WHA
 

Ilaris (canakinumab injection)

Indications for Prior Authorization

Ilaris (canakinumab injection)
  • For diagnosis of Periodic Fever Syndromes: Cryopyrin-Associated Periodic Syndromes (CAPS), Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), Familial Mediterranean Fever (FMF)
    Indicated for the treatment of the following autoinflammatory Periodic Fever Syndromes: Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS); Tumor Necrosis Factor Receptor (TNF) Associated Periodic Syndrome (TRAPS) in adult and pediatric patients; Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients; Familial Mediterranean Fever (FMF) in adult and pediatric patients.

  • For diagnosis of Systemic Juvenile Idiopathic Arthritis (SJIA)
    Indicated for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.

  • For diagnosis of Still’s disease (Adult-Onset Still’s Disease [AOSD])
    Indicated for the treatment of active Still’s disease, including Adult-Onset Still’s Disease (AOSD) in patients aged 2 years and older.

  • For diagnosis of Gout Flares
    Indicated for the symptomatic treatment of adult patients with gout flares in whom nonsteroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate.

Criteria

Ilaris

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Periodic Fever Syndromes (Cryopyrin-Associated Periodic Syndromes [CAPS], Tumor Necrosis Factor Receptor Associated Periodic Syndrome [TRAPS], Hyperimmunoglobulin D Syndrome [HIDS]/Mevalonate Kinase Deficiency [MKD], Familial Mediterranean Fever [FMF])

  • Diagnosis of one of the following periodic fever syndromes [A, B, 5, 6]:
    • cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS)
    • tumor necrosis factor (TNF) receptor associated periodic syndrome (TRAPS)
    • hyperimmunoglobulin D (Hyper-IgD) syndrome (HIDS)/mevalonate kinase deficiency (MKD)
    • familial mediterranean fever (FMF)
    AND
  • Prescribed by or in consultation with one of the following [C]:
    • Immunologist
    • Allergist
    • Dermatologist
    • Rheumatologist
    • Neurologist
    • Specialist with expertise in the treatment of periodic fever syndromes (e.g., gastroenterologist)
Ilaris

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Periodic Fever Syndrome (CAPS, TRAPS, HIDS/MKD, FMF)

  • Patient demonstrates positive clinical response to therapy [D]
Ilaris

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Systemic Juvenile Idiopathic Arthritis (SJIA)

  • Diagnosis of active systemic juvenile idiopathic arthritis (SJIA)
    • AND
  • Trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [1, 2]:
    • Minimum duration of a 3-month trial and failure of methotrexate
    • Minimum duration of a 1-month trial of a nonsteroidal anti-inflammatory drug (NSAID) (e.g., ibuprofen, naproxen)
    • Minimum duration of a 2-week trial of a systemic glucocorticoid (e.g., prednisone)
    AND
  • Prescribed by or in consultation with a rheumatologist
Ilaris

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Systemic Juvenile Idiopathic Arthritis (SJIA)

  • Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 2]:
    • Reduction in the total active (swollen and tender) joint count from baseline
    • Improvement in clinical features or symptoms (e.g., pain, fever, inflammation, rash, lymphadenopathy, serositis) from baseline
Ilaris

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Still's Disease

  • Diagnosis of Still’s Disease, including Adult-Onset Still’s Disease (AOSD)
    • AND
  • Trial and failure, contraindication, or intolerance to one of the following [1-3]:
    • Corticosteroids (e.g., prednisone)
    • Methotrexate
    • Nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen)
    AND
  • Prescribed by or in consultation with a rheumatologist
Ilaris

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Still's Disease

  • Patient demonstrates positive clinical response to therapy
Ilaris

Prior Authorization

Length of Approval: 12 Week(s)
For diagnosis of Gout Flares

  • Diagnosis of gout flares
    • AND
  • Trial and failure, contraindication, or intolerance to ALL of the following [1, 4]:
    • Nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen)
    • Colchicine
    • Corticosteroids (e.g., prednisone)
    AND
  • At least 12 weeks have or will have elapsed since the last Ilaris treatment [E]
    • AND
  • Prescribed by or in consultation with one of the following:
    • Rheumatologist
    • Nephrologist

  • Guideline ID
    GL-666202

  • Formulary
    Premium

  • Effective date
    Oct 1, 2026

  • P&T approval date
    Nov 17, 2009

P & T Revisions

2026-07-31, 2025-12-18, 2025-12-18, 2025-08-06, 2024-08-08, 2023-11-05, 2023-11-02, 2023-08-01, 2022-10-23, 2022-08-03, 2021-07-16, 2021-05-19, 2020-08-06, 2019-07-27

