UnitedHealthcare Ilaris (canakinumab) Coverage Update

Coverage Criteria for Ilaris (canakinumab)

CAPS (FCAS, MWS)

Ilaris is proven and medically necessary for CAPS (FCAS and MWS) when ALL of the following are met

CAPS Initial Therapy: For initial therapy: diagnosis of FCAS or MWS by, or in consultation with, a rheumatologist or immunologist with expertise; Ilaris dosing for FCAS/MWS is in accordance with the United States Food and Drug Administration approved labeling; initial authorization will be for no more than 12 months

CAPS Continuation Therapy: For continuation of therapy: patient is currently on Ilaris therapy for FCAS or MWS; Ilaris dosing for FCAS/MWS is in accordance with the United States Food and Drug Administration approved labeling; documentation of positive clinical response to Ilaris therapy; reauthorization will be for no more than 12 months

TRAPS

Ilaris is proven and medically necessary for TRAPS when ALL of the following are met

TRAPS Initial Therapy: Diagnosis of TRAPS by, or in consultation with, a rheumatologist or immunologist with expertise in TRAPS; Ilaris dosing for TRAPS is in accordance with the United States Food and Drug Administration approved labeling; initial authorization will be for no more than 12 months

TRAPS Continuation Therapy: For continuation of therapy: patient is currently receiving Ilaris for TRAPS; documentation of a positive clinical response to therapy; Ilaris dosing for TRAPS is in accordance with the United States Food and Drug Administration approved labeling; reauthorization will be for no more than 12 months

HIDS / MKD

Ilaris is proven and medically necessary for HIDS/MKD when ALL of the following are met

HIDS/MKD Initial Therapy: For initial therapy: diagnosis of HIDS or MKD by, or in consultation with, a rheumatologist or immunologist with expertise; Ilaris dosing for HIDS/MKD is in accordance with the United States Food and Drug Administration approved labeling; initial authorization will be for no more than 12 months

HIDS/MKD Continuation Therapy: For continuation of therapy: patient is currently receiving Ilaris for HIDS or MKD; documentation of a positive clinical response to therapy; Ilaris dosing for HIDS/MKD is in accordance with the United States Food and Drug Administration approved labeling; reauthorization will be for no more than 12 months

FMF

Ilaris is proven and medically necessary for Familial Mediterranean Fever (FMF) when ALL of the following are met

FMF Initial Therapy: For initial therapy: diagnosis of FMF by, or in consultation with, a rheumatologist or immunologist with expertise; history of failure, contraindication, or intolerance to colchicine; Ilaris dosing for FMF is in accordance with the United States Food and Drug Administration approved labeling; initial authorization will be for no more than 12 months

FMF Continuation Therapy: For continuation of therapy: patient is currently receiving Ilaris for FMF; documentation of a positive clinical response to therapy; Ilaris dosing for FMF is in accordance with the United States Food and Drug Administration approved labeling; reauthorization will be for no more than 12 months

Active Still's disease (AOSD, SJIA)

Ilaris is proven and medically necessary for active Still's disease (AOSD and SJIA) when ALL of the following are met

AOSD/SJIA Initial Therapy: For initial therapy: diagnosis of AOSD or SJIA by, or in consultation with, a rheumatologist or immunologist with expertise; Ilaris dosing for AOSD/SJIA is in accordance with the United States Food and Drug Administration approved labeling; patient is not receiving Ilaris in combination with a targeted immunomodulator (e.g., adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib); initial authorization will be for no more than 12 months

Examples of targeted immunomodulators are listed in the policy

AOSD/SJIA Continuation Therapy: For continuation of therapy: patient is currently receiving Ilaris for AOSD/SJIA; documentation of a positive clinical response to therapy; Ilaris dosing for AOSD/SJIA is in accordance with the United States Food and Drug Administration approved labeling; patient is not receiving Ilaris in combination with a targeted immunomodulator; reauthorization will be for no more than 12 months

