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Date Printed: December 18, 2017: 11:44 AM

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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-J1000-35

Original Effective Date: 08/15/11

Reviewed: 07/09/14

Revised: 12/15/17

Subject: Belimumab (Benlysta®) 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
           

DESCRIPTION:

Belimumab (Benlysta) is a human monoclonal antibody that inhibits B lymphocyte stimulator protein (BLyS). In March 2011, belimumab was approved the US Food and Drug Administration (FDA) for the treatment of active, autoantibody positive systemic lupus erythematosus (SLE). Belimumab was originally approved as an intravenous injection, but a subcutaneous formulation was was approved in 2017. Belimumab should be used as an adjunct to standard therapy. SLE is a chronic inflammatory disease of unknown cause that can affect multiple systems including the musculoskeletal, renal, pulmonary, gastrointestinal, and hematologic systems. The etiology of SLE is not completely understood; however, many of the clinical manifestations are mediated directly or indirectly by antibody formation and the creation of immune complexes.

Diagnosis of SLE is based on classification criteria developed by the American Rheumatism Association (now the American College of Rheumatology [ACR]) that uses history, physical examination, and laboratory data for diagnosis. Several disease activity instruments are used in clinical trials. The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is comprised of 24 clinical and laboratory manifestations of SLE that are scored based on presence or absence in the previous 10 days. Organ involvement is weighted and the final score can range from 0-105. A SLEDAI score of 6 or more has been shown to be consistent with active disease requiring therapy. The SLEDAI was modified in the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) trial; this modification, known as SELENA-SLEDAI added clarity to some of the definition of activity in the individual items but did not change the basic scoring system. A clinically meaningful difference has been reported to be an improvement of 7 points or a worsening of 8 points. The British Isles Lupus Assessment Group (BILAG) is an organ specific, 86 question assessment based on the healthcare provider’s intention to treat. The assessor scores organ manifestations as improve (=1), same (=2), worse (=3), or new (=4) over the last month.

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, or emergency facility is not considered medically necessary. This statement applies to Benlysta for subcutaneous administration only.

Initiation of belimumab (Benlysta®) meets the definition of medical necessity when used for treatment of active systemic lupus erythematosus (SLE) and ALL of the following criteria are met:

1. Member’s disease is active as evidenced by Safety of Estrogens in Lupus Erythematosus National Assessment modification of the SLE Disease Activity Index (SELENA-SLEDAI) score of 6 or greater while on current regimen.

2. Member is auto-antibody positive as evidenced by EITHER of the following:

a. Anti-nuclear antibody (ANA) titer greater than or equal to 1:80

b. Anti-double-stranded DNA greater than or equal to 30 IU/mL

3. Member is currently receiving standard of care SLE treatment including one or more of the following

a. Corticosteroids (e.g., prednisone)

b. Aspirin

c. Non-steroidal anti-inflammatory drug (NSAID)

d. Anti-malarials (e.g., hydroxychloroquine, chloroquine)

e. Non-biologic immunosuppressants (e.g., azathioprine, methotrexate, cyclosporine, oral cyclophosphamide)

4. There is no evidence of severe lupus nephritis within the past 90 days, defined as absence of ALL of the following

a. Proteinuria greater than 6 g/24 hours

b. Serum creatinine greater than 2.5 mg/dL

c. Hemodialysis

5. There is no evidence of active central nervous system lupus (e.g., psychosis, seizures, cerebrovascular accident) within the past 60 days

6. Belimumab is not administered concomitantly with other biologic therapies (examples listed below) or intravenous cyclophosphamide.

a. Abatacept (Orencia)

b. Adalimumab (Humira)

c. Anakinra (Kineret)

d. Certolizumab (Cimzia)

e. Etanercept (Enbrel)

f. Golimumab (Simponi)

g. Infliximab (Remicade)

h. Tocilizumab (Actemra)

i. Tofacitinib (Xeljanz)

j. Ustekinumab (Stelara)

7. Member is 18 years of age or older

8. The dose does not exceed EITHER of the following

a. IV injection:

i. First 6 weeks: 10 mg/kg every 2 weeks for 3 doses (approval duration 42 days)

ii. Thereafter: 10 mg/kg every 4 weeks (approval duration 180 days)

b. SC injection: 200 mg once weekly (approval duration 180 days)

NOTE: SELENA-SLEDAI scoring system can be located at www.rheumatology.org

Continuation of belimumab (Benlysta®) meets the definition of medical necessity when ALL of the following criteria are met:

