UnitedHealthcare Ilaris coverage & Prior Auth

Coverage Criteria for Ilaris (canakinumab)

CAPS (FCAS, MWS) — Initial and Continuation Therapy

Covered when ALL of the following are met for CAPS (FCAS, MWS):

Initial therapy — diagnosis: Diagnosis of FCAS or MWS by, or in consultation with, a rheumatologist or immunologist with expertise

Initial therapy — dosing: Ilaris dosing for FCAS/MWS is in accordance with the United States Food and Drug Administration approved labeling

Initial therapy — authorization period: Initial authorization will be for no more than 12 months

Continuation therapy — current use: Patient is currently on Ilaris therapy for FCAS or MWS

Continuation therapy — dosing: Ilaris dosing for FCAS/MWS is in accordance with the United States Food and Drug Administration approved labeling

Continuation therapy — clinical response: Documentation of positive clinical response to Ilaris therapy

Continuation therapy — reauthorization period: Reauthorization will be for no more than 12 months

TRAPS — Initial and Continuation Therapy

Covered when ALL of the following are met for TRAPS:

Initial therapy — diagnosis: Diagnosis of TRAPS by, or in consultation with, a rheumatologist or immunologist with expertise in the diagnosis of TRAPS

Initial therapy — dosing: Ilaris dosing for TRAPS is in accordance with the United States Food and Drug Administration approved labeling

Initial therapy — authorization period: Initial authorization will be for no more than 12 months

Continuation therapy — current use: Patient is currently receiving Ilaris therapy for TRAPS

Continuation therapy — clinical response:

HIDS/MKD — Initial and Continuation Therapy

Covered when ALL of the following are met for HIDS/MKD:

Initial therapy — diagnosis: Diagnosis of HIDS or MKD by, or in consultation with, a rheumatologist or immunologist with expertise

Initial therapy — dosing: Ilaris dosing for HIDS/MKD is in accordance with the United States Food and Drug Administration approved labeling

Initial therapy — authorization period: Initial authorization will be for no more than 12 months

Continuation therapy — current use: Patient is currently receiving Ilaris for HIDS or MKD

Continuation therapy — clinical response:

Familial Mediterranean Fever (FMF) — Initial and Continuation Therapy

Covered when ALL of the following are met for Familial Mediterranean Fever (FMF):

Initial therapy — diagnosis: Diagnosis of FMF by, or in consultation with, a rheumatologist or immunologist with expertise in the diagnosis of FMF

Initial therapy — prior therapy: History of failure, contraindication, or intolerance to colchicine

Initial therapy — dosing: Ilaris dosing for FMF is in accordance with the United States Food and Drug Administration approved labeling

Initial therapy — authorization period: Initial authorization will be for no more than 12 months

Active Still's disease (AOSD, SJIA) — Initial and Continuation Therapy

Covered when ALL of the following are met for Active Still's disease (AOSD) and SJIA:

Initial therapy — diagnosis: Diagnosis of AOSD or SJIA by, or in consultation with, a rheumatologist or immunologist with expertise

Initial therapy — dosing: Ilaris dosing for AOSD/SJIA is in accordance with the United States Food and Drug Administration approved labeling

Initial therapy — no combination therapy: Patient is not receiving Ilaris in combination with a targeted immunomodulator (examples listed in policy)

Initial therapy — authorization period: Initial authorization will be for no more than 12 months

Gout flares — Single-dose authorization

Covered when ALL of the following are met for gout flares:

Diagnosis of a gout flare

Prior therapy: History of contraindication, intolerance, or treatment failure with both colchicine and a non-steroidal anti-inflammatory drug (NSAID)

Corticosteroid contraindication: Provider attests that the patient is not an appropriate candidate for systemic corticosteroids

Dosing and authorization period: Ilaris dosing is in accordance with United States FDA labeled dosing for gout flares; authorization will be issued for one dose for 12 weeks

Prescriber restriction:

Evidence-supported indications

Evidence-supported uses described in the document (trial inclusion/efficacy):

CAPS evidence: Canakinumab 150 mg subcutaneously induced complete responses in CAPS (Lachmann et al): 97% complete response in part 1; maintenance reduced flares versus placebo in withdrawal phase

Part 1: 34/35 complete response; placebo group had increased flares in withdrawal (P < 0.001).

FMF/HIDS/TRAPS evidence: Randomized trial across FMF, HIDS/MKD, and TRAPS cohorts showed higher responder rates and resolution of index flares with canakinumab 150 mg every 4 weeks versus placebo (primary outcome at week 16 favored canakinumab)

Median exposure ~113 days; infections were the most frequent adverse events.

SJIA evidence: Phase 3 trials in SJIA used canakinumab 4 mg/kg SC and demonstrated higher adapted JIA ACR30 responses at day 15 (84% vs 10%) and reduced risk of flare on continuation (74% vs 25% no flare), with glucocorticoid reductions documented

Trial 1 and withdrawal trial results summarized.

Ilaris (canakinumab) is not proven or medically necessary for the management or treatment of cardiovascular disease.

