CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ilaris

Defines prior authorization, initial and renewal medical necessity criteria, dosing, authorization length, quantity limits, billing codes, covered ICD-10 diagnoses and safety/documentation requirements for canakinumab (Ilaris) across Medicaid, Commercial and Medicare members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIlaris

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review Date

Key ActionInitial coverage provided up to 6 months (special gout flare: 1 dose / 12 weeks). Approvals may be renewed for additional 6-month intervals; gout flare single-dose approval covers one dose with re-treatment criteria required for additional doses.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes.

MultipleCovered indications

150 mgCommon adult unit dose

J0638Billing code

Coverage Summary

Policy defines prior authorization, initial and renewal medical necessity criteria, dosing, authorization length, quantity limits, billing codes, covered ICD-10 diagnoses and safety/documentation requirements for canakinumab (Ilaris) across Medicaid, Commercial and Medicare members. Coverage stance: covered with criteria across Medicaid, Commercial and Medicare in the absence of an applicable NCD/LCD. Effective date: 01/01/2020; Last review: 05/21/2025.

Continuation / Renewal Criteria

Renewal Criteria

Coverage renewal requires ALL of the following:

ALL of the following

Patient continues to meet universal and relevant indication-specific criteria from Initial Approval (Section IV)
Absence of unacceptable toxicity from the drug (examples: severe hypersensitivity, serious infections including tuberculosis, macrophage activation syndrome [MAS])
Evidence of disease response (ONE of, indication-specific)
- CAPS: improvement in patient's symptoms from baseline AND improvement in serum inflammatory proteins (eg, CRP and/or SAA) from baseline
- TRAPS/HIDS/MKD/FM F: improvement in patient's symptoms from baseline AND improvement of serum CRP
- AOSD/SJIA: improvement in signs and symptoms compared to baseline such as tender/swollen joint counts, reduction of CRP, and/or improvement on disease activity scoring tool (eg, JADAS or ACR-Pedi 30 with at least 30% improvement from baseline in 3 of 6 variables)
- Gout flares: refer to Section IV for re-treatment criteria

Provider Actions & Billing Requirements

Prior Authorization

Prior authorization and duration

Initial coverage provided up to 6 months. For gout flare, coverage is provided for a single dose covering 12 weeks (one dose / 12 weeks). Approvals may be renewed for additional 6-month intervals. For gout re-treatment, additional doses will be covered only if re-treatment criteria/intervals are met (re-treatment interval: at least 12 weeks between doses).

Documentation Required

Baseline testing and documentation

Document baseline inflammatory markers (eg, C‑Reactive Protein [CRP] and/or Serum Amyloid A [SAA] where indicated), document relevant genetic testing results when required by indication (eg, NLRP3/CIAS1, TNFRSF1A, MVK, MEFV exon 10), and document prior therapy trials and failures (eg, colchicine, NSAIDs, systemic corticosteroids) as applicable.

Documentation Required

TB and vaccination precautions

Evaluate and document latent tuberculosis (TB) screening prior to initiating therapy and provide ongoing monitoring for TB during treatment. Ensure patient vaccination status is up to date prior to starting therapy and avoid administration with live vaccines.

Denial Risk

Concurrent biologic/targeted therapy exclusion

Claims may be denied or prior authorization withheld if the patient is receiving concurrent biologic therapy or targeted synthetic therapy listed in the Universal Criteria (eg, IL‑inhibitors, TNF‑inhibitors, integrin receptor antagonists, T‑cell costimulation modulators, or targeted synthetic agents such as tofacitinib, baricitinib, upadacitinib).

Billing Rule

Dose units / quantity limits

Billing should use HCPCS J0638 (Injection, canakinumab, 1 mg) with 1 billable unit = 1 mg. Adhere to indication-specific quantity limits: CAPS — 150 billable units every 8 weeks (56 days); Gout Flare — 150 billable units every 12 weeks (84 days) for a single dose (re-treatment only per criteria, with at least 12 weeks between doses); All other indications — 300 billable units every 4 weeks (28 days).

HCPCS: J0638 (Injection, canakinumab, 1 mg; 1 unit = 1 mg)

Applicable Codes

HCPCS (billing code)HCPCSCovered

J0638

Injection, canakinumab, 1 mg (1 billable unit = 1 mg)

NDC (product identifier)NDCCovered

00078-0734-xx

Ilaris 150 mg single-dose solution vial

Covered ICD-10 Diagnosis CodesICD-10Covered

M04.1	Periodic fever syndromes
M04.2	Cryopyrin-associated periodic syndromes
M04.9	Autoinflammatory syndrome, unspecified
M06.1	Adult-onset Still's disease
M08.00	Unspecified juvenile rheumatoid arthritis of unspecified site
M08.011	Unspecified juvenile rheumatoid arthritis, right shoulder
M08.012	Unspecified juvenile rheumatoid arthritis, left shoulder
M08.019	Unspecified juvenile rheumatoid arthritis, unspecified shoulder
M08.021	Unspecified juvenile rheumatoid arthritis, right elbow
M08.022	Unspecified juvenile rheumatoid arthritis, left elbow

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Clinical Evidence

Key sources informing this policy include the Ilaris package insert (Novartis; November 2024) and multiple randomized controlled trials and observational studies. Clinical trials and reviews cited demonstrate efficacy and safety of canakinumab in systemic juvenile idiopathic arthritis (SJIA), familial Mediterranean fever (FMF), cryopyrin-associated periodic syndromes (CAPS), and gout flares, with common adverse reactions being infections (eg, nasopharyngitis, URTI, UTI).

Background

This policy was established by the Neighborhood Health Plan of Rhode Island Pharmacy & Therapeutics (P&T) Committee to align coverage with FDA labeling and relevant clinical literature. The criteria were developed with input from network prescribers and pharmacists to ensure use consistent with FDA-approved indications and to minimize risk and support cost-effective options. The policy applies to Medicaid, Commercial and Medicare members, subject to any applicable National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs).

Policy thresholds

Gout flare re-treatment intervalAt least 12 weeks between doses for re-treatment

Gout flare prior flares requirement≥ 3 gout flares within the previous 12 months

TRAPS recurrent disease definition> 6 flares per year