Belimumab (Benlysta)

Policy ID: I-9033-003

Section: Injections

Effective Date: October 01, 2020

Revised Date: March 15, 2022

Revision Effective Date: May 01, 2022

Last Reviewed: March 23, 2022

Applies To: Commercial and Medicaid Expansion

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) 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:

ONE of the following:
- Information has been provided indicating that the individual has been treated with belimumab (Benlysta) intravenous infusion within the past 90 days; or
- The prescriber states that the individual has been treated with belimumab (Benlysta) intravenous infusion within the past 90 days AND is at risk if therapy is changed; or
- The individual has a diagnosis of active systemic lupus erythematosus (SLE) disease WITHOUT active Lupus Nephritis BOTH of the following:
  - ONE of the following:
    - The individual has tried and had an inadequate response to hydroxychloroquine; or
    - The individual has an intolerance or hypersensitivity to hydroxychloroquine; or
    - The individual has an FDA labeled contraindication to hydroxychloroquine; and
  - ONE of the following:
    - The individual has tried and had an inadequate response to corticosteroids OR immunosuppressives (i.e., azathioprine, methotrexate, oral cyclophosphamide, mycophenolate); or
    - The individual has an intolerance or hypersensitivity to therapy with corticosteroids OR immunosuppressives (i.e., azathioprine, methotrexate, oral cyclophosphamide, mycophenolate); or
    - The individual has an FDA labeled contraindication to ALL corticosteroids AND immunosuppressives (i.e., azathioprine, methotrexate, oral cyclophosphamide, mycophenolate); or
- The individual has a diagnosis of active lupus nephritis AND the individual has Class III, IV, or V lupus nephritis confirmed via kidney biopsy; and
ONE of the following:
- The individual’s is five (5) years of age or older with active SLE; or
- The individual is eighteen (18) years of age or older with active lupus nephritis; or
- The prescriber has provided information in support of using belimumab (Benlysta) intravenous infusion for the individual’s age; and
ONE of the following:

- The individual has a diagnosis of active systemic lupus erythematosus (SLE) disease WITHOUT active Lupus Nephritis AND the individual is currently treated with and will continue standard SLE therapy (i.e., corticosteroids, hydroxychloroquine, azathioprine, methotrexate, oral cyclophosphamide, mycophenolate) in combination with belimumab (Benlysta) intravenous infusion; or
- The individual has a diagnosis of active lupus nephritis AND the individual is currently treated with and will continue standard lupus nephritis therapy (i.e., azathioprine, mycophenolate, IV cyclophosphamide) in combination with belimumab (Benlysta) intravenous infusion; and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist, nephrologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
The individual does NOT have severe active central nervous system lupus; and
The individual will NOT be using belimumab (Benlysta) intravenous infusion in combination with another biologic agent or Zeposia; and
The individual does NOT have any FDA labeled contraindications to belimumab (Benlysta) intravenous infusion.

Belimumab (Benlysta) intravenous infusion for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.

Procedure Codes

J0490

Reauthorization Criteria

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

The individual has been previously approved for belimumab (Benlysta) intravenous infusion through the Blue Cross Blue Shield of North Dakota’s precertification process; and
ONE of the following:
- The individual has a diagnosis of active systemic lupus erythematosus (SLE) disease WITHOUT active Lupus Nephritis AND BOTH of the following:
  - The individual will continue standard SLE therapy (i.e., corticosteroids, hydroxychloroquine, azathioprine, methotrexate, oral cyclophosphamide, mycophenolate); and
  - The individual has had clinical benefit with belimumab (Benlysta) intravenous infusion; or
- The individual has a diagnosis of active lupus nephritis AND BOTH of the following:
  - The individual will continue standard lupus nephritis therapy (i.e., azathioprine, mycophenolate, IV cyclophosphamide); and
  - The individual has had clinical benefit with belimumab (Benlysta) intravenous infusion; and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist, nephrologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
The individual does NOT have severe active central nervous system lupus; and
The individual will NOT be using belimumab (Benlysta) intravenous infusion in combination with another biologic agent or Zeposia; and
The individual does NOT have any FDA labeled contraindications to belimumab (Benlysta) intravenous infusion.

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

FDA Labeled Contraindication(s)

Individuals with previous anaphylaxis to belimumab

Biologic Agents not allowed as Concomitant Therapy

Actemra (tocilizumab)

Arcalyst (rilonacept)

Avsola (infliximab-axxq)

Benlysta (belimumab)

Cimzia (certolizumab)

Cosentyx (secukinumab)

Enbrel (etanercept)

Entyvio (vedolizumab)

Humira (adalimumab)

Ilaris (canakinumab)

Ilumya (tildrakizumab-asmn)

Inflectra (infliximab-dyyb)

Infliximab

Kevzara (sarilumab)

Kineret (anakinra)

Olumiant (baricitinib)

Opzelura (ruxolitinib)

Orencia (abatacept)

Otezla (apremilast)

Remicade (infliximab)

Renflexis (infliximab-abda)

Riabni (rituximab-arrx)

Rinvoq (upadacitinib)

Rituxan (rituximab)

Rituxan Hycela (rituximab/hyaluronidase human)

Ruxience (rituximab-pvvr)

Saphnelo (anifrolumab-fnia)

Siliq (brodalumab)

Simponi (golimumab)

Simponi ARIA (golimumab)

Skyrizi (risankizumab-rzaa)

Stelara (ustekinumab)

Taltz (ixekizumab)

Tremfya (guselkumab)

Truxima (rituximab-abbs)

Tysabri (natalizumab)

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Zeposia (ozanimod)

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

Internal Medical Policy Committee 3-17-2021 Added active lupus nephritis indication and updated SLE criteria

Internal Medical Policy Committee 3-23-2022 Added “is currently treated with” standard therapy in addition to continue standard therapy “in combination with belimumab (Benlysta) intravenous infusion”, added Zeposia as a contraindicated drug, added list of agents contraindicated as concomitant therapy

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.

