BlueCross BlueShield of Tennessee Medical Policy Manual

Belinostat

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

  • 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.

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

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

• Belinostat is considered medically appropriate if for the diagnosis of Non-Hodgkin lymphoma further diagnosed as ANY ONE of the following:

• • Individual is 18 years of age or older

  • Used as single agent systemic therapy

  • Diagnosis of ANY ONE of the following:

  • • Peripheral T-cell lymphoma (PTCL) that is relapsed or refractory prior to treatment for second–line or greater therapy, including ANY ONE of the following conditions:

    • • 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

      • Follicular T-cell lymphoma

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

    • • Second-line therapy prior to high dose therapy/autologous stem cell rescue (HDT/ASCR) if non-responsive to first-line therapy for acute disease

      • Used as subsequent therapy to HDT/ASCR if non-responsive to first-line therapy for acute disease

    • Extranodal NK/T-Cell Lymphoma, nasal type if ALL of the following:

    • • Used as single agent for relapsed/refractory disease

      • Treatment following additional therapy with alternate combination chemotherapy regimen not previously used (asparaginase-based)

    • Hepatosplenic Gamma-Delta T-Cell Lymphoma if ALL of the following:

    • • Second-line and subsequent therapy as single agent

      • Must have received two primary treatment regimens

    • Mycosis fungoides (MF)/Sézary syndrome (SS) for ANY ONE of the following:

    • • Systemic therapy as primary treatment for ANY ONE of the following:

      • • Stage IV non-Sézary or visceral disease (solid organ)

        • Large cell transformation (LCT)

      • Systemic therapy for ANY ONE of the following:

      • • Relapsed, refractory or persistent MF disease

        • Relapsed or persistent stage IV Sézary syndrome

        • Large cell transformation (LCT) that is relapsed, persistent or refractory to multiple therapies

    • Primary cutaneous CD30+ T-cell lymphoproliferative disorder for relapsed or refractory disease of ANY ONE of the following:

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

      • Cutaneous Anaplastic LargeCell Lymphoma (ALCL) (excluding systemic disease) with regional nodes

RENEWAL CRITERIA

• Belinostat is considered medically appropriate for renewal if ALL of the following criteria are met:

• • Individual continues to meet initial approval criteria

  • Tumor response with stabilization of disease or decrease in size of tumor or tumor spread

  • Absence of unacceptable toxicity from the agent, including hematologic toxicity (thrombocytopenia, neutropenia and/or, anemia), severe infections, hepatotoxicity, tumor lysis syndrome, severe gastrointestinal toxicity, etc.

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed

Refer to DOSAGE LIMITS below

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

Lexi-Comp Online. (2019). AHFS DI. Belinostat. Retrieved January 15, 2019 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluation. (2018, November) Belinostat. Retrieved January 15, 2019 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium^®. Belinostat. Retrieved January 15, 2019 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2017, April). Center for Drug Evaluation and Research. Beleodaq^® (belinostat) for injection, for intravenous administration. Retrieved January 15, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206256s002lbl.pdf.

ORIGINAL EFFECTIVE DATE: 7/23/2014

MOST RECENT REVIEW DATE:  5/31/2019

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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.

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