Colorado Rocky Mountain HP Ilaris Coverage Update

Coverage Criteria for Ilaris (canakinumab)

Cryopyrin-associated periodic syndromes (CAPS: FCAS, MWS)

Ilaris is medically necessary when ALL of the following are met:

CAPS initial therapy: Initial therapy: (1) Diagnosis of FCAS or MWS by, or in consultation with, a rheumatologist or immunologist with expertise in CAPS; AND (2) Ilaris dosing for FCAS/MWS is in accordance with United States FDA approved labeling; AND (3) Initial authorization will be for no more than 12 months.

CAPS continuation therapy: Continuation: (1) Patient is currently on Ilaris therapy for FCAS or MWS; AND (2) Ilaris dosing for FCAS/MWS is in accordance with United States FDA approved labeling; AND (3) Documentation of positive clinical response to Ilaris therapy; AND (4) Reauthorization will be for no more than 12 months.

Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS)

Ilaris is medically necessary when ALL of the following are met:

TRAPS initial therapy: Initial therapy: (1) Diagnosis of TRAPS by, or in consultation with, a rheumatologist or immunologist with expertise in TRAPS; AND (2) Ilaris dosing for TRAPS is in accordance with United States FDA approved labeling; AND (3) Initial authorization will be for no more than 12 months.

TRAPS continuation therapy: Continuation: (1) Patient is currently receiving Ilaris therapy for TRAPS; AND (2) Documentation of a positive clinical response to therapy; AND (3) Ilaris dosing for TRAPS is in accordance with United States FDA approved labeling; AND (4) Reauthorization will be for no more than 12 months.

Hyperimmunoglobulin D (HIDS)/Mevalonate Kinase Deficiency (MKD)

Ilaris is medically necessary when ALL of the following are met:

HIDS/MKD initial therapy: Initial therapy: (1) Diagnosis of HIDS or MKD by, or in consultation with, a rheumatologist or immunologist with expertise in HIDS/MKD; AND (2) Ilaris dosing for HIDS/MKD is in accordance with United States FDA approved labeling; AND (3) Initial authorization will be for no more than 12 months.

HIDS/MKD continuation therapy: Continuation: (1) Patient is currently receiving Ilaris for HIDS or MKD; AND (2) Documentation of a positive clinical response to therapy; AND (3) Ilaris dosing for HIDS/MKD is in accordance with United States FDA approved labeling; AND (4) Reauthorization will be for no more than 12 months.

Familial Mediterranean Fever (FMF)

Ilaris is medically necessary when ALL of the following are met:

FMF initial therapy: Initial therapy: (1) Diagnosis of Familial Mediterranean Fever (FMF) by, or in consultation with, a rheumatologist or immunologist with expertise in FMF; AND (2) History of failure, contraindication, or intolerance to colchicine; AND (3) Ilaris dosing for FMF is in accordance with United States FDA approved labeling; AND (4) Initial authorization will be for no more than 12 months.

FMF continuation therapy: Continuation: (1) Patient is currently receiving Ilaris for FMF; AND (2) Documentation of a positive clinical response to therapy; AND (3) Ilaris dosing for FMF is in accordance with United States FDA approved labeling; AND (4) Reauthorization will be for no more than 12 months.

Active Still's Disease (AOSD/SJIA)

Ilaris is medically necessary when ALL of the following are met:

AOSD/SJIA initial therapy: Initial therapy: (1) Diagnosis of adult-onset Still's disease (AOSD) or systemic juvenile idiopathic arthritis (SJIA) by, or in consultation with, a rheumatologist or immunologist with expertise; AND (2) Ilaris dosing for AOSD/SJIA is in accordance with United States FDA approved labeling; AND (3) Patient is not receiving Ilaris in combination with a targeted immunomodulator (e.g., adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib); AND (4) Initial authorization will be for no more than 12 months.