Policy ID: I-9033-002

Section: Injections

Effective Date: October 01, 2020

Revised Date: March 08, 2021

Revision Effective Date: May 01, 2021

Last Reviewed: March 17, 2021

Archived Date: April 30, 2022

Applies To: Commercial and Medicaid Expansion

Description

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.

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

ONE of the following:
- Information has been provided indicating that the individual has been treated with belimumab (Benlysta) intravenous infusion within the past 90 days; or
- The prescriber states that the individual has been treated with belimumab (Benlysta) intravenous infusion within the past 90 days AND is at risk if therapy is changed; or
- The individual has a diagnosis of active systemic lupus erythematosus (SLE) disease WITHOUT active Lupus Nephritis AND ALL of the following:
  - The individual has a history of positive antinuclear antibody (ANA) results; and
  - The individual has a SLE additive diagnostic criteria score ≥10; and
  - BOTH of the following:
    - ONE of the following:
      - The individual has tried and had an inadequate response to hydroxychloroquine; or
      - The individual has an intolerance or hypersensitivity to hydroxychloroquine; or
      - The individual has an FDA labeled contraindication to hydroxychloroquine; and
    - ONE of the following:
      - The individual has tried and had an inadequate response to corticosteroids OR immunosuppressives (i.e., azathioprine, methotrexate, oral cyclophosphamide, mycophenolate); or
      - The individual has an intolerance or hypersensitivity to therapy with corticosteroids OR immunosuppressives (i.e., azathioprine, methotrexate, oral cyclophosphamide, mycophenolate); or
      - The individual has an FDA labeled contraindication to ALL corticosteroids AND immunosuppressives (i.e., azathioprine, methotrexate, oral cyclophosphamide, mycophenolate); or
- The individual has a diagnosis of active lupus nephritis AND ALL of the following:
  - The individual has a clinical diagnosis of SLE confirmed by BOTH of the following:
    - The individual has a history of positive antinuclear antibody (ANA) results; and
    - The individual has a SLE additive diagnostic criteria score ≥10; and
  - The individual has Class III, IV, or V lupus nephritis confirmed via kidney biopsy; and
ONE of the following:
- The individual’s is five (5) years of age or older with active SLE; or
- The individual is eighteen (18) years of age or older with active lupus nephritis; or
- The prescriber has provided information in support of using belimumab (Benlysta) intravenous infusion for the individual’s age; and
ONE of the following:
- The individual has a diagnosis of active systemic lupus erythematosus (SLE) disease WITHOUT active Lupus Nephritis AND the individual will continue standard SLE therapy (i.e., corticosteroids, hydroxychloroquine, azathioprine, methotrexate, oral cyclophosphamide, mycophenolate); or
- The individual has a diagnosis of active lupus nephritis AND the individual will continue standard lupus nephritis therapy (i.e., azathioprine, mycophenolate, IV cyclophosphamide); and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist, nephrologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
The individual does NOT have severe active central nervous system lupus; and
The individual will NOT be using belimumab (Benlysta) intravenous infusion in combination with another biologic agent; and
The individual does NOT have any FDA labeled contraindications to belimumab (Benlysta) intravenous infusion.

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 the Blue Cross Blue Shield of North Dakota’s precertification process; and
ONE of the following:
- The individual has a diagnosis of active systemic lupus erythematosus (SLE) disease WITHOUT active Lupus Nephritis AND BOTH of the following:
  - The individual will continue standard SLE therapy (i.e., corticosteroids, hydroxychloroquine, azathioprine, methotrexate, oral cyclophosphamide, mycophenolate); and
  - The individual has had clinical benefit with belimumab (Benlysta) intravenous infusion; or
- The individual has a diagnosis of active lupus nephritis AND BOTH of the following:
  - The individual will continue standard lupus nephritis therapy (i.e., azathioprine, mycophenolate); and
  - The individual has had clinical benefit with belimumab (Benlysta) intravenous infusion; and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist, nephrologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
The individual does NOT have severe active central nervous system lupus; and
The individual will NOT be using belimumab (Benlysta) intravenous infusion in combination with another biologic agent; and
The individual does NOT have any FDA labeled contraindications to belimumab (Benlysta) intravenous infusion.

Procedure Codes

J0490

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

FDA Labeled Contraindication(s)

Individuals with previous anaphylaxis to belimumab

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

Internal Medical Policy Committee 3-17-2021 Added active lupus nephritis indication and updated SLE 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.

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