Belimumab (Benlysta)

Policy ID: I-9033-005

Section: Injections

Effective Date: October 01, 2020

Revised Date: March 18, 2024

Revision Effective Date: May 01, 2024

Last Reviewed: March 19, 2024

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.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

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 (LN) AND the individual has Class III, IV, or V lupus nephritis confirmed via kidney biopsy; or
- The individual has another FDA labeled indication for belimumab (Benlysta) intravenous infusion; and
If the individual has an FDA labeled indication, then ONE of the following:
- The individual's age is within FDA labeling for the requested indication for belimumab (Benlysta) intravenous infusion; or
- There is support for using belimumab (Benlysta) intravenous infusion for the individual's age for the requested indication; and
If the individual has a diagnosis of active systemic lupus erythematosus (SLE) disease WITHOUT active Lupus Nephritis, BOTH of the following:
- 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; and
- The individual will continue standard SLE therapy (i.e., corticosteroids, hydroxychloroquine, azathioprine, methotrexate, oral cyclophosphamide, mycophenolate) in combination with belimumab (Benlysta) intravenous infusion; and
If the individual has a diagnosis of active lupus nephritis, the individual will be using belimumab (Benlysta) intravenous infusion with background immunosuppressive lupus nephritis therapy (e.g., corticosteroids with mycophenolate or IV cyclophosphamide); and
ONE of the following:
- The individual is five (5) to less than (<)18 years of age; or
- BOTH of the following:
  - The individual is 18 years of age and over; and
  - ONE of the following:
    - The individual has tried self-administered belimumab (Benlysta); or
    - The individual has a diagnosis of lupus nephritis and has NOT yet received 2 doses in the health care setting; or
    - There is support for the use of the provider-administered product over a self-administered product; 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
ONE of the following:
- The individual will NOT be using belimumab (Benlysta) intravenous infusion in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using belimumab (Benlysta) intravenous infusion in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for belimumab (Benlysta) intravenous infusion does NOT limit the use with another immunomodulatory agents; and
  - There is support for the use of combination therapy (copy of support required, e.g., clinical trials, phase III studies, guidelines).

The use of belimumab (Benlysta) intravenous infusion for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

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
The individual has had clinical benefit with belimumab (Benlysta) intravenous infusion; 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 is currently using standard SLE therapy (i.e., corticosteroids, hydroxychloroquine, azathioprine, methotrexate, oral cyclophosphamide, mycophenolate); 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 BOTH of the following:
  - The individual is currently using background immunosuppressive lupus nephritis therapy (e.g., corticosteroids with mycophenolate or IV cyclophosphamide); and
  - The individual will continue background immunosuppressive lupus nephritis therapy (e.g., corticosteroids with mycophenolate or IV cyclophosphamide); or
- The individual has another FDA approved indication for belimumab (Benlysta) intravenous infusion; and
ONE of the following:
- The individual is five (5) to less than (<)18 years of age; or
- BOTH of the following:
  - The individual is 18 years of age and over; and
  - ONE of the following:
    - The individual has tried self-administered belimumab (Benlysta); or
    - There is support for the use of the provider-administered product over a self-administered product; 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
ONE of the following:
- The individual will NOT be using belimumab (Benlysta) intravenous infusion in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using belimumab (Benlysta) intravenous infusion in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for belimumab (Benlysta) intravenous infusion does NOT limit the use with another immunomodulatory agents; and
  - There is support for the use of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).

Procedure Code

J0490

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. 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

Agents NOT to be used Concomitantly (subject to change)

Abrilada (adalimumab-afzb)
Actemra (tocilizumab)
Adalimumab
Adbry (tralokinumab-ldrm)
Amjevita (adalimumab-atto)
Arcalyst (rilonacept)
Avsola (infliximab-axxq)
Benlysta (belimumab)
Bimzelx (bimekizumab-bkzx)
Cibinqo (abrocitinib)
Cimzia (certolizumab)
Cinqair (reslizumab)
Cosentyx (secukinumab)
Cyltezo (adalimumab-adbm)
Dupixent (dupilumab)
Enbrel (etanercept)
Entyvio (vedolizumab)
Fasenra (benralizumab)
Hadlima (adalimumab-bwwd)
Hulio (adalimumab-fkjp)
Humira (adalimumab)
Hyrimoz (adalimumab-adaz)
Idacio (adalimumab-aacf)
Ilaris (canakinumab)
Ilumya (tildrakizumab-asmn)
Inflectra (infliximab-dyyb)
Infliximab
Kevzara (sarilumab)
Kineret (anakinra)
Litfulo (ritlecitinib)
Nucala (mepolizumab)
Olumiant (baricitinib)
Omvoh (mirikizumab-mrkz)
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)
Siliq (brodalumab)
Simponi (golimumab)
Simponi ARIA (golimumab)
Skyrizi (risankizumab-rzaa)
Sotyktu (deucravacitinib)
Stelara (ustekinumab)
Taltz (ixekizumab)
Tezspire (tezepelumab-ekko)
Tremfya (guselkumab)
Truxima (rituximab-abbs)
Tysabri (natalizumab)
Velsipity (etrasimod)
Wezlana (ustekinumab-auub)
Xeljanz (tofacitinib)
Xeljanz XR (tofacitinib extended release)
Xolair (omalizumab)
Yuflyma (adalimumab-aaty)
Yusimry (adalimumab-aqvh)
Zeposia (ozanimod)
Zymfentra (infliximab-dyyb)

