Centene canakinumab (Ilaris) Coverage Update

Coverage Criteria for Canakinumab (Ilaris)

Initial Therapy - Periodic Fever Syndromes

Covered when ALL of the following are met

Periodic Fever Syndromes initial criteria: 1. Diagnosis of FCAS, MWS, TRAPS, HIDS/MKD, or FMF; 2. Prescribed by or in consultation with a rheumatologist; 3. Age requirement: FCAS or MWS ≥ 4 years OR TRAPS, HIDS/MKD, or FMF ≥ 2 years; 4. Documentation of disease-specific activity (see disease activity definitions); 5. No combination use with biological disease-modifying antirheumatic drugs (bDMARDs) or Janus kinase (JAK) inhibitors; 6. Dose does not exceed indication-specific limits (see dosing subcriteria).

See Disease activity definitions block for required activity documentation and Appendix V for weight-based dosing limits.

Disease activity definitions

Disease activity: One of the following must be documented: a) FCAS: classic signs and symptoms (e.g., recurrent, intermittent fever and rash often exacerbated by cold exposure) AND functional impairment limiting activities of daily living; b) MWS: classic signs and symptoms (e.g., chronic waxing/waning fever and rash) AND functional impairment limiting activities of daily living; c) TRAPS: chronic or recurrent disease activity with ≥ 6 flares in the last 12 months; d) HIDS/MKD: ≥ 3 febrile acute flares within the last 6 months; e) FMF: active disease with ≥ 1 flare per month AND either (i) age < 4 years OR (ii) failure of a ≥ 6-month trial of colchicine at up to maximally indicated doses unless contraindicated or not tolerated.

Illinois HIM step therapy exception applies per policy notes.

Initial Therapy - SJIA

Covered when ALL of the following are met

SJIA initial criteria: 1. Diagnosis of systemic juvenile idiopathic arthritis (SJIA); 2. Prescribed by or in consultation with a dermatologist, rheumatologist, or gastroenterologist; 3. Age ≥ 2 years; 4. One of the following unless previously failed a biologic for SJIA: a) Failure of a ≥ 3 consecutive month trial of methotrexate or leflunomide at up to maximally indicated doses; b) Failure of a ≥ 2-week trial of systemic corticosteroid at up to maximally indicated doses; c) Failure of an NSAID at up to maximally indicated doses; 5. No combination use with bDMARDs or JAK inhibitors; 6. Dose does not exceed both: a) 300 mg every 4 weeks; b) 2 vials every 4 weeks.

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to renewal date.

Initial Therapy - AOSD

Covered when ALL of the following are met

AOSD initial criteria: 1. Diagnosis of adult-onset Still's disease (AOSD); 2. Prescribed by or in consultation with a rheumatologist or hematologist; 3. Age ≥ 18 years; 4. One of the following: a) Failure of a ≥ 2-week trial of systemic corticosteroid at up to maximally indicated doses; b) Failure of an NSAID at up to maximally indicated doses; 5. No combination use with bDMARDs or JAK inhibitors; 6. Dose does not exceed both: a) 300 mg every 4 weeks; b) 2 vials every 4 weeks.

Approval duration consistent with SJIA: Medicaid/HIM 12 months; Commercial 6 months or to renewal date.

Initial Therapy - Acute Gout Flare

Covered when ALL of the following are met

Gout flare criteria: 1. Diagnosis of acute gout flare; 2. Age ≥ 18 years; 3. Failure of colchicine unless contraindicated or not tolerated; 4. Failure of an NSAID used for gout flare (e.g., naproxen, indomethacin, sulindac) unless contraindications exist (a) heart failure or uncontrolled hypertension; (b) current use of an anticoagulant; (c) active duodenal or gastric ulcer; or (d) chronic kidney disease with CrCl < 60 mL/min/1.73 m2; 5. Failure of a corticosteroid used for gout flare and repeated corticosteroid courses are not appropriate; 6. Member is currently taking or will initiate a urate-lowering therapy (e.g., allopurinol, febuxostat, or probenecid) unless contraindicated; 7. No combination use with bDMARDs or JAK inhibitors; 8. Dose does not exceed 150 mg per 12 weeks.

