Saphnelo (Anifrolumab-Fnia) (for Ohio Only)
Defines UnitedHealthcare Ohio coverage criteria for Saphnelo for adults with moderate to severe systemic lupus erythematosus (SLE), including initial and continuation authorization requirements and applicable coding guidance.
No material clinical or coverage changes in this revision.
Coverage Criteria for Saphnelo (anifrolumab-fnia)
Initial Therapy — Covered when ALL of the following are met for initial therapy
Covered when ALL of the following are met for initial therapy:
Continuation Therapy — Covered when ALL of the following are met for continuation of therapy
Covered when ALL of the following are met for continuation of therapy:
Coverage is limited for patients with severe active lupus nephritis and severe active central nervous system (CNS) lupus; these uses are listed as excluded/unproven and are not covered. The policy also excludes use of Saphnelo in combination with other biologic agents (concurrent biologic therapy is not recommended).
Requests that specify treatment for severe active lupus nephritis, severe active CNS lupus, or concomitant use of Saphnelo with other biologics are subject to denial as these indications are considered unproven and not medically necessary.
Saphnelo is specifically described in the policy as unproven and not medically necessary for the following situations: severe active lupus nephritis, severe active CNS lupus, and use in combination with other biologic therapies.
The limitations reflect that efficacy has not been evaluated in patients with severe active lupus nephritis or severe active CNS lupus and that concurrent use with other biologic agents is not recommended; therefore such uses do not meet medical necessity criteria under this policy.
Coding
| J0491 | Injection, anifrolumab-fnia, 1 mg. |
| M32.10 | Systemic lupus erythematosus, organ or system involvement unspecified. |
| M32.11 | Endocarditis in systemic lupus erythematosus. |
| M32.12 | Pericarditis in systemic lupus erythematosus. |
| M32.13 | Lung involvement in systemic lupus erythematosus. |
| M32.14 | Glomerular disease in systemic lupus erythematosus. |
| M32.15 | Tubulo-interstitial nephropathy in systemic lupus erythematosus. |
| M32.19 | Other organ or system involvement in systemic lupus erythematosus. |
| M32.8 | Other forms of systemic lupus erythematosus. |
| M32.9 | Systemic lupus erythematosus, unspecified. |
Provider Actions, Authorization, and Documentation
Prior Authorization Required
Prior authorization is required for Saphnelo (anifrolumab-fnia). Initial and continuation approvals are limited to no more than 12 months and must include documentation supporting the covered criteria.
- Initial and continuation authorizations: maximum 12 months
- Prescriber: rheumatologist or in consultation with a rheumatologist
Step Therapy Required
A step-therapy requirement applies: patient must have a prior trial with documented failure, contraindication, or intolerance to Benlysta (IV or SQ) before initiating Saphnelo.
- Required prior agent: Benlysta (belimumab) — IV or SQ
- Documentation must indicate failure, contraindication, or intolerance
Required Documentation
Documentation must include diagnosis and treatment history to support medical necessity for Saphnelo.
- Diagnosis: moderate to severe systemic lupus erythematosus (ICD-10 codes such as M32.* as applicable)
- Evidence patient is receiving at least one standard-of-care non-biologic therapy (e.g., antimalarials, corticosteroids, immunosuppressants)
- Details of prior trial and failure/contraindication/intolerance to Benlysta (IV or SQ)
- Evidence of positive clinical response for continuation requests
- Dosing consistent with FDA-labeled dosing for SLE
- Statement patient is not receiving Saphnelo in combination with another biologic or Benlysta
Denial Triggers / Not Medically Necessary
Use of Saphnelo in the following situations is considered unproven and not medically necessary and will be a denial trigger.
- Severe active lupus nephritis
- Severe active central nervous system (CNS) lupus
- Use in combination with other biologic therapies (including concurrent use with Benlysta)
Background
Saphnelo (anifrolumab-fnia) is a human monoclonal antibody that targets the type I interferon receptor; blocking this pathway is intended to reduce interferon-driven inflammation implicated in systemic lupus erythematosus. The policy notes that the efficacy has not been evaluated in patients with severe active lupus nephritis or severe active CNS lupus, and therefore its use is not recommended in those settings. Additionally, the medication is not recommended for use with other biologic therapies.
Definitions
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