HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
I-245-001
Topic:
Anifrolumab-fnia (Saphnelo)
Section:
Injections
Effective Date:
March 6, 2022
Issued Date:
March 6, 2022
Last Revision Date:
December 2021
Annual Review:
December 2021
 
 

Anifrolumab-fnia (SaphneloTM) is a type I interferon (IFN) receptor antagonist indicated for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

Policy Position

Anifrolumab-fnia (Saphnelo) may be considered medically necessary for individuals 18 years of age or older when ALL the following criteria are met:

  • Individual is diagnosed with moderate to severe SLE; and
  • Individual does not have severe active lupus nephritis or severe active central nervous system lupus; and
  • Documentation by prescriber includes EITHER of the following:

o   Positive anti-nuclear antibody (ANA) titer greater than or equal to 1:80; or

o   Anti double strand DNA antibody (anti-dsDNA) greater than or equal to 30 IU/mL; and

  • Individual meets ONE of the following:

o   The individual is receiving at least one (1) concomitant standard therapy for the treatment of SLE which include:

§  Corticosteroids (e.g., prednisone); or

 

§  Antimalarials (e.g., hydroxychloroquine); or

§  Immunosuppressives (e.g., azathioprine, mycophenolate mofetil, methotrexate); or

 

o   Individual has experienced therapeutic failure or intolerance of two (2) standard therapies or all classes are contraindicated; and

  • Individual is not receiving any other biologic agent; and
  • Initial authorization will be for a 12 month period.

Reauthorization Criteria

  • Continuation of anifrolumab-fnia (Saphnelo) for the treatment of SLE may be considered medically necessary when the initial criteria are met and the individual has documented positive clinical response (e.g. reduction in disease severity per reduction in flares, reduced organ dysfunction, reduction in corticosteroid dose); and
  • Continuation of at least one (1) concomitant standard of care for the treatment of SLE; and
  • Reauthorization will be for a 12 month period.

The use of Anifrolumab-fnia (Saphnelo) for any other indication will be considered experimental/investigational as the published peer reviewed literature does not support its efficacy or safety for any other indications.

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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. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits. 



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Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Anifrolumab-fnia (Saphnelo) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of insured business and, if elected, ASO.



Links





This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.




Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.