Anifrolumab-fnia (Saphnelo) (Medicaid Expansion)

Policy ID: ME-I-245-005-01

Section: Injections

Effective Date: December 09, 2024

Last Reviewed: November 19, 2024

Applies To: Medicaid Expansion Only

Description

Anifrolumab-fnia (Saphnelo ^TM ) 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 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

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:
- Positive anti-nuclear antibody (ANA) titer greater than or equal to 1:80 ; or
- Anti double strand DNA antibody (anti-dsDNA) greater than or equal to 30 IU/mL ; and
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) ;and
Individual is not receiving any other biologic agent.

Reauthorization Criteria

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

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.

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

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

M32.10

M32.11

M32.12

M32.13

M32.15

M32.19

M32.8

M32.9

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-19-2024 Effective December 09, 2024

Adopted Medicaid Expansion specific policy

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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