Gout flares

Ilaris is proven and medically necessary for gout flares when ALL of the following are met

Gout Flare Criteria: Diagnosis of a gout flare; history of contraindication, intolerance, or treatment failure with both colchicine and non-steroidal anti-inflammatory drugs (NSAIDs); provider attests the patient is not an appropriate candidate for systemic corticosteroids; prescribed by a rheumatologist or nephrologist; Ilaris dosing is in accordance with the United States Food and Drug Administration labeled dosing for gout flares; authorization will be issued for one dose for 12 weeks

Authorization limit: one dose per 12 weeks; dosing and specialty prescriber requirements per FDA labeling and policy.

Contexts with trial-supported efficacy

Evidence-based contexts in which canakinumab demonstrated efficacy in trials:

CAPS: Canakinumab 150 mg every 8 weeks showed high complete response rates and sustained remission in CAPS patients across trials (Kuemmerle-Deschner: 78% complete response in canakinumab-naive patients; Lachmann: 97% complete response in part 1) with normalization of CRP/SAA and durable control.

Kuemmerle-Deschner and Lachmann trials cited

SJIA/AOSD: Canakinumab (4 mg/kg every 4 weeks) improved adapted JIA ACR30 response (84% at day 15 in trial 1) and reduced risk of flare versus placebo (74% no flare vs 25% placebo in withdrawal trial); trial entry CRP > 30 mg per liter was an eligibility criterion in Trial 1.CRP > 30 mg per liter

Trial results and safety signals (infections, macrophage activation syndrome) noted

FMF/HIDS/TRAPS: Randomized study demonstrated higher responder rates at week 16 for canakinumab versus placebo across FMF, HIDS/MKD, and TRAPS cohorts using 150 mg every 4 weeks in the trial design described; common adverse events were infections.

Coverage-aligned clinical criteria

Coverage consideration aligns with FDA indications and major society guidelines:

Gout flares (adults): Covered when ALL of the following are met: (1) patient is an adult experiencing a gout flare; AND (2) patient has contraindication to, intolerance of, or inadequate response to both NSAIDs and colchicine or when repeated courses of corticosteroids are not appropriate; AND (3) clinical documentation supports why first-line therapies are unsuitable.

Based on FDA indication and 2020 ACR gout management guidance prioritizing colchicine/NSAIDs/glucocorticoids over IL-1 inhibitors

Autoinflammatory syndromes and sJIA/AOSD: Considered for coverage when diagnosis is one of the FDA-labeled indications: CAPS (including FCAS and MWS), TRAPS, HIDS/MKD, FMF, active Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients meeting diagnostic criteria and documented clinical need.

FDA-approved indications referenced; see package insert for age limits and specifics

Juvenile idiopathic arthritis guidance role: For sJIA without MAS, IL-1 inhibitors are conditionally recommended as initial monotherapy per 2021 ACR guidance; IL-1 and IL-6 inhibitors are strongly recommended over conventional DMARDs for inadequate response to or intolerance of NSAIDs and/or glucocorticoids.

Ilaris (canakinumab) is not proven or medically necessary for the management or treatment of cardiovascular disease and requests for use in cardiovascular indications do not meet coverage criteria in this policy.

Coverage may be excluded or limited for uses considered experimental, investigational, or unproven; determination of coverage for such uses depends on the member’s specific benefit plan and any applicable state mandates that may require off‑label coverage.

Per guideline-based sequencing, IL‑1 inhibitors are not recommended as first-line therapy for gout flares. Oral colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs), or glucocorticoids are strongly recommended as first‑line options ahead of IL‑1 blockade.

Some clinical applications of Ilaris may be classified as experimental, investigational, or unproven and therefore not covered under this policy unless the member’s benefit language or a controlling state mandate provides coverage for the specific off‑label use.