1. Member has been approved by another healthplan or met Florida Blue’s initial criteria for coverage

2. Member has demonstrated a beneficial response with belimumab therapy for the treatment of active systemic lupus erythematosus

3. Belimumab is not administered concomitantly with another biologic therapy (examples listed below) or intravenous cyclophosphamide.

a. Abatacept (Orencia)

b. Adalimumab (Humira)

c. Anakinra (Kineret)

d. Certolizumab (Cimzia)

e. Etanercept (Enbrel)

f. Golimumab (Simponi)

g. Infliximab (Remicade)

h. Tocilizumab (Actemra)

i. Tofacitinib (Xeljanz)

j. Ustekinumab (Stelara)

4. The dose does not exceed EITHER of the following:

a. IV injection:10 mg/kg every 4 weeks

b. SC injection: 200 mg once weekly

Approval duration: 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:

• Intravenous Administration

o 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter. Reconstitute, dilute, and administer as an intravenous infusion over a period of 1 hour.

o Consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions.

• Subcutaneous Administration

o 200 mg once weekly.

Drug Availability:

• 120 mg or 400 mg lyophilized powder in single-dose vials for reconstitution and dilution prior to intravenous infusion

• 200 mg/mL single-dose prefilled autoinjector or single-dose prefilled syringe

PRECAUTIONS:

CONTRAINDICATION: belimumab is contraindicated in persons who experienced a previous anaphylactic reaction when administered belimumab.

WARNINGS/PRECAUTIONS:

Mortality: more deaths were reported with belimumab than with placebo during the controlled phase of clinical trials.

Serious infections: serious and sometimes fatal infections have been reported in persons receiving immunosuppressive agents, including belimumab. Use with caution in persons with chronic infections. Consider interrupting belimumab therapy if a member develops a new infection while on treatment.

Progressive Multifocal Leukoencephalopathy (PML): Persons with new-onset or deteriorating neurological signs and symptoms should be evaluated for PML by an appropriate specialist. If PML is confirmed, considered discontinuing immunosuppressant therapy, including belimumab.

Hypersensitivity reactions: serious and fata reactions have been reported. Belimumab should be administered by a healthcare provider prepared to manage anaphylaxis. Monitor members during and for an appropriate period of time after belimumab administration.

Depression: depression and suicidality have been reported in belimumab studies. Members should be instructed to contact their healthcare provider f they experience new or worsening depression, suicidal thoughts, or other mood changes.

Immunization: live vaccines should not be given concurrently with belimumab.

BILLING/CODING INFORMATION:

HCPCS Coding for belimumab IV infusion:

J0490

Injection, belimumab, 10 mg

HCPCS Coding for belimumab SC injection:

J3590

Unclassified biologics

ICD-10 Diagnoses Codes That Support Medical Necessity:

M32.10 – M32.9

Systemic lupus erythematosus, organ or system involvement unspecified

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) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

Systemic lupus erythematosus: is a systemic autoimmune disease than can affect any part of the body. As occurs in other autoimmune diseases, the immune system attacks the body's cells and tissue, resulting in inflammation and tissue damage.

RELATED GUIDELINES:

None

OTHER:

None

REFERENCES:

  1. Belimumab. In McEvoy GK, editor. AHFS drug information 2014 [monograph on the internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2014 [cited 2014 Jun 6]. Available from http://online.statref.com Subscription required to review.
  2. Benlysta (belimumab) [package insert]. Human Genome Sciences, Inc. Rockville (MD): July 2017.
  3. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;20174. URL www.clinicalpharmacilogy-ip.com Accessed 9/20/17.
  4. Ingenix HCPCS Level II, Expert 2013.
  5. Ingenix ICD-9-CM for Physicians-Volumes 1 & 2, Expert 2013
  6. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 9/20/17.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 10/11/17.

GUIDELINE UPDATE INFORMATION:

08/15/11

New Pharmacy Coverage Guideline.

01/01/12

Revision to guideline; consisting of updating codes.

08/15/12

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

12/15/12

Revision to guideline; consisting of modifying continuation criteria.

08/15/13

Review and revision to guideline; consisting of reformatting position statement, dosage/administration, and precautions sections; revised description section and updated references.

08/15/14

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

11/01/15

Revision: ICD-9 Codes deleted.

11/15/17

Revision to guideline to include SC formulation in position statement, dosing and administration, references

12/15/17

Revision to guideline to update coding.

Date Printed: December 18, 2017: 11:44 AM