AOSD/SJIA continuation therapy: Continuation: (1) Patient is currently receiving Ilaris for AOSD/SJIA; AND (2) Documentation of a positive clinical response to therapy; AND (3) Ilaris dosing for AOSD/SJIA is in accordance with United States FDA approved labeling; AND (4) Patient is not receiving Ilaris in combination with a targeted immunomodulator; AND (5) Reauthorization will be for no more than 12 months.

Gout Flares

Ilaris is medically necessary when ALL of the following are met:

Gout flare requirements: Diagnosis of a gout flare; AND history of contraindication, intolerance, or treatment failure with both colchicine AND a non-steroidal anti-inflammatory drug (NSAID); AND provider attests the patient is not an appropriate candidate for systemic corticosteroids; AND Ilaris dosing is in accordance with United States FDA labeled dosing for gout flares; AND authorization will be issued for one dose for 12 weeks.

Gout additional prescriber requirement: For one formulation of the gout flare criteria: prescriber is a rheumatologist or nephrologist (prescription by these specialists is specified in the document); AND other gout flare requirements above are met.

Coverage when clinical and FDA-labeled criteria are met

Covered when consistent with FDA indications and relevant clinical context:

FDA-indications: Ilaris (canakinumab) is indicated for CAPS (in patients ≥4 years), TRAPS, HIDS/MKD, FMF, SJIA (≥2 years), AOSD, and symptomatic treatment of gout flares in adults when NSAIDs and colchicine are contraindicated, not tolerated, or ineffective; repeated corticosteroid courses are not appropriate.

FDA indications summarized from document.

Gout-specific prior therapy: For gout flares, patient should have contraindication, intolerance, or inadequate response to NSAIDs and/or colchicine; pivotal studies enrolled patients with ≥3 flares in the previous year.≥3 flares in previous year (trial population)

Guideline and trial context referenced.

SJIA disease activity: SJIA trial eligibility included active systemic features (fever, ≥2 active joints), CRP > 30 mg/L, and glucocorticoid dose ≤1.0 mg/kg/day; these trial-based criteria may inform consideration for therapy.

Requests for Ilaris (canakinumab) to manage or treat cardiovascular disease are considered not proven and not medically necessary. Such uses fall outside the conditions enumerated as medically necessary in this policy and would be denied.

For gout flares, IL-1 inhibitors (including Ilaris) are not first-line therapies. Guideline-preferred first-line options are oral colchicine, NSAIDs, or glucocorticoids as appropriate based on patient factors. IL-1 inhibition is reserved for patients who cannot tolerate or have contraindications to first-line agents, or who had inadequate response to those agents; documentation should support intolerance, contraindication, or treatment failure with both colchicine and a NSAID (and that systemic corticosteroids are not appropriate) before Ilaris is considered.

FDA approval or labeling alone does not by itself establish coverage. The policy uses FDA indications for informational context, but coverage determinations also require assessment of the clinical circumstances and adherence to the policy's medical necessity criteria and any applicable member-specific benefit terms.

Use of IL-1 inhibitors for gout flares when a patient can tolerate and has not failed guideline-preferred first-line therapies would not align with recommended care. Specifically, if the patient has not tried or cannot demonstrate failure/intolerance/contraindication to colchicine and a NSAID, and systemic corticosteroids remain an appropriate option, use of Ilaris for the flare is not consistent with guideline-preferred management and may be considered not medically necessary.

Applicable Coding

Applicable HCPCSHCPCS

J0638

Injection, canakinumab, 1 mg

Applicable ICD-10 (examples; list in document continues)ICD-10

M04.1	Periodic fever syndromes.
M04.2	Cryopyrin-associated periodic syndromes.
M06.1	Adult-onset Still's disease.
M08.20	Juvenile rheumatoid arthritis with systemic onset, unspecified site.
M10.00	Idiopathic gout, unspecified site.