Approval duration: 3 months.

Continuation Therapy - Acute Gout Flare

Gout continuation: 1. Member is currently receiving medication via Centene benefit or previously met initial approval criteria OR member is in a continuity-of-care state/product; 2. Member is responding positively to therapy; 3. Member is currently prescribed a urate-lowering agent (e.g., allopurinol, febuxostat, or probenecid) unless contraindicated; 4. Previous Ilaris dose was administered ≥ 12 weeks prior; 5. No combination use with bDMARDs or JAK inhibitors; 6. Dose does not exceed 150 mg per 12 weeks.

Approval duration: Medicaid/HIM 6 months; Commercial 6 months or to renewal date.

Continuation Therapy - Other Indications

Continuation Therapy - Other Indications in Section I

Other continuation: 1. Member is currently receiving medication via Centene benefit or previously met initial approval criteria OR member is in a continuity-of-care state/product; 2. Member is responding positively to therapy; 3. Member does not have combination use with bDMARDs or JAK inhibitors; 4. If request is for a dose increase, new dose must not exceed indication-specific maximums (see dosing tables for FCAS/MWS, TRAPS/HIDS/MKD/FM F, SJIA, AOSD).

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to renewal date.

Initial and diagnosis-specific coverage

Coverage is provided for specific diagnoses when dosing and clinical criteria are met; dosing is diagnosis- and weight-specific.

Covered Indications (examples): CAPS (FCAS and MWS), TRAPS, HIDS/MKD, FMF, systemic juvenile idiopathic arthritis (SJIA), adult-onset Still's disease (AOSD), and gout flares are covered when the clinical criteria and dosing by weight are met.

See Appendix V: Dosage and Administration for weight-based regimens and maximum doses (e.g., CAPS: 2–3 mg/kg q8w or 150 mg q8w; TRAPS/HIDS/MKD/FM F: 2–4 mg/kg q4w or up to 300 mg q4w; SJIA/AOSD: 4 mg/kg up to 300 mg q4w; gout: 150 mg with ≥12 week interval).

Not authorized: combination with other potent immunosuppressants

Not authorized uses

Combination therapy exclusion: Use in combination with biological disease-modifying antirheumatic drugs (bDMARDs), Janus kinase inhibitors (JAKi), anti-CD20 antibodies, selective co-stimulation modulators, integrin receptor antagonists, tyrosine kinase 2 (TYK2) inhibitors, sphingosine 1-phosphate (S1P) modulators, and other listed biologics is not authorized due to additive immunosuppression, increased risk of neutropenia, and increased risk of serious infections.

Specific agents and examples are enumerated in Section III.B.

Requests for use of canakinumab for non‑FDA approved indications that are not specifically addressed in this policy will be excluded unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Canakinumab must not be used in combination with biological disease‑modifying antirheumatic drugs (bDMARDs), Janus kinase inhibitors (JAKi), anti‑CD20 monoclonal antibodies, selective co‑stimulation modulators, integrin receptor antagonists, TYK2 inhibitors, S1P receptor modulators, or other potent immunomodulatory biologics listed in Section III.B. Such combination use is not authorized due to the risk of additive immunosuppression, neutropenia, and serious infections.

Canakinumab is contraindicated in members with a confirmed hypersensitivity to canakinumab or any of its excipients. There are no boxed warnings reported for canakinumab in this policy.

Use of canakinumab in combination with other potent immunosuppressants or biologic agents is considered not authorized because concurrent administration can produce additive immunosuppression and increase the risk of neutropenia and serious infections; therefore combination regimens will be denied.

