UnitedHealthcare Ilaris coverage update | OpenPayer

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UnitedHealthcare Ilaris coverage update | OpenPayer

Coverage Criteria for Ilaris (canakinumab)

CAPS (FCAS, MWS) initial and continuation criteria

Covered when ALL of the following are met

ALL of the following

Diagnosis: FCAS or MWS diagnosed by, or in consultation with, a rheumatologist or immunologist with expertise
Dosing: Ilaris dosing for FCAS/MWS is in accordance with the United States Food and Drug Administration approved labeling
Initial authorization duration: Initial authorization will be for no more than 12 months
Continuation requirements: Patient currently on Ilaris for FCAS/MWS with documentation of positive clinical response; reauthorization up to 12 months

ALL of the following

(For initial therapy): All initial therapy requirements above must be met

TRAPS initial and continuation criteria

Covered when ALL of the following are met

ALL of the following

Diagnosis: TRAPS diagnosed by, or in consultation with, a rheumatologist or immunologist with expertise in TRAPS
Dosing: Ilaris dosing for TRAPS is in accordance with the United States Food and Drug Administration approved labeling
Initial authorization duration: Initial authorization will be for no more than 12 months
Continuation: Patient currently receiving Ilaris for TRAPS with documentation of positive clinical response; reauthorization up to 12 months

HIDS/MKD initial and continuation criteria

Covered when ALL of the following are met

ALL of the following

Diagnosis: HIDS or MKD diagnosed by, or in consultation with, a rheumatologist or immunologist with expertise
Dosing: Ilaris dosing for HIDS/MKD is in accordance with the United States Food and Drug Administration approved labeling
Initial authorization duration: Initial authorization will be for no more than 12 months
Continuation: Patient currently receiving Ilaris for HIDS/MKD with documentation of positive clinical response; reauthorization up to 12 months

Familial Mediterranean Fever (FMF) initial and continuation criteria

Covered when ALL of the following are met

ALL of the following

Diagnosis: FMF diagnosed by, or in consultation with, a rheumatologist or immunologist with expertise in FMF
Prior therapy: History of failure, contraindication, or intolerance to colchicine
Dosing: Ilaris dosing for FMF is in accordance with the United States Food and Drug Administration approved labeling
Initial authorization duration: Initial authorization will be for no more than 12 months

Active Still's disease (AOSD) and SJIA initial and continuation criteria

Covered when ALL of the following are met

ALL of the following

Diagnosis: AOSD or SJIA diagnosed by, or in consultation with, a rheumatologist or immunologist with expertise
Dosing: Ilaris dosing for AOSD/SJIA is in accordance with the United States Food and Drug Administration approved labeling
Combination therapy restriction: Patient is not receiving Ilaris in combination with a targeted immunomodulator (examples listed in policy)
Initial authorization duration: Initial authorization will be for no more than 12 months

Gout flare criteria

Covered when ALL of the following are met

ALL of the following

Diagnosis of a gout flare
Prior therapy: History of contraindication, intolerance, or treatment failure with both colchicine and non-steroidal anti-inflammatory drugs (NSAIDs)
Corticosteroid inappropriateness: Provider attests that the patient is not an appropriate candidate for systemic corticosteroids
Prescriber specialty: Prescribed by a rheumatologist or nephrologist

Clinical indications supported by trial data

Evidence-based indications supported by clinical trials

CAPS: Canakinumab demonstrated high rates of complete response and sustained normalization of CRP/SAA in CAPS patients (studies with canakinumab 150 mg every 8 weeks; response rates 78%-97% reported)

FMF, HIDS/MKD, TRAPS: Randomized double-blind study showed higher responder rates at week 16 with canakinumab (150 mg every 4 weeks) versus placebo and reduced index/new flares over 16 weeks

Systemic JIA / AOSD: Phase 3 RCTs and extension studies demonstrated efficacy of canakinumab (4 mg/kg subcutaneously every 4 weeks) in SJIA with improved adapted JIA ACR responses and reduced flare risk in withdrawal trial; extension studies showed sustained/increased inactive disease over time

Gout flares: Three randomized 12-week trials showed canakinumab 150 mg SC reduced pain intensity at 72 hours and decreased risk of new flares versus triamcinolone acetonide in patients unable to use NSAIDs and/or colchicine or with ≥3 flares in prior year

Gout flare — medically necessary when — Coverage aligns with FDA indications and rheumatology guideline recommendations

Coverage aligns with FDA indications and rheumatology guideline recommendations; for gout flares, coverage when ALL of the following are documented:

ALL of the following

Adult patient: Patient is an adult experiencing a gout flare (per FDA symptomatic gout-flare indication)
First-line therapies tried or contraindicated: Prior use of first-line therapies (oral colchicine, NSAIDs, or systemic/intraarticular/intramuscular glucocorticoids) is contraindicated, not tolerated, or ineffective
Corticosteroid consideration: Repeated courses of corticosteroids are inappropriate for the patient
Prior authorization documentation:

Systemic JIA — guideline recommendations

Guideline-based context for systemic juvenile idiopathic arthritis (sJIA):

sJIA therapeutic considerations: Biologic DMARDs (IL-1 and IL-6 inhibitors) are conditionally recommended as initial monotherapy for systemic JIA without MAS and strongly recommended over conventional synthetic DMARDs for inadequate response/intolerance to NSAIDs and/or glucocorticoids; no preferred agent specified.N/A

Informational for clinical decision-making

Ilaris (canakinumab) is not proven or medically necessary for the management or treatment of cardiovascular disease and use for this purpose is not supported by this policy.

