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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.

09-J1000-71

Original Effective Date: 07/15/12

Reviewed: 06/11/14

Revised: 11/01/15

Subject: Plerixafor (Mozobil) 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.

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

DESCRIPTION:

Plerixafor (Mozobil®) was approved by the U.S. Food and Drug Administration (FDA) in December 2008 for use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSC) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma. Prior to FDA approval, plerixafor received orphan drug status for this same indication. Plerixafor competitively inhibits the binding of stromal-derived factor-1 (SDF-1 or CXCL12) to its receptor, CXC receptor-4 (CXCR4), allowing HSCs to mobilize into the peripheral blood, ultimately increasing the yield of HSCs for collection.

The safety and efficacy of plerixafor in combination with G-CSF were evaluated in two double-blind, placebo-controlled studies of individuals undergoing autologous HSC transplantation and diagnosed with multiple myeloma (Study 1, n=302) and non-Hodgkin’s lymphoma (Study 2, n=298). Subjects were randomized to receive G-CSF 10 mcg/kg subcutaneously every morning for up to eight days with either plerixafor 0.24 mg/kg or placebo subcutaneous every evening for up to four days beginning on day four of G-CSF treatment.

In subjects with multiple myeloma (Study 1), the primary efficacy endpoint of collecting 6,000,000 CD34+ cells/kg or greater in two or fewer days of apheresis was achieved in 72% of subjects in the plerixafor/G-CSF arm compared with 34% of subjects in the G-CSF monotherapy arm (p<0.001). In the subjects who received plerixafor/G-CSF, the median number of apheresis days necessary to collect 6,000,000 CD34+ cells/kg or greater was one day compared to four days in the patients who were mobilized with G-CSF monotherapy (p<0.001). The most common adverse events considered to be related to plerixafor were gastrointestinal disorders and injection site reactions.

In subjects with non-Hodgkin’s lymphoma (Study 2), the primary efficacy endpoint of collecting 5,000,000 CD34+ cells/kg in four or fewer days of apheresis was achieved in 59% of subjects in the plerixafor/G-CSF arm compared with 20% of subjects in the G-CSF monotherapy arm (p<0.001). The median number of days to reach the primary endpoint was not evaluated in the study. The most common adverse events considered to be related to plerixafor were gastrointestinal disorders and injection site reactions.

POSITION STATEMENT:

Plerixafor (Mozobil) injection meets the definition of medical necessity for members meeting ALL of the following criteria:

1. Diagnosis of non-Hodgkin's lymphoma or multiple myeloma

2. Approved autologous stem cell transplantation

3. Use is in combination with a granulocyte colony stimulating factor (G-CSF)

4. Dose does not exceed 0.24 mg/kg/day or 40 mg/day

5. Age 18 years or older

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

• 0.24 mg/kg (actual body weight) daily by subcutaneous injection; do not exceed 40 mg/day

• Administer dose approximately 11 hours prior to initiation of each apheresis for up to four consecutive days

• Recommended concomitant medications: Administer daily morning doses of granulocyte colony stimulating factor (10 micrograms/kg) for four days prior to the first evening dose of plerixafor and on each day prior to apheresis

Dose Adjustments

Renal Impairment

• CrCl ≤ 50 mL/min: 0.16 mg/kg once daily (maximum dose: 27 mg/day)

Drug Availability

• 24 mg single use vial (1.2 mL of 20 mg/mL solution)

PRECAUTIONS:

Precautions/Warnings

• Tumor cell mobilization

• Leukocytosis

• Thrombocytopenia

• Splenic enlargement

• Pregnancy category D

BILLING/CODING INFORMATION:

HCPCS Coding

J2562

Injection, plerixafor, 1 mg

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

C82.90 – C82.99

Follicular lymphoma, unspecified

C83.00 – C83.99

Non-follicular lymphoma

C84.00 – C84.09

Non-follicular lymphoma

C84.10 – C84.19

Sézary disease

C84.40 – C84.49

Peripheral T-cell lymphoma, not classified

C84.60 – C84.69

Anaplastic large cell lymphoma, ALK-positive

C84.70 – C84.79

Anaplastic large cell lymphoma, ALK-negative

C85.80 – C85.89

Other specified types of non-Hodgkin lymphoma

C88.8

Other malignant immunoproliferative diseases

C90.00 – C90.32

Multiple myeloma and malignant plasma cell neoplasms

C91.40 – C91.41

Hairy cell leukemia

C96.0 – C96.9

Other and unspecified malignant neoplasms of lymphoid, hematopoietic and related tissue

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 Products: No National Coverage Determination (NCD) was found at the time of the last guideline revised date. The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Plerixafor (Mozobil), (L33708) located at fcso.com.

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

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Granulocyte Colony Stimulating Factors, 09-J0000-62

OTHER:

None

REFERENCES:

  1. Genzyme Corporation. MOZOBIL (plerixafor) solution. 2010 [cited 2014 Apr 25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a56b1b78-0ae2-41b4-9c76-98ad9d439199/.
  2. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2014 [cited 2014 Apr 25]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  3. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2014 [cited 2014 Apr 25]. Available from: http://www.clinicalpharmacology.com/.
  4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2014 Apr 25]. Available from: http://www.thomsonhc.com/.
  5. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2014 [cited 2014 Apr 25]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  6. DiPersio JF, Micallef IN, Stiff PJ, et al. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol. 2009;27(28):4767-73.
  7. DiPersio JF, Stadtmauer EA, Nademanee A, et al. Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. Blood. 2009:113(23):5720-6.
  8. Ingenix HCPCS Level II, Expert 2012.
  9. Ingenix ICD-9-CM for Physicians-Volumes 1 & 2, Expert 2012.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 06/11/14.

GUIDELINE UPDATE INFORMATION:

07/15/12

New Medical Coverage Guideline.

07/15/13

Review and revision to guidelines; consisting of description, position statement, decision tree and program exceptions

07/15/14

Review and revision to guideline; consisting of description, position statement, references, and decision tree.

10/01/15

Revision consisting of update to Program Exceptions section.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: December 16, 2017: 09:15 PM