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Prior Authorization Criteria for Anifrolumab-fnia (Saphnelo) and Belimumab (Benlysta) Effective March 1, 2022

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Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to eligible clients. Administrative procedures such as prior authorization, precertification, referrals, and claims/encounter data filing may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the client's specific MCO for details.

Effective for dates of service on or after March 1, 2022, prior authorization is required for anifrolumab-fnia (Saphnelo) procedure code C9086 and belimumab (Benlysta) procedure code J0490.

Anifrolumab-fnia (Saphnelo)

Anifrolumab-fnia (Saphnelo) is indicated to treat moderate to severe systemic lupus erythematosus (SLE) in adult clients who are receiving standard therapy.

Belimumab (Benlysta)

Belimumab (Benlysta) is indicated to treat the following:

  • Active, autoantibody-positive SLE in clients who are 5 years old or older and receiving standard therapy
  • Adult clients with active lupus nephritis who are receiving standard therapy

Initial Requests

Initial therapy for anifrolumab-fnia (Saphnelo) may be approved for a 12-month duration if all the following criteria are met:

  • The client is 18 years old or older.
  • The client has a confirmed diagnosis of systemic lupus erythematosus (M3210, M3211, M3212, M3213, M3214, M3215, M3219, M328, M329).
  • The client does not have active lupus nephritis or severe active central nervous lupus.
  • The client is currently receiving at least one stable standard-of-care treatment for active systemic lupus erythematosus.
  • The client is not receiving anifrolumab-fina (Saphnelo) in combination with a biologic agent.

Initial therapy for belimumab (Benlysta) may be approved for a 12-month duration if all the following criteria are met:

  • Diagnosis of SLE:
    • The client is 5 years old or older.
    • The client has a confirmed diagnosis of SLE (M320, M3210, M3211, M3212, M3213, M3214, M3215, M3219, M328, M329).
    • The client has laboratory testing confirming the presence of autoantibodies.
    • The client is currently receiving at least one standard-of-care treatment for active SLE.
    • The client is not receiving belimumab (Benlysta) in combination with a biologic disease-modifying antirheumatic drug (DMARD) agent.
  • Diagnosis of active lupus nephritis:
    • The client is 18 years old or older.
    • The adult client has a confirmed diagnosis of active lupus nephritis.
    • The client has laboratory testing confirming the presence of autoantibodies.
    • The client is currently receiving at least one standard-of-care treatment.
    • The client is not receiving belimumab (Benlysta) in combination with a biologic DMARD agent.

Recertification or Extension

For renewal or continuation therapy for anifrolumab-fnia (Saphnelo), the client must meet the following criteria:

  • The client continues to meet the initial authorization approval criteria.
  • The client has experienced a positive clinical response to therapy as demonstrated by stabilization of the disease or absence of disease progression.
  • The client has not experienced any complications or unacceptable toxicities during anifrolumab-fnia (Saphnelo) treatment.

For renewal or continuation therapy for belimumab (Benlysta), the client must meet the following criteria:

  • The client continues to meet the initial authorization approval criteria.
  • The client has experienced a positive clinical response to therapy as demonstrated by stabilization of the disease or absence of disease progression.
  • The client has not experienced any complications or unacceptable toxicities during belimumab (Benlysta) treatment.

For more information, call the TMHP Contact Center at 800-925-9126.