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; and
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'; and
Added Zeposia as a contraindicated drug; and
Added list of agents contraindicated as concomitant therapy.

Internal Medical Policy Committee 3-23-2023 Effective May 01, 2023

Added another FDA labeled indication criteria; and
Updated age criteria; and
Updated the concomitantly statement; and
Removed FDA labeled contraindications criteria; and
Updated Agents NOT to be used Concomitantly list.

Internal Medical Policy Committee 3-19-2024 Effective May 01, 2024

Updated initial and reauthorization criteria wording; and
Updated Agents NOT to be used Concomitantly list.

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-9033-004

Section: Injections

Effective Date: October 01, 2020

Revised Date: March 16, 2023

Revision Effective Date: May 01, 2023

Last Reviewed: March 23, 2023

Archived Date: April 30, 2024

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 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 (LN) AND the individual has Class III, IV, or V lupus nephritis confirmed via kidney biopsy; and
If the individual has an FDA approved indication, then ONE of the following:
- The individual's age is within FDA labeling for the requested indication for belimumab (Benlysta) intravenous infusion; 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; or
- The individual has another FDA labeled indication for belimumab (Benlysta) intravenous infusion; and
ONE of the following:
- The individual is five (5) to less than 18 years of age; or
- BOTH of the following:
  - The individual is 18 years of age and over; and
  - ONE of the following:
    - The individual has tried self-administered belimumab (Benlysta); or
    - The individual has a diagnosis of lupus nephritis and has NOT yet received 2 doses in the health care setting; or
    - The prescriber has provided information to support the use of the provider-administered product over a self-administered product; 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
ONE of the following:
- The individual will NOT be using belimumab (Benlysta) intravenous infusion in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using belimumab (Benlysta) intravenous infusion in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for belimumab (Benlysta) intravenous infusion does NOT limit the use with another immunomodulatory agents; and
  - The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).

Procedure Code

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; or
- The individual has another FDA approved indication for belimumab (Benlysta) intravenous infusion AND has had clinical benefit with belimumab (Benlysta) intravenous infusion; and
ONE of the following:
- The individual is five (5) to less than 18 years of age; or
- BOTH of the following:
  - The individual is 18 years of age and over; and
  - ONE of the following:
    - The individual has tried self-administered belimumab (Benlysta); or
    - The prescriber has provided information to support the use of the provider-administered product over a self-administered product; 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
ONE of the following:
- The individual will NOT be using belimumab (Benlysta) intravenous infusion in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using belimumab (Benlysta) intravenous infusion in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for belimumab (Benlysta) intravenous infusion does NOT limit the use with another immunomodulatory agents; and
  - The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).

Procedure Code

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

Agents NOT to be used Concomitantly

Adbry (tralokinumab-ldrm)

Actemra (tocilizumab)

Arcalyst (rilonacept)

Avsola (infliximab-axxq)

Benlysta (belimumab)

Cibinqo (abrocitinib)

Cimzia (certolizumab)

Cinqair (reslizumab)

Cosentyx (secukinumab)

Dupixent (dupilumab)

Enbrel (etanercept)

Entyvio (vedolizumab)

Fasenra (benralizumab)

Humira (adalimumab)

Ilaris (canakinumab)

Ilumya (tildrakizumab-asmn)

Inflectra (infliximab-dyyb)

Infliximab

Kevzara (sarilumab)

Kineret (anakinra)

Nucala (mepolizumab)

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)

Siliq (brodalumab)

Simponi (golimumab)

Simponi ARIA (golimumab)

Skyrizi (risankizumab-rzaa)

Sotyktu (deucravacitinib)

Stelara (ustekinumab)

Taltz (ixekizumab)

Tezspire (tezepelumab-ekko)

Tremfya (guselkumab)

Truxima (rituximab-abbs)

Tysabri (natalizumab)

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Xolair (omalizumab)

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, and
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', and
Added Zeposia as a contraindicated drug, and
Added list of agents contraindicated as concomitant therapy

Internal Medical Policy Committee 3-23-2023 Effective May 01, 2023

Added another FDA labeled indication criteria
Updated age criteria
Updated the concomitantly statement
Removed FDA labeled contraindications criteria
Updated Agents NOT to be used Concomitantly list

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