that use align with accepted evidence sources; exclusions include progression on belinostat or prior HDAC inhibitors, concurrent chemotherapy, dosing above 1,000 mg/m2, or investigational/off-label use lacking sufficient evidence.

Quantity Limits

inv-15: belinostat — Single dose ≤ 1,000 mg/m2