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Canakinumab (Ilaris®)
Utilization Management Policy
Version Date: June 2021

Restricted Product(s):

canakinumab (Ilaris®) subcutaneous injection for administration by healthcare professional

FDA Approved Use:

  • For treatment of autoinflammatory Periodic Fever Syndromes:
    • Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older, including:
      • Familial Cold Auto-inflammatory Syndrome (FCAS)
      • 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 treatment of Active Still’s disease, including Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients 2 years of age and older
  • For the symptomatic treatment of gout flares in adults in whom non-steroidal 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 for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

  1. The patient has a diagnosis of Cryopyrin-Associated Periodic Syndrome (CAPS), including Familial Cold Auto-Inflammatory Syndrome (FCAS) or Muckle-Wells Syndrome (MWS); AND 
    1. The patient is 4 years of age or older; OR 
  2. The patient has a diagnosis of Tumor Necrosis Factor (TNF) Receptor-Associated Periodic Syndrome (TRAPS); OR 
  3. The patient has a diagnosis of Hyperimmunoglobulin D Syndrome (HIDS); OR 
  4. The patient has a diagnosis of Mevalonate Kinase Deficiency (MKD); OR
  5. The patient has a diagnosis of Familial Mediterranean Fever (FMF); AND 
    1. The patient has tried and had an inadequate response with colchicine for at least 6 months [medical record documentation required]; OR 
    2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to colchicine [medical record documentation required]; OR 
  6. The patient has a diagnosis of active systemic juvenile idiopathic arthritis (SJIA); AND 
    1. The patient is 2 years of age or older; AND 
    2. The patient has documented active systemic features (e.g., ongoing fever for at least 2 weeks, evanescent erythematous rash, generalized lymphadenopathy, ≥1 joint with active arthritis, hepatomegaly, splenomegaly, serositis); AND 
    3. ONE of the following: 
      1. The patient has tried and had an inadequate response to TWO of the following drug classes used in the treatment of SJIA [medical record documentation required]:  
        • DMARDs (i.e., methotrexate, leflunomide) for at least a 3-month trial  
        • Systemic corticosteroids (oral or intravenous) for at least a 3- month trial  
        • NSAIDs (e.g., ibuprofen, celecoxib) for at least a 1-month trial; OR 
      2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the drug classes listed above (i.e., DMARDs, systemic corticosteroids, NSAIDs) [medical record documentation required]; OR  
  7. The patient has a diagnosis of adult onset Still’s disease (AOSD); AND 
    1. The patient has tried and had an inadequate response to at least ONE corticosteroid [medical record documentation required]; OR 
    2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL corticosteroids [medical record documentation required]; AND 
    3. The patient has tried and had an inadequate response to methotrexate [medical record documentation required]; OR 
    4. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to methotrexate [medical record documentation required]; AND 
  8. The patient has a diagnosis of gout flares; AND 
    1. The patient is 18 years of age or older; AND
    2. The patient has experienced greater than or equal to 3 flares in the past 12 months [medical record documentation required]; AND
    3. The patient has ONE of the following [medical record documentation required]: 
      1. The patient has tried and had an inadequate response to ONE non-steroidal anti-inflammatory drug (NSAID) OR 
      2. The patient has an intolerance or hypersensitivity to ONE non-steroidal anti-inflammatory drug (NSAID) OR 
      3. The patient has an FDA labeled contraindication to ALL non-steroidal anti-inflammatory drugs (NSAIDs); AND 
    4. The patient has ONE of the following [medical record documentation required]: 
      1. The patient has tried and had an inadequate response to colchicine OR 
      2. The patient has an intolerance or hypersensitivity to colchicine OR 
      3. The patient has an FDA labeled contraindication to colchicine; AND 
    5. Repeated courses of corticosteroids are not appropriate for the patient [medical record documentation required]; AND 
  9. The patient will NOT be receiving canakinumab in combination with another biologic immunomodulator agent; AND  
  10. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, pediatrician, rheumatologist) or has consulted with a specialist in the area of the patient’s diagnosis; AND 
  11. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
  12. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)* 

Duration of Approval: Gout flares: 84 days (12 weeks); All other indications: 365 days (1 year)

 

Continuation Criteria for Approval: 

  1. The patient was approved through Blue Cross NC initial criteria for approval; OR 
  2. The patient would have met initial criteria for approval at the time they started therapy; AND 
  3. The patient will NOT be receiving canakinumab in combination with another biologic immunomodulator agent; AND 
  4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, pediatrician, rheumatologist) or has consulted with a specialist in the area of the patient’s diagnosis; AND
  5. The patient continues to have a clinical benefit with canakinumab (Ilaris®) therapy; AND 
  6. In patients who require re-treatment for gout flares, there must be an interval of at least 12 weeks before a new dose of ILARIS may be administered; AND
  7. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND
  8. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

Duration of Approval: Gout Flares: 84 days (12 weeks); All other indications: 365 days (1 year)
FDA Label Reference
MedicationIndication  DosingHCPCSMaximum Units*
canakinumab (Ilaris®)   subcutaneous (SC) injectionCAPS Body weight >40 kg: 150 mg SC every 8 weeks  Body weight ≥15 kg and ≤40 kg: 2 mg/kg SC every 8 weeks; may be increased to 3 mg/kg for those with inadequate response J0638900
TRAPS, HIDS/MKD, and FMF Body weight ≤40 kg: 2 mg/kg SC every 4 weeks; may be increased to 4 mg/kg if the clinical response is not adequate  Body weight >40 kg: 150 mg SC every 4 weeks; may be increased to 300 mg every 4 weeks if the clinical response is not adequate  1950
Still’s disease (AOSD and SJIA) 4 mg/kg (maximum 300 mg) for patients with a body weight ≥7.5 kg SC every 4 weeks 1950
Gout flares 150 mg 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. 150

*Maximum units allowed for duration of approval

*Site of Care Medical Necessity Criteria

  1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR
  2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met: 
    1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR 
    2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR 
    3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR
    4. Re-initiation of therapy, defined as ONE of the following:
      1. First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR
      2. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR
    5. Requirement of a change in the requested restricted product formulation; AND
  3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional. 

References:

all information referenced is from FDA package insert unless otherwise noted below.

  1. Ringold S, Weiss PF, Beukelman T, et al. 2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis. American College of Rheumatology. October 2013. Arthritis & Rheumatism. 65(10):2499-2512. 

Policy Implementation/Update Information:

March 2024: Criteria change: Added new indication for Gout flares under FDA Approved Uses, added associated criteria, and updated FDA Label Reference Table. Removed the Non-Discrimination and Accessibility Notice.

October 2021: Criteria change: Added Site of Care medical necessity criteria. Policy notification given 8/2/2021 for effective date 10/1/2021.

June 2021: Criteria change: Medical record documentation required for trial and failure of conventional agents; removed criterion point regarding medication history indicating use of another biologic immunomodulator agent for the treatment of SJIA; minor updates to language and formatting for clarity.

June 2021: Criteria change: Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.

*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy. 
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