Anifrolumab-fnia (Saphnelo)

Policy ID: I-9242-005

Section: Injections

Effective Date: October 01, 2021

Revised Date: March 18, 2024

Revision Effective Date: May 01, 2024

Last Reviewed: March 19, 2024

Applies To: Commercial and Medicaid Expansion

Description

Anifrolumab-fnia (Saphnelo) is a human monoclonal antibody that specifically recognizes and blocks the biological activity of type I interferons (IFN).

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.

Anifrolumab-fnia (Saphnelo) may be considered medically necessary when ALL of the following criteria are met:

ONE of the following:
- Information has been provided that indicates the individual has been treated with anifrolumab-fnia (Saphnelo) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with anifrolumab-fnia (Saphnelo) (starting on samples is not approvable) 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 moderate to severe SLE; 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 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 another FDA labeled indication for anifrolumab-fnia (Saphnelo); and
If the individual has an FDA labeled indication, then ONE of the following:
- The individual's age is within FDA labeling for anifrolumab-fnia (Saphnelo); or
- There is support for using anifrolumab-fnia (Saphnelo) 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, then BOTH of the following:
- The individual is currently treated with 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) in combination with anifrolumab-fnia (Saphnelo); and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., rheumatologist) 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 does NOT have severe active lupus nephritis; and
ONE of the following:
- The individual will NOT be using anifrolumab-fnia (Saphnelo) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using anifrolumab-fnia (Saphnelo) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for anifrolumab-fnia (Saphnelo) 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 anifrolumab-fnia (Saphnelo) 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

J0491

Reauthorization Criteria

Continuation of therapy with anifrolumab-fnia (Saphnelo) may be considered medically necessary when the following criteria are met:

The individual has been previously approved for anifrolumab-fnia (Saphnelo) through the Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has had clinical benefit with anifrolumab-fnia (Saphnelo); and
ONE of the following
- The individual has a diagnosis of active systemic lupus erythematosus (SLE) disease WITHOUT active Lupus Nephritis AND ALL 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 another FDA labeled indication for anifrolumab-fnia (Saphnelo); and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., rheumatologist) 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 does NOT have severe active lupus nephritis; and
ONE of the following:
- The individual will NOT be using anifrolumab-fnia (Saphnelo) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using anifrolumab-fnia (Saphnelo) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for anifrolumab-fnia (Saphnelo) 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

J0491

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

M32.15

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 9-21-2021- Effective October 01, 2021

Adopted new precertification policy

Internal Medical Policy Committee 11-23-2021 - Effective January 01, 2022

Added new code C9086

Internal Medical Policy Committee 3-23-2022 - Effective April 01, 2022

Added new procedure code J0491 to policy; and
Removed procedure code C9086

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

Added another FDA labeled indication 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-9242-004

Section: Injections

Effective Date: October 01, 2021

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

Anifrolumab-fnia (Saphnelo) is a human monoclonal antibody that specifically recognizes and blocks the biological activity of type I interferons (IFN).

Criteria

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

Anifrolumab-fnia (Saphnelo) may be considered medically necessary when ALL of the following criteria are met:

ONE of the following:
- Information has been provided that indicates the individual has been treated with anifrolumab-fnia (Saphnelo) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with anifrolumab-fnia (Saphnelo) (starting on samples is not approvable) 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 moderate to severe SLE; 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); and
If the individual has an FDA approved indication, then ONE of the following:
- The individual's age is within FDA labeling for anifrolumab-fnia (Saphnelo); or
- The prescriber has provided information in support of using anifrolumab-fnia (Saphnelo) 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 BOTH of the following:
  - The individual is currently treated with 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) in combination with anifrolumab-fnia (Saphnelo); or
- The individual has another FDA labeled indication for anifrolumab-fnia (Saphnelo); and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., rheumatologist) 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 does NOT have severe active lupus nephritis; and
ONE of the following:
- The individual will NOT be using anifrolumab-fnia (Saphnelo) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using anifrolumab-fnia (Saphnelo) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for anifrolumab-fnia (Saphnelo) 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

J0491

Reauthorization Criteria

Continuation of therapy with anifrolumab-fnia (Saphnelo) may be considered medically necessary when the following criteria are met:

The individual has been previously approved for anifrolumab-fnia (Saphnelo) 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 ALL 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 anifrolumab-fnia (Saphnelo); or
- The individual has another FDA approved indication for anifrolumab-fnia (Saphnelo) AND has had clinical benefit with anifrolumab-fnia (Saphnelo); and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., rheumatologist) 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 does NOT have severe active lupus nephritis; and
ONE of the following:
- The individual will NOT be using anifrolumab-fnia (Saphnelo) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using anifrolumab-fnia (Saphnelo) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for anifrolumab-fnia (Saphnelo) 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

J0491

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

M32.15

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 9-21-2021- Effective October 01, 2021

Adopted new precertification policy

Internal Medical Policy Committee 11-23-2021 - Effective January o1, 2022

Added new code C9086

Internal Medical Policy Committee 3-23-2022 - Effective April 01, 2022

Added new procedure code J0491 to policy, and
Removed procedure code C9086

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

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

Medical Policies Quick Search

Anifrolumab-fnia (Saphnelo)

Description

Policy Application

Criteria

Procedure Code

Reauthorization Criteria

Procedure Code

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Procedure Code

Reauthorization Criteria

Procedure Code

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer