Belimumab (Benlysta)

Policy ID: I-9033-01

Section: Injections

Effective Date: July 01, 2018

Revised Date: August 31, 2020

Revision Effective Date: October 01, 2020

Last Reviewed: September 21, 2020

Description

Belimumab (Benlysta®) is a human monoclonal antibody that specifically recognizes and blocks the biological activity of B-lymphocyte stimulator. Elevated levels of BLyS prolong the survival of B lymphocytes (B cells) which can contribute to the production of autoantibodies - antibodies that target the body's own tissues. Studies have shown that belimumab can reduce autoantibody levels and help control autoimmune disease activity.

Belimumab (Benlysta) is administered either intravenously or subcutaneously, in the treatment of adult individuals with active, auto-antibody positive systemic lupus erythematosus who are receiving standard therapy.

Belimumab (Benlysta) intravenous infusion may be covered under the medical benefits; please refer to pharmacy policies for coverage of Belimumab (Benlysta) self-administered subcutaneous injection.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Belimumab (Benlysta) intravenous infusion may be considered medically necessary when ALL of the following criteria are met:

Individual is 5 years of age or older; and
Diagnosis of active systemic lupus erythematosus; and
Positive anti-nuclear antibody (ANA) titer (greater than or equal to 1:80) or anti-double-stranded DNA antibody (anti-dsDNA) greater than or equal to 30 IU/ml; and
Will continue to receive concomitant standard of care for treatment of systemic lupus which includes ANY of the following (alone or in combination):
- Corticosteroids (e.g. prednisone); or
- Antimalarials (i.e. hydroxychloroquine ); or
- Immunosuppressives (e.g. azathioprine, mycophenolate mofetil, or methotrexate).

Procedure Codes

J0490

The use of belimumab (Benlysta) intravenous infusion for all other indications is considered experimental/investigational due to lack of scientific evidence, and therefore, not covered including but not limited to ANY of the following:

Individual with active central nervous system lupus; or
Individuals with severe lupus nephritis, active nephritis, or requiring hemodialysis; or
Individuals currently being treated with biologics or intravenous cyclophosphamide.

Procedure Codes

J0490

Reauthorization Criteria

Continuation of therapy with belimumab (Benlysta) intravenous infusion may be considered medically necessary when the following criteria are met:

The individual has been previously approved for belimumab (Benlysta) intravenous infusion through Blue Cross Blue Shield of North Dakota's precertification process; and
The prescriber has provided documentation that the individual has demonstrated disease stability or beneficial response to therapy; and

The use of belimumab (Benlysta) intravenous infusion for any other indications than those listed in this policy is considered experimental/investigational, and therefore, non-covered. Scientific evidence does not support the use of belimumab (Benlysta) intravenous infusion for other indications.

Procedure Codes

J0490

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

M32.0	M32.10	M32.11	M32.12	M32.13	M32.14	M32.15
M32.19	M32.8	M32.9

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-22-2020 Decrease in age from 18 to 5 years of age

Internal Medical Policy Committee 9-21-2020 Added language that self-administered Belimumab (Benlysta) injection is a pharmacy benefit. Added reauthorization criteria

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.

Section: Injections

Effective Date: February 01, 2020

Revised Date: January 27, 2020

Last Reviewed: January 22, 2020

Archived Date: September 30, 2020

Description

Belimumab (Benlysta®) is a human monoclonal antibody that specifically recognizes and blocks the biological activity of B-lymphocyte stimulator. Elevated levels of BLyS prolong the survival of B lymphocytes (B cells) which can contribute to the production of autoantibodies – antibodies that target the body’s own tissues. Studies have shown that belimumab can reduce autoantibody levels and help control autoimmune disease activity.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Belimumab (Benlysta) may be considered medically necessary when ALL of the following criteria are met:

Individual is 5 years of age or older; and
Diagnosis of active systemic lupus erythematosus; and
Positive anti-nuclear antibody (ANA) titer (greater than or equal to 1:80) or anti-double-stranded DNA antibody (anti-dsDNA) greater than or equal to 30 IU/ml; and
Will continue to receive concomitant standard of care for treatment of systemic lupus which includes ANY of the following (alone or in combination):
- Corticosteroids (e.g. prednisone); or
- Antimalarials (i.e. hydroxychloroquine ); or
- Immunosuppressives (e.g. azathioprine, mycophenolate mofetil, or methotrexate).

Procedure Codes

J0490

The use of belimumab (Benlysta) for all other indications is considered experimental/investigational due to lack of scientific evidence, and therefore, not covered including but not limited to ANY of the following:

Individual with active central nervous system lupus; or
Individuals with severe lupus nephritis, active nephritis, or requiring hemodialysis; or
Individuals currently being treated with biologics or intravenous cyclophosphamide.

Procedure Codes

J0490

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

M32.0	M32.10	M32.11	M32.12	M32.13	M32.14	M32.15
M32.19	M32.8	M32.9

Medical Policies Quick Search

Stay updated on HealthCare News