  1. Ilaris Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. November 2024.
  2. Onel KB, Horton DB, Lovell DJ, et al. 2021 American College of Rheumatology guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for oligoarthritis, temporomandibular joint arthritis, and systemic juvenile idiopathic arthritis. Arthritis Rheumatol. 2022;74(4):553-569.
  3. Mimura T, Kondo Y, Ohta A et al. Evidence-based clinical practice guideline for adult Still’s disease. Mod Rheumatol. 2018;28(5):736-757.
  4. FitzGerald JD, Dalbeth N, Mikuls T, et al. 2020 American College of Rheumatology guideline for the management of gout. Arthritis Care Res. 2020;72(6):744-760.
  5. Romano M, Arici ZS, Piskin D, et al. The 2021 EULAR/American College of Rheumatology points to consider for diagnosis, management and monitoring of the interleukin- 1 mediated autoinflammatory diseases: cryopyrin- associated periodic syndromes, tumour necrosis factor receptor-associated periodic syndrome, mevalonate kinase deficiency, and deficiency of the interleukin-1 receptor antagonist. Ann Rheum Dis. 2022 Jul; 81(7):907-921.
  6. Gattorno M, Hofer M, Federici S, et al. Classification criteria for autoinflammatory recurrent fevers.
  7. Ozen S, Sag E, Oton T, et al. EULAR/PReS endorsed recommendations for the management of familial Mediterranean fever (FMF): 2024 update. Ann Rheum Dis. 2025 Jun; 84(6):899-909.
  8. Chetrit EB, Pisetsky DS, Case SM. Familial Mediterranean fever: Clinical manifestations and diagnosis. Wolters Kluwer. Updated June 2026. Available at https://www.uptodate.com. Accessed July 23, 2026.
  9. Ozen S, Demirkaya E, Erer B, et al. EULAR recommendations for the management of familial Mediterranean fever. Ann Rheum Dis. 2016 Apr; 75(4):644-651.
  1. The combination of genetic mutation analysis results and presence of disease-specific clinical features of periodic fever syndromes are critical in differentiating these conditions from clinically complex differential diagnoses that present with overlapping inflammatory manifestations (e.g., SJIA, AOSD, other autoimmune disorders). [5, 6]
  2. A confirmatory genotype of FMF is considered for patients with pathogenic/likely pathogenic mutations as homozygotes or compound heterozygotes. Non-confirmatory genotype refers to carriers of a single pathogenic mutation or two MEFV variants, one of which is non-pathogenic, although a small percentage of patients with non-confirmatory genotypes have manifested with FMF disease. [6, 8]
  3. Most patients with CAPS, TRAPS, and MKD are managed by pediatricians and pediatrician specialists, then care is transitioned to rheumatologists once patients reach adulthood. Specialists involved with the management of IL-1 mediated SAIDs include, but are not limited to, immunologists, ophthalmologists, otolaryngologists, nephrologists, and neurologists. Most patients with FMF experience their first attack in early childhood FMF is treated by different experienced specialists, including clinical geneticists, pediatric/adult rheumatologists, internists, nephrologists, and gastroenterologists. [5, 8, 9]
  4. The goal of periodic fever syndrome treatment is to achieve minimal clinical signs and symptoms and control laboratory biomarkers of systemic inflammation to prevent associated downstream organ damage. [5, 7]
  5. The recommended dose of Ilaris for adult patients with a gout flare is 150 mg administered subcutaneously. In patients who require re-treatment, there should be an interval of at least 12 weeks before a new dose of Ilaris may be administered [1].
  • 2026-07-31: Annual Review 2026 - Removed criterion that Ilaris is not used in combination with other TNF inhibitors or IL-1 inhibitors throughout criteria buckets. Added "specialist with expertise in the treatment of periodic fever syndromes (e.g., gastroenterologist)" as additional prescriber option for periodic fever syndrome indication. Revised 12 week interval allowance criterion for gout indication. Background updates.
  • 2025-12-18: No criteria change, bulk copy oRX-EHB
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2025-08-06: 2025 Annual Review - no changes
  • 2024-08-08: 2024 Annual Review - no changes
  • 2023-11-05: 12/1/23: Addition of criteria for the new gout flares indication. 1/1/24: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-11-02: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-08-01: 2023 UM Annual Review. Removal of "Other medical specialist" requirement. Removed Ilaris 180mg as it is discontinued.
  • 2022-10-23: Further clinical detail added for SJIA
  • 2022-08-03: 2022 Annual Review - No changes to criteria
  • 2021-07-16: 2021 UM Annual Review.
  • 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
  • 2020-08-06: 2020 UM Annual review and new criteria for indication of Still's Disease, including Adult-Onset Still's Disease.
  • 2019-07-27: Annual review with minor change to list examples of NSAIDs for PJIA indication per NCQA audit results. Background sections updated. JM 7/15/2019