BlueCross BlueShield of Tennessee Medical Policy Manual

Belinostat (Beleodaq®)

DESCRIPTION

Belinostat is a histone deacetylase (HDAC) inhibitor.  HDACs cause the removal of acetyl groups from the lysine residues of histones and other proteins.  By inhibiting this enzymatic action, belinostat causes the accumulation of acetylated histones and other proteins within the cells, inducing cell cycle arrest and/or apoptosis of some transformed cells.  It is noted that belinostat shows a preferential cytotoxicity towards tumor cells as compared to normal cells.

POLICY

• Belinostat for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

• Adult T-cell leukemia/lymphoma

• Breast Implant-Associated Anaplastic Large Cell Lymphoma (ALCL)

• Extranodal NK/T-Cell Lymphoma, nasal type

• Hepatosplenic Gamma-Delta T-Cell Lymphoma

• Mycosis fungoides (MF)/Sézary syndrome (SS)

• Peripheral T-cell lymphoma

• Primary cutaneous CD30+ T-cell lymphoproliferative disorders

• Belinostat for the treatment of other conditions/diseases is considered investigational.

MEDICAL APPROPRIATENESS

INITIAL APPROVAL CRITERIA

• Patient is at least 18 years of age; AND

Universal Criteria

• Used as a single agent; AND

T-Cell Lymphomas

• Peripheral T-Cell Lymphoma (PTCL)

(Including: 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; Nodal peripheral T-cell lymphoma with TFH phenotype; or Follicular T-cell lymphoma)

• Used as subsequent therapy for relapsed or refractory disease; OR

• Used as initial palliative intent therapy in transplant ineligible patients

• Adult T-Cell Leukemia/Lymphoma

• Used as subsequent therapy for non-responders to first-line therapy for acute lymphoma subtypes

• Extranodal NK/T-Cell Lymphoma (Nasal type)

• Patient has relapsed or refractory disease; AND

• Patient has previously received at least 2 different prior lines of therapy including an asparaginase-based combination chemotherapy regimen

• Hepatosplenic Gamma-Delta T-Cell Lymphoma

• Used as subsequent therapy for refractory disease after first-line therapy regimens

• Breast Implant-Associated Anaplastic Large Cell Lymphoma (ALCL)

• Used as subsequent therapy for relapsed or refractory disease

Primary Cutaneous Lymphomas

• Mycosis Fungoides (MF)/Sezary Syndrome

• Patient has relapsed, persistent, or refractory disease; OR

• Used as primary treatment for Stage IV non Sezary or visceral disease (solid organ): OR

• Used as primary treatment for large cell transformation (LCT) with generalized cutaneous or extra-cutaneous lesions

• Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders

• Patient has relapsed or refractory disease; AND

• • Patient has primary cutaneous anaplastic large cell lymphoma (pcALCL) with multifocal lesions; OR

  • Patient has cutaneous ALCL with regional nodes (excludes systemic ALCL)

RENEWAL CRITERIA

• Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in Initial Approval Criteria; AND

• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND

• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: hematologic toxicity (e.g., thrombocytopenia, leukopenia, and/or anemia), severe infections, hepatotoxicity, tumor lysis syndrome, severe gastrointestinal toxicity, etc.

DOSAGE/ADMINISTRATION

LENGTH OF AUTHORIZATION

Coverage will be provided for 6 months and may be renewed.

DOSING LIMITS

Max Units (per dose and over time) [HCPCS Unit]:

• All indications: 1,250 billable units every 21 days

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES

1.     Beleodaq [package insert]. Acrotech Biopharma, East Windsor, NJ; January 2020. Accessed January 2021.

2.     Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for belinostat. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2021.

3.     O'Connor OA, Masszi T, Savage KJ, et al. Belinostat, a novel pan-histone deacetylase inhibitor (HDACi), in relapsed or refractory peripheral T-cell lymphoma (R/R PTCL): Results from the BELIEF trial. Journal of Clinical Oncology 2013 31:15_suppl, 8507-8507.

4.     Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Peripheral T-Cell Lymphomas 1.20201. National Comprehensive Cancer Network, 20201. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed January 2021.

5.     Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Primary Cutaneous Lymphomas 1.2021. National Comprehensive Cancer Network, 2021. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed February 2021.

6.     Lexi-Comp Online. (2021, February). AHFS DI. Belinostat. Retrieved March 12, 2021 from Lexi-Comp Online with AHFS.

ORIGINAL EFFECTIVE DATE:  7/23/2014

MOST RECENT REVIEW DATE:    7/31/2021

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information