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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-J2000-27

Original Effective Date: 03/15/15

Reviewed: 10/12/16

Revised: 01/01/17

Subject: Alemtuzumab (Lemtrada™) IV

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  
           

DESCRIPTION:

Alemtuzumab (Lemtrada) was approved by the U.S. Food and Drug Administration (FDA) in November 2014 for the treatment of relapsing forms of multiple sclerosis. Due to the potential for serious adverse effects, it should be reserved for patients who have had an inadequate response to at least 2 drugs for the treatment of multiple sclerosis.

In two randomized trials, the rate of multiple sclerosis (MS) relapse was significantly reduced with alemtuzumab (rate of relapse, 22% and 35%) compared with interferon beta-1a (rate of relapse, 40% and 53%) in untreated (CARE-MS I; N=581) and previously treated (CARE-MS II; N=840) patients with relapsing-remitting MS. Alemtuzumab significantly improved the sustained accumulation of disability over 6 months compared with interferon beta-1a among previously treated patients (12.71% vs 21.13%); however, significance was not reached among previously untreated patients. In both studies alemtuzumab was associated with a higher incidence of serious infections, immune thrombocytopenia, autoimmunity, and thyroid papillary carcinoma, as well as a significantly higher incidence of herpes viral infections despite prophylaxis with acyclovir.

The FDA has required a Risk Evaluation and Mitigation Strategy for alemtuzumab.

POSITION STATEMENT:

NOTE: Aubagio, Avonex, Betaseron, Copaxone, Gilenya, Glatopa, Plegridy, Rebif and Tecfidera are preferred products for treatment of relapsing forms of multiple sclerosis.

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

1. Member is diagnosed with a relapsing form of multiple sclerosis (i.e., relapsing remitting multiple sclerosis [RRMS], secondary progressive MS [SPMS], progressive-relapsing MS [PRMS]).

2. Member has tried and failed treatment with at least two of the following agents:

a. Dimethyl fumarate (Tecfidera)

b. Fingolimod (Gilenya)

c. Glatiramer acetate (Copaxone, Glatopa)

d. Interferon beta-1a (Avonex, Rebif)

e. Interferon beta-1b (Betaseron, Extavia)

f. Mitoxantrone (Novantrone)

g. Natalizumab (Tysabri)

h. Peg-interferon beta-1a (Plegridy)

i. Teriflunomide (Aubagio)

3. Member has not previously been treated with alemtuzumab

4. Alemtuzumab is not administered in combination with ANY of the following:

a. Daclizumab (Zinbryta)

b. Dimethyl fumarate (Tecfidera)

c. Fingolimod (Gilenya)

d. Glatiramer acetate (Copaxone, Glatopa)

e. Interferon beta-1a (Avonex, Rebif)

f. Interferon beta-1b (Betaseron, Extavia)

g. Mitoxantrone (Novantrone)

h. Natalizumab (Tysabri)

i. Peg-interferon beta-1a (Plegridy)

j. Teriflunomide (Aubagio)

5. Dose does not exceed 12 mg/day

Duration of approval: 5 doses

Continuation of alemtuzumab (Lemtrada) meets the definition of medical necessity when ALL of the following criteria are met:

1. Member has demonstrated a beneficial response associated with alemtuzumab

2. Use is NOT in combination with any of the following:

a. Daclizumab (Zinbryta)

b. Dimethyl fumarate (Tecfidera)

c. Fingolimod (Gilenya)

d. Glatiramer acetate (Copaxone, Glatopa)

e. Interferon beta-1a (Avonex, Rebif)

f. Interferon beta-1b (Betaseron, Extavia)

g. Mitoxantrone (Novantrone)

h. Natalizumab (Tysabri)

i. Peg-interferon beta-1a (Plegridy)

j. Teriflunomide (Aubagio)

3. Member has not utilized any of the following agents since initiating treatment with alemtuzumab:

a. Daclizumab (Zinbryta)

b. Dimethyl fumarate (Tecfidera)

c. Fingolimod (Gilenya)

d. Glatiramer acetate (Copaxone, Glatopa)

e. Interferon beta-1a (Avonex, Rebif)

f. Interferon beta-1b (Betaseron, Extavia)

g. Mitoxantrone (Novantrone)

h. Natalizumab (Tysabri)

i. Peg-interferon beta-1a (Plegridy)

j. Teriflunomide (Aubagio)

4. Member has received fewer than two treatment courses of alemtuzumab

5. Member has not received alemtuzumab in the previous 12 months

6. Dose does not exceed 12 mg/day

Duration of approval: 3 doses

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

• Administer by intravenous infusion over 4 hours for 2 treatment courses:

o First course: 12 mg/day on 5 consecutive days

o Second course: 12 mg/day on 3 consecutive days 12 months after first treatment course

• Premedicate with corticosteroids prior to infusion for the first 3 days of each treatment course

• Administer antiviral agents for herpetic prophylaxis starting on the first day of dosing and continuing for a minimum of two months after completion of dosing or until CD4+ lymphocyte count is more than 200 cells per microliter, whichever occurs later

Dilute prior to administration

Dose Adjustments

Refer to prescribing information.

Drug Availability

• Injection: 12 mg/1.2 mL (10 mg/mL) in a single-use vial

PRECAUTIONS:

Boxed Warning

• Causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease

• Causes serious and life-threatening infusion reactions

• May cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders

• Available only through a restricted distribution program

Contraindications

• Infection with Human Immunodeficiency Virus

Precautions/Warnings

• Thyroid Disorders: obtain thyroid function tests prior to initiation of treatment and every 3 months until 48 months after the last infusion.

