Medical Policy

Effective Date:01/01/2015 Title:Beleodaq (Belinostat)
Revision Date:01/01/2016 Document:BI467:00
CPT Code(s):C9442, J9032
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Beleodaq (Belinostat) requires prior authorization.

2)    Beleodaq is used to treat a type of lymphoma.

3)    Beleodaq is considered a specialty drug and is covered under the medical benefit.

Medical Statement

Medical Policy Statement:

Beleodaq (Belinostat) is considered medically necessary for patients with the following conditions:

1) Peripheral T-celllymphoma that is relapsed or refractory, requesting second line therapy or greater for ANY ONE of the following:

·         Angioimmunoblastic T-cell lymphoma

·         Peripheral T-cell lymphoma not otherwise specified

·         Anaplastic large cell lymphoma

·         Enteropathy-associated T-cell lymphoma

·         Monomorphic epitheliotropic intestinal T-cell lymphoma

2) Adult T-cell leukemia/lymphoma if ANY ONE of the following:

·         Single agent therapy if non-responsive to first-line therapy for acute disease

·         Subsequent therapy after high dose therapy/autologous stem cell rescue (HDT/ASCR)

3) Mycosis fungoides (MF)/Sezary syndrome (SS) as single-agent therapy for Stage IB-IIA, IIB, or IV tumor with an aggressive growth rate;

4) Primary cutaneous CD30+ T-cell lymphoproliferative disorder as single agent therapy for relapsed or refractory disease of ANY ONE of the following:

·         Primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions,

·         Cutaneous anaplastic large cell lymphoma (ALCL (excluding systemic disease) with regional nodes.



Codes Used In This BI:


C9442 – Injection, Belinostat, 10mg (deleted 12/31/2015)

J9032 – Injection, Belinostat, 10mg (effective 1/1/2016)

Intentially left empty

1)    Beleodaq Package Insert.  Spectrum Pharmaceuticals.  July 2014.

2)    Clinical Pharmacology.  Accessed online November 17, 2014.

3)    NCCN Drugs & Biologic Compendium.  Accessed online March 9, 2018.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.