Clinical trial reports have noted a higher incidence of suspected infections among patients treated with canakinumab compared with placebo; examples in trials included increased suspected infections and, in some studies, serious infectious events.

When considering therapy with Ilaris, document known infection risks and monitor patients accordingly as infection rates were observed to be greater in the canakinumab arms of CAPS and SJIA/Still’s disease studies.

Within the excerpted sections of this policy, there are no explicit statements labeling other indications as ‘not medically necessary’; the document instead lists indications considered proven or medically necessary and provides criteria for coverage.

Billing and Coding

Applicable HCPCS CodesHCPCS

J0638

Injection, canakinumab, 1 mg

Applicable ICD-10 Codes (partial list shown in document)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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Applicable ICD-10 Diagnosis CodesICD-10

M08.269	Juvenile rheumatoid arthritis with systemic onset, unspecified knee
M08.271	Juvenile rheumatoid arthritis with systemic onset, right ankle and foot
M08.272	Juvenile rheumatoid arthritis with systemic onset, left ankle and foot
M08.279	Juvenile rheumatoid arthritis with systemic onset, unspecified ankle and foot
M08.28	Juvenile rheumatoid arthritis with systemic onset, vertebrae
M08.29	Juvenile rheumatoid arthritis with systemic onset, multiple sites
M08.2A	Juvenile rheumatoid arthritis with systemic onset, other specified site
M10.00	Idiopathic gout, unspecified site
M10.011	Idiopathic gout, right shoulder
M10.012	Idiopathic gout, left shoulder

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Gout flare frequency — enrollment criterion

Enrollment criterion>= 3 gout flares in the previous year

Documentation expectedClinical records should document frequency of flares and prior use/intolerance/contraindication to NSAIDs and colchicine

Authorization period for gout flare indicationOne dose authorized for 12 weeks

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization required. Providers must document diagnosis, specialist involvement (rheumatologist or immunologist when specified), prior therapy attempts, and reasons for discontinuation/intolerance/contraindication as applicable. Initial and reauthorization approvals are time-limited (generally up to 12 months) per indication.

Document diagnosis and that dosing is consistent with FDA‑approved labeling for the indication
For initial and continuation requests include documentation of positive clinical response for reauthorization purposes
Specialist involvement: diagnosis by or consultation with a rheumatologist or immunologist where indicated (e.g., TRAPS, FMF, HIDS/MKD)

Step Therapy

Step Therapy / Prior Medication Requirements

Step therapy applies for gout flares: canakinumab (Ilaris) is indicated only when patients have contraindication/intolerance or have failed recommended first‑line therapies. For FMF, documentation must show failure, contraindication, or intolerance to colchicine. Absent documentation of prior therapy attempts or reasons for not using them may lead to denial.

Key Definitions and Indications

Indications listed

CAPS (FCAS, MWS)Cryopyrin-Associated Periodic Syndromes including familial cold autoinflammatory syndrome and Muckle-Wells syndrome — covered when criteria met

TRAPSTumor necrosis factor receptor-associated periodic syndrome — covered when criteria met

HIDS/MKDHyperimmunoglobulin D syndrome / Mevalonate kinase deficiency — covered when criteria met

Familial Mediterranean Fever (FMF)Covered when history of failure/contraindication/intolerance to colchicine and other criteria met

Active Still's disease (AOSD/SJIA)Adult-onset Still's disease and systemic juvenile idiopathic arthritis — covered when criteria met

Gout flaresAcute gout flares — single-dose authorization when prior therapy and documentation criteria met

Background on Ilaris (canakinumab)

Ilaris (canakinumab) is a recombinant human monoclonal antibody that selectively targets interleukin‑1β (IL‑1β). It is indicated and addressed in this policy for multiple autoinflammatory and inflammatory conditions including Cryopyrin‑Associated Periodic Syndromes (CAPS; FCAS and MWS), TRAPS, HIDS/MKD, Familial Mediterranean Fever (FMF), Active Still’s disease (AOSD and SJIA), and acute gout flares.

For the listed indications, coverage in this policy ties medical necessity to a confirmed diagnosis (often by or in consultation with a rheumatologist or immunologist), adherence to FDA‑approved dosing, and indication‑specific prior therapy or authorization requirements as described in the criteria sets.

Policy Revision History

2024-12-01policy_effective

Policy became effective; coverage rationale and indications for Ilaris (canakinumab) established with criteria and authorization periods (initial and reauthorization up to 12 months; gout: one dose for 12 weeks).

2024-12-01coverage_criteria_revision

Revised coverage criteria for Active Still's disease/SJIA to specify that patients must not receive Ilaris in combination with a targeted immunomodulator (expanded example list).

2025-07-01template_updateLatest

OpenPayer

Ilaris (canakinumab) — Coverage Criteria

Coverage Criteria for Ilaris (canakinumab)

Billing and Coding

Provider Requirements and Authorization Rules

Key Definitions and Indications

Background on Ilaris (canakinumab)

Policy Revision History