68152-0108-XX Beleodaq 500 MG SOLR (SPECTRUM PHARMACEUTICALS)
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.
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 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 subsequent 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 used as subsequent therapy in individuals who have acute disease or lymphoma which did not respond to first-line therapy
Extranodal NK/T-Cell Lymphoma, nasal type if ALL of the following:
Used as single agent for relapsed/refractory disease
Individual previously received asparaginase based combination chemotherapy
Hepatosplenic Gamma-Delta T-Cell Lymphoma if ALL of the following:
Subsequent therapy as single agent
Refractory after 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) with generalized cutaneous or extra-cutaneous lesions
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
Belinostat is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
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.
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|All indications||1,000mg/m² daily on days 1-5 of a 21 day cycle|
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.
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.
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).
Lexi-Comp Online. (2019, February). AHFS DI. Belinostat. Retrieved March 11, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluation. (2018, November) Belinostat. Retrieved March 11, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Belinostat. Retrieved March 11, 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 March 11, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206256s002lbl.pdf.
ORIGINAL EFFECTIVE DATE: 7/23/2014
MOST RECENT REVIEW DATE: 7/31/2019
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.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 10 mg