Pharmacy Prior Authorization Criteria

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) or Muckle-Wells Syndrome (MWS); Tumor Necrosis Factor Receptor 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:
• 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:
• Immunologist
• Allergist
• Dermatologist
• Rheumatologist
• Neurologist
AND
• Both of the following:
• Patient is not receiving concomitant treatment with Tumor Necrosis Factor (TNF) inhibitors (e.g., Enbrel [etanercept], Humira [adalimumab], Remicade [infliximab])
• Patient is not receiving concomitant treatment with Interleukin-1 inhibitor (e.g., Arcalyst [rilonacept], Kineret [anakinra])

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
AND
• Both of the following:
• Patient is not receiving concomitant treatment with Tumor Necrosis Factor (TNF) inhibitors (e.g., Enbrel [etanercept], Humira [adalimumab], Remicade [infliximab])
• Patient is not receiving concomitant treatment with Interleukin-1 inhibitor (e.g., Arcalyst [rilonacept], Kineret [anakinra])

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
• Both of the following:
• Patient is not receiving concomitant treatment with Tumor Necrosis Factor (TNF) inhibitors (e.g., Enbrel [etanercept], Humira [adalimumab], Remicade [infliximab])
• Patient is not receiving concomitant treatment with Interleukin-1 inhibitor (e.g., Arcalyst [rilonacept], Kineret [anakinra])
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
AND
• Both of the following:
• Patient is not receiving concomitant treatment with Tumor Necrosis Factor (TNF) inhibitors (e.g., Enbrel [etanercept], Humira [adalimumab], Remicade [infliximab])
• Patient is not receiving concomitant treatment with Interleukin-1 inhibitor (e.g., Arcalyst [rilonacept], Kineret [anakinra])

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
• Both of the following:
• Patient is not receiving concomitant treatment with Tumor Necrosis Factor (TNF) inhibitors (e.g., Enbrel [etanercept], Humira [adalimumab], Remicade [infliximab])
• Patient is not receiving concomitant treatment with Interleukin-1 inhibitor (e.g., Arcalyst [rilonacept], Kineret [anakinra])
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
AND
• Both of the following:
• Patient is not receiving concomitant treatment with Tumor Necrosis Factor (TNF) inhibitors (e.g., Enbrel [etanercept], Humira [adalimumab], Remicade [infliximab])
• Patient is not receiving concomitant treatment with Interleukin-1 inhibitor (e.g., Arcalyst [rilonacept], Kineret [anakinra])

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, 6]:
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen)
• Colchicine
• Corticosteroids (e.g., prednisone)
AND
• Patient has not received Ilaris in the last 12 weeks [A]
AND
• Prescribed by or in consultation with one of the following:
• Rheumatologist
• Nephrologist

P & T Revisions

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

References

1. Ilaris Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. August 2023.
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. Lachmann HJ, Kone-Paut I, Kuemmerle-Deschner JB, et al. Use of canakinumab in the cryopyrin-associated periodic syndrome. N Engl J Med. 2009;360(23):2416-25.
5. Aksentijevich I, Putnam CD, Remmers EF, et al. Clinical continuum of cryopyrinopathies: novel CIAS1 mutations in North-American patients and a new cryopyrin model. Arthritis Rheum. 2007;56(4):1273-85.
6. 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.

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Revision History

• 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

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