Coverage decisions for Ilaris may be limited by the member's specific benefit plan. Member-specific Certificates of Coverage may restrict experimental, investigational, or unproven treatments, and state mandates for off-label use can supersede policy language; consult the member benefit document when making coverage determinations.

Use of canakinumab for gout flares is limited to the FDA‑labeled symptomatic indication: adults with a gout flare in whom NSAIDs and colchicine are contraindicated, not tolerated, or ineffective, and repeated courses of corticosteroids are not appropriate. Prior use and intolerance/contraindication to first‑line therapies should be documented when seeking coverage.

This document segment does not contain additional explicit statements designating other indications as not medically necessary beyond those noted in exclusions and benefit considerations.

For gout flares, guidelines and this policy expect sequencing of therapy: oral colchicine, NSAIDs, or systemic/intraarticular glucocorticoids are recommended as first‑line. IL‑1 inhibitors such as canakinumab are not recommended as first‑line therapy for most patients and should be reserved for patients who cannot tolerate or do not respond to guideline‑recommended first‑line agents or when corticosteroid courses are inappropriate.

Coding and Diagnosis References

HCPCSHCPCSCovered

J0638

Injection, canakinumab, 1 mg

Diagnosis codes (selected examples)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
M08.211	Juvenile rheumatoid arthritis with systemic onset, right shoulder
M08.212	Juvenile rheumatoid arthritis with systemic onset, left shoulder
M08.219	Juvenile rheumatoid arthritis with systemic onset, unspecified shoulder
M08.221	Juvenile rheumatoid arthritis with systemic onset, right elbow
M08.222	Juvenile rheumatoid arthritis with systemic onset, left elbow
M08.229	Juvenile rheumatoid arthritis with systemic onset, unspecified elbow

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1/3

Gout ICD-10 CodesICD-10

M10.011	Idiopathic gout, right shoulder
M10.012	Idiopathic gout, left shoulder
M10.019	Idiopathic gout, unspecified shoulder
M10.021	Idiopathic gout, right elbow
M10.022	Idiopathic gout, left elbow
M10.029	Idiopathic gout, unspecified elbow
M10.031	Idiopathic gout, right wrist
M10.032	Idiopathic gout, left wrist
M10.039	Idiopathic gout, unspecified wrist
M10.041	Idiopathic gout, right hand

1–10 of 119

1/12

History of gout flares — eligibility threshold

ThresholdAt least 3 gout flares in the prior 12 months

Source contextClinical trials enrolling gout flare patients required ≥3 flares in the previous year

Documentation expectationPrior authorization should include documented history of ≥3 flares in the prior year when supporting gout flare use

SJIA systemic activity baseline CRP — trial entry criterion

ThresholdBaseline C-reactive protein (CRP) > 30 mg per liter

ContextUsed as an entry criterion in SJIA randomized trial of canakinumab (patients aged 2–19 with active systemic features)

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization and Authorized Duration

Prior authorization required. Initial authorizations are generally limited to no more than 12 months for FDA‑labeled indications; gout flares receive single‑dose authorizations (one dose authorized for up to 12 weeks). Reauthorization/continuation requests must document ongoing clinical benefit and adherence to FDA‑approved dosing where applicable.

Initial authorization ≤ 12 months for labeled autoinflammatory indications (FCAS, MWS, TRAPS, HIDS/MKD, FMF, AOSD/SJIA)
Gout flares: authorization issued for one dose for 12 weeks
Reauthorization generally limited to ≤ 12 months and requires documentation of positive clinical response

Prior Authorization

Prior Authorization for Gout Flare Use

For gout flares, prior authorization must document that oral colchicine and NSAIDs have been tried and were contraindicated, not tolerated, or ineffective. If corticosteroids are being avoided, provider must attest that systemic corticosteroids are not appropriate. Prescriptions should be from an appropriate specialist (rheumatologist or nephrologist) per FDA labeling.

Definitions and Drug Information

BACKGROUND — canakinumab (Ilaris) overview

Drug class and mechanismCanakinumab is a recombinant human monoclonal antibody that neutralizes IL-1β by blocking its interaction with IL-1 receptors

Indications overviewIndicated for several rare autoinflammatory syndromes and inflammatory diseases including CAPS, TRAPS, HIDS/MKD, FMF, AOSD/SJIA, and symptomatic gout flares in adults when first-line therapies are not appropriate

Policy linkageThis policy ties coverage to specialist involvement, FDA-labeled dosing, documented clinical response for continuation, and prior authorization durations

Clinical diagnostic categories referenced in the policy

Listed diagnostic categoriesCAPS (FCAS, MWS), TRAPS, HIDS/MKD, FMF, AOSD/SJIA, and acute gout flares

Specialist diagnosis requirement