When used for gout flares, IL‑1 inhibition should generally be reserved for patients who cannot tolerate, have contraindications to, or have inadequate responses to first‑line therapies (colchicine or NSAIDs), and for whom repeated corticosteroid courses are not appropriate. For gout flare coverage the policy requires documentation of these conditions and that dosing follows the FDA‑labeled regimen (authorization is typically for one dose for 12 weeks).

Coding and Diagnosis Codes

HCPCS Covered CodeHCPCSCovered

J0638

Injection, canakinumab, 1 mg

Diagnosis Codes (examples listed)ICD-10

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

ICD-10 Codes for gout and related gout subtypesICD-10

M10.069	Idiopathic gout, unspecified knee
M10.071	Idiopathic gout, right ankle and foot
M10.072	Idiopathic gout, left ankle and foot
M10.079	Idiopathic gout, unspecified ankle and foot
M10.08	Idiopathic gout, vertebrae
M10.09	Idiopathic gout, multiple sites
M10.10	Lead-induced gout, unspecified site
M10.111	Lead-induced gout, right shoulder
M10.112	Lead-induced gout, left shoulder
M10.119	Lead-induced gout, unspecified shoulder

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C-reactive protein (CRP) — trial entry threshold example

CRP entry threshold (SJIA trial 1)> 30 mg per liter (required entry criterion for SJIA trial 1)

Population contextPatients aged 2–19 years with systemic JIA and active systemic features (fever; ≥2 active joints) in trial 1

Associated trial dosingSingle subcutaneous dose of canakinumab 4 mg/kg in trial 1

Provider Actions, Prior Authorization, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior Authorization Required for Gout Flares: Ilaris prior authorization is required for treatment of gout flares. Requests must document that the patient meets clinical eligibility and step-therapy prerequisites; initial authorization is limited to a single dose with an authorization duration of up to 12 weeks.

Prior authorization required for initial and continuation therapy where applicable
Initial authorization for gout flare: one dose for 12 weeks

Documentation Required

Gout Flare Eligibility and Prior Therapy

Gout Flare Eligibility — Frequency and Prior Therapy: Verify that the member has a diagnosis of gout flare and clinical history consistent with study populations and the FDA indication. Document that the patient has experienced frequent flares and is unable to use first-line agents.

History of ≥3 gout flares in the prior 12 months is consistent with pivotal trials (document if available)

Background and Therapeutic Context

Canakinumab (Ilaris) is a recombinant human monoclonal antibody targeting interleukin‑1β (IL‑1β). It is approved for several autoinflammatory syndromes — including cryopyrin‑associated periodic syndromes (CAPS), TRAPS, HIDS/MKD, and familial Mediterranean fever (FMF) — and for active Still’s disease/systemic juvenile idiopathic arthritis in specified age groups, as well as for symptomatic treatment of gout flares in adults who meet the labeled criteria. Clinical trials demonstrated meaningful benefit in these populations (for example, rapid symptom improvement and increased remission/no‑flare rates in CAPS and sJIA/AOSD trials, and pain reduction for gout flares in patients unable to use standard therapies).

Definitions and Key Terms

Named indications considered for canakinumab

Included autoinflammatory syndromesCryopyrin-Associated Periodic Syndromes (CAPS; includes FCAS and MWS), TRAPS, HIDS/MKD, Familial Mediterranean Fever (FMF)

Included systemic inflammatory diseasesAdult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA)

Gout flaresSymptomatic treatment of gout flares in adults when NSAIDs and colchicine are contraindicated, not tolerated, or inadequate and repeated corticosteroid courses are not appropriate

Canakinumab (Ilaris) — mechanism

Mechanism of actionRecombinant human anti–IL-1β IgG1κ monoclonal antibody that binds IL-1β and neutralizes its activity (does not bind IL-1α or IL-1ra)

TargetInterleukin-1 beta (IL-1β)

Policy Revision History

2025-11-01Policy revisionLatest

Updated Background, FDA, and References sections; archived prior policy version IEXD0066.08.

OpenPayer

Ilaris (canakinumab) — Individual Exchange medical benefit coverage criteria