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Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2015, 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 2015 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.

09-J1000-54

Original Effective Date: 01/01/12

Reviewed: 11/12/14

Revised: 12/15/14

Subject: Vorinostat (Zolinza®) Capsules

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.

Position Statement

Dosage/ Administration

Billing/Coding

Reimbursement

Program Exceptions

Definitions

Related Guidelines

Other

References

Updates

Previous Information

DESCRIPTION:

Cutaneous T-cell lymphomas (CTCL) represent a heterogeneous group of non-Hodgkin lymphomas characterized by an initial inflammation of the skin with clonally-derived malignant T lymphocytes. The diversity of clinical and pathologic manifestations among subsets of CTCL has led to much controversy over its diagnosis and classification and to the establishments of consensus guidelines by a joint effort of the World Health Organization and European Organization for Research and Treatment of Cancer (WHO-EORTC) in 2005.

The two most common types of CTCL are mycosis fungoides (MF), which is generally indolent in behavior, and Sézary syndrome (SS), an aggressive leukemic form of the disease. Together, MF and SS comprise 54% of all CTCL. Current treatment options include skin-directed therapies, with the addition of systemic therapy for refractory, persistent, or progressive disease.

Vorinostat (Zolinza®) was approved by the FDA in 2006 for the treatment of relapsed/refractory CTCL. It exerts it activity through inhibition of histone deacetylase (HDAC) and ultimately causes cell cycle arrest and apoptosis.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

Vorinostat meets the definition of medical necessity for members diagnosed with EITHER of the following conditions when ALL associated criteria are met:

1. Cutaneous T-Cell Lymphoma (e.g., Mycosis Fungoides, Sézary Syndrome)

a. Disease is progressive, persistent, or recurrent

b. Member has tried and failed, not tolerated, or has a contraindication to two systemic therapies (e.g., bexarotene, photopheresis)

c. Member is 18 years of age or older

d. Dose does not exceed 400 mg (four capsules) daily

2. Multiple Myeloma

a. Disease is relapsed or refractory

b. Member is receiving vorinostat as salvage therapy in combination with bortezomib

c. Member has received two or more anti-myeloma regimens

d. Member is 18 years of age or older

e. Dose does not exceed 400 mg (four capsules) daily

Duration of approval: 1 year

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:

• 400 mg orally once daily with food

Dosage Adjustments:

• Intolerance: 300 mg orally once daily with food; if necessary, the dose can be further reduced to 300 mg once daily with food for five consecutive days each week

Drug Availability: Vorinostat is available as a 100 mg hard gelatin capsule.

PRECAUTIONS:

Boxed Warning

None

Contraindications

None

Precautions/Warnings

Thromboembolism: Pulmonary embolism and deep vein thrombosis have been reported; members should be monitored for signs and symptoms.

Hematologic: Dose-related thrombocytopenia and anemia have occurred and may require dosage adjustment or discontinuation. Complete blood counts, including platelets, should be monitored every 2 weeks during the first 2 months and monthly thereafter, or as clinically indicated. Concomitant administration with other agents known to cause thrombocytopenia should be done with caution.

Gastrointestinal: Gastrointestinal disturbances, including nausea, vomiting and diarrhea, have been reported and may require the use of antiemetic, antidiarrheal medications, and fluid and electrolytes should be replaced to prevent dehydration.

Hyperglycemia: Serum glucose should be monitored, especially in diabetic or potentially diabetic patients. Adjustment of diet and/or therapy for increased glucose may be necessary.

Monitoring: The manufacturer recommends a complete blood count and basic metabolic panel (including electrolytes, glucose, and serum creatinine) every 2 weeks during the first 2 months of therapy and monthly thereafter

Pregnancy: Vorinostat is classified as Pregnancy Category D; although there are no adequate and well-controlled studies of vorinostat in pregnant women, results of animal studies indicate that it crosses the placenta and is found in fetal plasma.

Lactation: It is not known whether vorinostat is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from vorinostat, it should be avoided in women who are breastfeeding.

BILLING/CODING INFORMATION:

HCPCS Coding

J8999

Prescription drug, oral, chemotherapeutic, NOS

ICD-9 Diagnoses Codes That Support Medical Necessity

202.10 – 202.18

Mycosis fungoides

202.20 – 202.28

Sézary disease

203.00

Multiple Myeloma

203.02

Multiple Myeloma, in relapse

203.10

Plasma cell leukemia, without mention of having achieved remission

203.12

Plasma cell leukemia in relapse

203.80

Other immunoproliferative neoplasms, without mention of having achieved remission

203.82

Other immunoproliferative neoplasms, in relapse

238.6

Neoplasm of uncertain behavior of plasma cells

V10.79

Personal history of other lymphatic and hematopoietic neoplasms

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

C84.00 – C84.09

Mycosis fungoides

C84.10 – C84.19

Sézary disease

C90.02

Multiple Myeloma in relapse

C90.10

Plasma cell leukemia not having achieved remission

C90.12

Plasma cell leukemia in relapse

C88.8

Other malignant immunoproliferative diseases

C90.20

Extramedullary plasmacytoma not having achieved remission

C90.22

Extramedullary plasmacytoma in relapse

C90.30

Solitary plasmacytoma not having achieved remission

C90.32

Solitary plasmacytoma in relapse

D47.Z9

Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue

Z85.79

Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

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

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Bexarotene (Targretin®) Capsules 09-J0000-41

Bortezomib (Velcade®) IV 09-J0000-92

OTHER:

None

REFERENCES:

  1. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2014 [cited 2014 Oct 2]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  2. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2014 [cited 20014 Oct 2]. Available from: http://www.clinicalpharmacology.com/.
  3. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 20143 Oct 2]. Available from: http://clinicaltrials.gov/.
  4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2014 Oct 2]. Available from: http://www.thomsonhc.com/.
  5. Merck Sharp & Dohme Corp. Zolinza (vorinostat) capsule. 2006 [cited 2014 Oct 2]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cd86ee78-2781-468b-930c-3c4677bcc092/.
  6. Multiple myeloma treatment guidelines [Internet]. Version 1.2014. Fort Washington (PA): National Comprehensive Cancer Network; 2014 [cited 2014 Oct 2]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp/.
  7. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2014 [cited 2014 Oct 2]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  8. Non-Hodgkin’s lymphoma treatment guidelines [Internet]. Version 2.2013. Fort Washington (PA): National Comprehensive Cancer Network; 2014 [cited 2014 Oct 2]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp/.
  9. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2014 [cited 2014 Oct 2]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 11/12/14.

GUIDELINE UPDATE INFORMATION:

01/01/12

New Medical Coverage Guideline.

12/15/12

Review and revision to guideline; consisting of revising, reformatting, and updating position statement, dosage and administration section; reformatting precautions/warning section; updating references and related guidelines; adding contraindications section, updating coding.

12/15/13

Review and revision to guideline; consisting of position statement, dose/administration, precautions/warnings, program exceptions, references

12/15/14

Review and revision to guideline; consisting of references.

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is copyright 2013, 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 2013 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.

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Date Printed: July 5, 2015: 10:48 PM