Specifically, concurrent use of canakinumab with the enumerated biologic or potent immunosuppressive agents (including but not limited to TNF antagonists, interleukin inhibitors/antagonists, JAK inhibitors, anti‑CD20 antibodies, selective co‑stimulation modulators, integrin receptor antagonists, TYK2 inhibitors, and S1P modulators) is deemed not medically necessary due to documented safety concerns such as additive immunosuppression, neutropenia, and increased serious infection risk.

Coding and Dosing Information

Policy identifiermixed

CP.PHAR.246

Policy reference number

HCPCS CodesHCPCS

J0638

Injection, canakinumab, 1 mg

Dosing thresholds by weight and indication

CAPS (FCAS, MWS) — weight 15–40 kg2–3 mg/kg subcutaneously every 8 weeks (2 mg/kg; may increase to 3 mg/kg if inadequate response).

CAPS (FCAS, MWS) — weight >40 kg150 mg subcutaneously every 8 weeks (maximum 150 mg/8 weeks).

TRAPS, HIDS/MKD, FMF — weight ≤40 kg2–4 mg/kg subcutaneously every 4 weeks (start 2 mg/kg; may increase to 4 mg/kg if inadequate response).

TRAPS, HIDS/MKD, FMF — weight >40 kg150 mg subcutaneously every 4 weeks (may increase to 300 mg every 4 weeks if inadequate response).

SJIA and AOSD — weight ≥7.5 kg4 mg/kg subcutaneously every 4 weeks up to a maximum of 300 mg every 4 weeks (dose limits: ≤300 mg and ≤2 vials every 4 weeks for SJIA).

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must demonstrate that the member meets the indication-specific criteria (diagnosis, prescriber specialty or consultation, age limits, prior therapies/step therapy where applicable) described in the policy. Approval durations vary by line of business (Medicaid/HIM: 12 months; Commercial: 6 months or to the member's renewal date, whichever is longer).

Prior authorization must document indication, prescriber specialty/consultation, age, and prior therapy trials when required.
Approval duration: Medicaid/HIM = 12 months; Commercial = 6 months or to member renewal date.

Billing Rule

Prior Authorization and Coding

Providers must include appropriate coding information when submitting prior authorization requests and claims. The HCPCS code referenced for canakinumab is J0638 (Injection, canakinumab, 1 mg). Codes in the policy are informational; providers should verify current coding guidance prior to claim submission.

Background and Drug Description

Canakinumab (Ilaris) is a monoclonal antibody that targets interleukin‑1β, reducing IL‑1 mediated inflammation. It is FDA‑approved for several autoinflammatory periodic fever syndromes (for example, FCAS and MWS within the CAPS spectrum), systemic juvenile idiopathic arthritis (sJIA), adult‑onset Still’s disease (AOSD), and for certain acute gout flares when standard therapies are contraindicated or have failed. Note that therapy is subject to indication‑specific age limits, prior‑therapy requirements, and dosing limits as described elsewhere in this policy; contraindication exists for confirmed hypersensitivity and no boxed warnings are reported.

Definitions and Acronyms

Acronyms and conditions

CAPSCryopyrin-associated periodic syndromes (includes FCAS and MWS; NOMID/CINCA is related but not FDA-approved for Ilaris).

FCASFamilial cold autoinflammatory syndrome — a CAPS subtype characterized by fever and rash often triggered by cold exposure.

MWSMuckle-Wells syndrome — a CAPS subtype with chronic fever and waxing/waning rash and systemic symptoms.

TRAPSTumor necrosis factor receptor associated periodic syndrome — an autoinflammatory periodic fever syndrome included in Ilaris indications.

HIDS/MKDHyperimmunoglobulin D syndrome / mevalonate kinase deficiency — an autoinflammatory periodic fever syndrome included in Ilaris indications.

FMFFamilial Mediterranean fever — an autoinflammatory disease; standard therapy is colchicine.

OpenPayer

Canakinumab (Ilaris) coverage

Coverage Criteria for Canakinumab (Ilaris)

Coding and Dosing Information

Provider Actions, Prior Authorization, and Documentation

Background and Drug Description

Definitions and Acronyms