Print

Date Printed: October 20, 2017: 08:41 AM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

9-J2000-21

Original Effective Date: 11/15/14

Reviewed: 10/12/16

Revised: 11/15/16

Subject: Belinostat (Beleodaq™) Injection

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  

Previous Version

           

DESCRIPTION:

Belinostat (Belodaq®) was approved by the U.S. Food and Drug Administration (FDA) in July 2014 for treatment of relapsed or refractory peripheral T-cell lymphoma. This indication was approved under accelerated approval based on tumor response rate and duration of response; an improvement in survival or disease‐related symptoms has not been established. Prior to FDA approval, belinostat received orphan drug status for treatment of relapsed or refractory peripheral T-cell lymphoma. Belinostat inhibits the histone deacetylase family of enzymes to stimulate the immune system and block angiogenesis.

National Comprehensive Cancer Network (NCCN) Guidelines for Non-Hodgkin’s Lymphomas (Version 3.2016) include recommendations for use of belinostat.

POSITION STATEMENT:

Initiation of belinostat (Beleodaq) meets the definition of medical necessity when ALL of the following criteria are met:

1. Use is for treatment of an indication listed in Table 1 and ALL of the indication-specific criteria are met

2. The dose does not exceed 1000 mg/m2 on days 1-5 of a 21-day cycle

Table 1

Indication for Use

Criteria

Adult T-Cell leukemia/lymphoma (ATLL)

Use is a medical necessity when ALL criteria are met:

1. Member did not respond to first-line therapy for acute disease or lymphoma (NOT to be used for chronic/smoldering ATLL)

Mycosis Fungoides (MF)/Sezary Syndrome (SS)

Use is a medical necessity when ALL criteria are met:

1. Member’s disease meets ANY of the following:

a. Stage IB to IIA disease with histologic evidence of folliculotropic or large cell transformation

b. Stage IIB with generalized extent tumor, transformed, and/or folliculotropic disease with or without skin-directed therapy

c. Stage IV non-Sezary or visceral disease

2. Belinostat is used as single-agent therapy

Peripheral T-cell Lymphoma

Use is a medical necessity when ALL criteria are met:

1. Member’s disease is relapsed or refactory

2. Belinostat is used as second-line or subsequent therapy for ANY of the following disease types:

a. Angioimmunoblastic T-cell lymphoma

b. Peripheral T-cell lymphoma not otherwise specified (NOS)

c. Anaplastic large cell lymphoma (ALCL)

d. Enteropathy-associated T-cell lymphoma

Primary cutaneous CD30+ T-Cell lymphoproliferative disorders

Use is a medical necessity when ALL criteria are met:

1. Member’s disease is relapsed or refactory

2. Member’s disease meets EITHER of the following:

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

b. Cutaneous ALCL with regional nodes (excludes systemic ALCL)

3. Belinostat is used as a single-agent therapy

Duration of approval: 6 months

Continuation of belinostat (Beleodaq) meets the definition of medical necessity for members meeting the following criteria:

1. Authorization/reauthorization for belinostat (Beleodaq) has been previously approved by Florida Blue or another health plan in the past two years for the treatment of an indication in Table 1 OR the member currently meets all indication-specific initiation criteria

2. Member has not experienced disease progression while receiving treatment with belinostat

3. The dose does not exceed 1000 mg/m2 on days 1-5 of a 21-day cycle

Duration of approval: 6 months

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

• 1,000 mg/m2 administered over 30 minutes by intravenous infusion once daily on days 1-5 of a 21-day cycle

• Cycles can be repeated until disease progression or unacceptable toxicity

Dose Adjustments

• Adjust dose due to treatment-related toxicity

Drug Availability

• 500 mg, lyophilized powder in single-use vial for reconstitution

PRECAUTIONS:

Boxed Warning

None

Contraindications

None

Precautions/Warnings

• Thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia

• Infection: Serious and fatal infections (e.g., pneumonia and sepsis)

• Hepatotoxicity

• Tumor lysis syndrome

• Embryo-fetal toxicity

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J9032

Injection, belinostat, 10 mg

ICD-10 Diagnoses Codes That Support Medical Necessity (Effective 10/01/15)

C84.00C84.09

Mycosis fungoides

C84.40

Peripheral T-cell lymphoma, not classified unspecified site

C84.41

Peripheral T-cell lymphoma, not classified lymph nodes of head, face, and neck

C84.42

Peripheral T-cell lymphoma, not classified intrathoracic lymph nodes

C84.43

Peripheral T-cell lymphoma, not classified intra-abdominal lymph nodes

C84.44

Peripheral T-cell lymphoma, not classified lymph nodes of axilla and upper limb

C84.45

Peripheral T-cell lymphoma, not classified lymph nodes of inguinal region and lower limb

C84.46

Peripheral T-cell lymphoma, not classified intrapelvic lymph nodes

C84.47

Peripheral T-cell lymphoma, not classified spleen

C84.48

Peripheral T-cell lymphoma, not classified lymph nodes of multiple sites

C84.49

Peripheral T-cell lymphoma, not classified extranodal and solid organ sites

C84.60-C84.69

Anaplastic large cell lymphoma, ALK-positive

C84.70-C84.79

Anaplastic large cell lymphoma, ALK-negative

C86.2

Enteropathy-type (intestinal) T-cell lymphoma

C86.5

Angioimmunoblastic T-cell lymphoma

C86.6

Primary cutaneous CD30-positive T-cell proliferations

C91.50

Adult T-cell lymphoma/leukemia (HTLV-1-associated) not having achieved remission

C91.51

Adult T-cell lymphoma/leukemia (HTLV-1-associated) in remission

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

None

RELATED GUIDELINES:

None

OTHER:

None

REFERENCES:

  1. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2015 [cited 2015 Sep 3]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  2. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2016 [cited 2016 Sep 3]. Available from: http://www.clinicalpharmacology.com/.
  3. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2016 Sep 3]. Available from: http://clinicaltrials.gov/.
  4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2016 Sep 3]. Available from: http://www.thomsonhc.com/.
  5. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Non-Hodgkin’s Lymphomas, v. 3.2016 [cited 2016 Sep 8]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  6. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2016 [cited 2016 Sep 25]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  7. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2016 [cited 2016 Sep 3]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  8. Spectrum. Beleodaq (belinostat) injection. 2014 [cited 2016 Sep 3]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=84b2e16e-f0d1-4757-8da8-79dfa83aab79/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 10/12/16.

GUIDELINE UPDATE INFORMATION:

11/15/14

New Medical Coverage Guideline.

11/01/15

Revision: ICD-9 Codes deleted.

11/15/15

Review and revision to guideline; consisting of updating position statement and references

01/01/16

Annual HCPCS coding update: added code J9032 and deleted codes C9442 and J9999.

11/15/16

Review and revision to guideline; consisting of updating position statement, coding, references

Date Printed: October 20, 2017: 08:41 AM