Prior Authorization and Duration

Prior authorization is required for Ilaris and initial approvals will be issued for no more than 12 months. Reauthorization (continuation) approvals will also be limited to no more than 12 months. Verify that dosing follows the U.S. FDA–approved labeling for the specific indication. Requests for continuation must include documentation of a positive clinical response to therapy.

• Initial and reauthorization approvals limited to <= 12 months
• Dosing must follow U.S. FDA–approved labeling for the treated indication
• Continuation requests require documentation of positive clinical response

Prior Authorization Required / Benefit Plan Dependency

Prior authorization is required and coverage is subject to review of member-specific benefits and any applicable federal or state mandates. Coverage determinations follow the member's benefit plan; when a conflict exists, the member-specific benefit plan governs. Some state or federal mandates may require coverage for certain off-label uses — check the member's plan and applicable mandates before approving or denying.

• Coverage decisions must reference the member-specific benefit plan document
• Check for state or federal mandates that may supersede plan language
• Off-label uses may be excluded unless mandated by law or the member's plan

Diagnoses and Supporting Documentation

Providers must document the specific diagnosis (ICD-10 code) and supporting clinical evidence demonstrating medical necessity. For inflammatory and autoinflammatory indications, documentation should include specialist involvement (e.g., rheumatologist or immunologist) where indicated, prior treatment trials or contraindications/intolerance, and clinical response to prior therapy when applicable.

• Include the ICD-10 diagnosis code(s) relevant to the requested indication
• For diagnoses such as TRAPS, FMF, HIDS, MKD, AOSD, SJIA: diagnosis by or in consultation with a rheumatologist or immunologist is required
• Provide supporting clinical records (progress notes, labs, imaging) demonstrating disease activity and response to therapies

Member Plan and Mandate Check

Member-specific plan and applicable mandate checks are required prior to final coverage determination. Refer to the member's certificate of coverage and any state or federal mandate that may affect coverage for off-label indications or investigational therapies.

• Verify member-specific Certificate of Coverage or plan document
• Confirm whether state or federal mandates require coverage for off-label use
• When mandates apply, they supersede standard plan or policy language

Step Therapy Requirements

Step therapy requirements must be documented and met where specified by indication. For Familial Mediterranean Fever (FMF), there must be a history of failure, contraindication, or intolerance to colchicine before Ilaris is authorized. For gout flares, patients must have a history of contraindication, intolerance, or treatment failure with both colchicine and an NSAID, and the provider must attest that systemic corticosteroids are not appropriate. Guideline-recommended first-line therapies (colchicine, NSAIDs, or glucocorticoids where appropriate) should be used before IL-1 inhibitors except when contraindicated or not tolerated.

• FMF: trial of colchicine (failure, contraindication, or intolerance) required prior to Ilaris
• Gout flares: trial or contraindication/intolerance to both colchicine and NSAIDs required; provider must attest systemic corticosteroids are not appropriate
• Gout flare authorization is typically for one dose covering up to 12 weeks per policy wording
• Follow ACR and relevant guideline sequencing: prefer colchicine/NSAIDs/glucocorticoids as first-line for gout flares before IL-1 inhibitors when clinically appropriate

Denial Risks and Combination Therapy Exclusion

Requests may be denied if required documentation is missing or if required prior trials/attestations are not provided. Additionally, requests for use in combination with targeted immunomodulators (examples: adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib) may be denied per policy criteria.

• Denial triggers include absent documentation of positive clinical response, missing specialist consultation when required, or lack of required prior therapy trials
• Combination therapy with specified targeted immunomodulators is excluded and may be denied