Applicable ICD-10 Codes (gout and subtypes)ICD-10

M10.222	Drug-induced gout, left elbow
M10.229	Drug-induced gout, unspecified elbow
M10.231	Drug-induced gout, right wrist
M10.232	Drug-induced gout, left wrist
M10.239	Drug-induced gout, unspecified wrist
M10.241	Drug-induced gout, right hand
M10.242	Drug-induced gout, left hand
M10.249	Drug-induced gout, unspecified hand
M10.251	Drug-induced gout, right hip
M10.252	Drug-induced gout, left hip

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inv-15: SJIA CRP inclusion — > 30 mg per liter

SJIA CRP threshold used in trials> 30 mg per liter

SJIA trial systemic featuresFever; ≥2 active joints; CRP > 30 mg per liter; glucocorticoid dose ≤1.0 mg/kg/day

Pediatric dosing contextTrial used single subcutaneous dose 4 mg/kg in patients aged 2–19 years

inv-16: CAPS/SAA or CRP normalization — < 10 mg/L

CRP/SAA normalization threshold< 10 mg/L

Time to normalization in CAPS studyMedian CRP and SAA values were normal (< 10 mg per liter) by end of part 2 and sustained in many patients

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of Ilaris (canakinumab) for FDA‑labeled indications. Initial and reauthorization approvals are generally limited to up to 12 months; for gout flares authorization will be issued for one dose covering 12 weeks.

Prior authorization required for initiation and continuation
Typical approval length: up to 12 months for chronic indications; gout flare: one dose for 12 weeks

Denial Risk

Indications Aligned with FDA Labeling; Excluded Indications

Ilaris is indicated and covered only for FDA‑labeled indications (CAPS/FCAS/MWS, TRAPS, HIDS/MKD, FMF, SJIA/AOSD, and symptomatic gout flares in adults meeting criteria). Requests for Ilaris for cardiovascular disease or other non‑supported indications are not proven or medically necessary and will be denied.

Definitions and Indication Summaries

inv-31: Indications listed — Document enumerates indications covered

Indications enumeratedCryopyrin-associated periodic syndromes (FCAS, MWS); TRAPS; HIDS/MKD; Familial Mediterranean Fever (FMF); Active Still's disease (AOSD and SJIA); gout flares

CAPS subtypes listedFamilial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS)

Gout flare criteria includedSymptomatic gout flares when colchicine and NSAIDs are contraindicated, not tolerated, or ineffective

inv-32: CAPS — Cryopyrin-Associated Periodic Syndromes

DefinitionCryopyrin-Associated Periodic Syndromes (CAPS) are rare autosomal dominant syndromes caused by NLRP3 mutations characterized by fever, urticaria-like rash, arthralgia, myalgia, fatigue, and conjunctivitis driven by excess IL-1β

Examples

Background

Canakinumab (Ilaris) is a recombinant human monoclonal antibody that neutralizes interleukin‑1β (IL‑1β). It is FDA‑labeled for several rare autoinflammatory conditions — including Cryopyrin‑Associated Periodic Syndromes (CAPS; e.g., FCAS and Muckle‑Wells), TRAPS, HIDS/MKD, and Familial Mediterranean Fever (FMF) — and for active Still's disease (AOSD and SJIA) as well as for symptomatic treatment of gout flares in adults meeting specified prior‑therapy criteria. The policy considers Ilaris medically necessary for these FDA‑labeled indications when the documented clinical criteria and dosing per FDA labeling are met, and when required specialist consultation, prior therapy history, and evidence of clinical response for continuation are provided.

Policy Revision History

11/01/2025policy updatedLatest

Updated Background, FDA, and References sections; archived previous policy version 2024D0066K.

OpenPayer

Ilaris (canakinumab) — Medical Benefit Drug Coverage Criteria

Coverage Criteria for Ilaris (canakinumab)

Applicable Coding

Prior Authorization, Documentation, and Step Therapy

Definitions and Indication Summaries

Background

Policy Revision History