• Monitor complete blood counts monthly until 48 months after the last infusion

• Consider delaying initiation in patients with active infections until the infection is fully controlled

• Do not administer live viral vaccines following a course of treatment

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J0202

Injection, alemtuzumab, 1 mg

Do NOT use code J9010 (injection, alemtuzumab, 10 mg). This is a retired code for Campath.

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

G35

Multiple sclerosis

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:

Relapsing-remitting multiple sclerosis (RRMS): Characterized by acute attacks followed by periods of remission; primary form of MS that occurs in approximately 85% of patients.

Primary-progressive multiple sclerosis (PPMS): Steadily progressive course from onset with no acute attacks; occurs in 10-15% of patients with MS.

Secondary-progressive multiple sclerosis (SPMS): An initial period of RRMS, followed by a steadily progressive course, with or without acute relapses; 75-85% of patients diagnosed with RRMS will transition to SPMS.

Progressive-relapsing multiple sclerosis (PRMS): Steadily progressive course from onset with acute attacks, with or without recovery; occurs in less than 5% of MS patients.

RELATED GUIDELINES:

Botulinum Toxins, 09-J0000-29
Diagnosis and Treatment of Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis, 02-35000-01

Dimethyl Fumarate (Tecfidera), 09-J1000-96

Fingolimod (Gilenya™), 09-J1000-30

Functional Neuromuscular Stimulation, 09-E0000-54

Immune Globulin Therapy, 09-J0000-06

Magnetic Resonance Imaging (MRI) Brain and Head, 04-70540-11

Multiple Sclerosis Self Injectable Therapy, 09-J1000-39

Natalizumab (Tysabri®) IV, 09-J0000-73

Teriflunomide (Aubagio), 09-J1000-82

OTHER:

None

REFERENCES:

  1. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2016 [cited 2016-09-24].
  2. Bayer. Betaseron (interferon beta-1b) injection. 2014 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66311f74-0472-4fa3-848a-06002ca0def5/.
  3. Biogen. Avonex (interferon beta-1a) injection. 2008 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=84d42ba4-6eef-41a7-a1d1-2cc887ef118d/.
  4. Biogen. Plegridy (peginterferon beta-1a) injection. 2014 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08f0ea03-4e6d-195d-aef4-886e32befa95/.
  5. Biogen. Tecfidera (dimethyl fumarate) capsule. 2015 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=665d7e74-036c-5f68-5b67-ab84b9b49151/.
  6. Biogen. Tysabri (natalizumab) injection. 2015 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5fdde91-1989-4dd2-9129-4f3323ea2962/.
  7. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2016 [cited 2016-09-22]. Available from: http://www.clinicalpharmacology.com/.
  8. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2015-08-25]. Available from: http://clinicaltrials.gov/.
  9. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2016-09-22]. Available from: http://www.thomsonhc.com/.
  10. EMD Serono. Rebif (interferon beta-1a) injection. 2015 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f/.
  11. Freedman MS. Treatment options for patients with multiple sclerosis who have suboptimal response to interferon-β therapy. Eur J Neurol 2014;21:377-87.
  12. Genzyme. Aubagio (teriflunomide) tablet, film coated. 2014 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4650d12c-b9c8-4525-b07f-a2d773eca155/.
  13. Genzyme. Lemtrada (alemtuzumab injection) solution, concentrate. 2016 [cited 2016-09-26]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6236b0bc-82e9-4447-9a78-f57d94770269/.
  14. Limmroth V. Treatment of relapsing-remitting multiple sclerosis: current and future algorithms. Eur J Neurol 2014;72:35-8.
  15. Mikol DD, Barkhof F, Chang P, et al. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs. Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicenter, randomized, parallel, open-label trial. Lancet Neurol 2008;7:903-14.
  16. Multiple Sclerosis Coalition. The use of disease-modifying therapies in multiple sclerosis: principles and current evidence. Available at http://www.nationalmssociety.org/getmedia/5ca284d3-fc7c-4ba5-b005-ab537d495c3c/DMT_Consensus_MS_Coalition_color. Accessed 09/26/2016.
  17. National Clinical Advisory Board of the National Multiple Sclerosis Society. Disease management consensus statement. Available at http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/treatments/index.aspx Accessed 08/13/2012.
  18. Novartis. Extavia (interferon beta-1b) injection. 2014 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4cfdb571-ec4c-478f-bedc-e0669eeea504/.
  19. Novartis. Gilenya (fingolimod hydrochloride) capsule. 2015 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cc9e1c8c-0e2b-44e2-878b-27057f786be9/.
  20. Oliver BJ, Kohli E, Kasper LH. Interferon therapy in relapsing-remitting multiple sclerosis: A systematic review and meta-analysis of the comparative trials. J Neurol Sci 2011;302:96-105.
  21. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2016 [cited 2016-09-22]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  22. Sandoz. Glatopa (glatiramer acetate) injection. 2015 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5f01e40a-b6f6-40fb-b37c-3d06f1428e86/.
  23. Teva. Copaxone (glatiramer acetate) injection. 2014 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aa88f583-4f5f-433b-80b4-1f4c9fb28357/.
  24. Wiendl H, Toyka KV, Rieckmann R, et.al. Basic and escalating immunomodulatory treatments in multiple sclerosis: current therapeutic recommendations. J Neurol 2008;255:1449-63.
  25. Wingerchuk DM, Carter JL. Multiple sclerosis: current and emerging disease-modifying therapies and treatment strategies. Mayo Clin Proc 2014;89:225-40.

COMMITTEE APPROVAL:

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

GUIDELINE UPDATE INFORMATION:

03/15/15

New Medical Coverage Guideline.

10/01/15

Revision to guideline consisting of HCPCS code update.

10/15/15

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

01/01/16

Annual HCPCS coding update: added code J0202 and deleted codes C9399 and C9979.

01/01/17

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

Date Printed: June 28, 2017: 11:57 PM