Product Details

Ilaris

Canakinumab
150 mg/Vial
Powder for Solution for Subcutaneous Injection
Single-Use 6-mL Glass Vial (Preservative-Free)

DIN/PIN/NPN

02344939

Manufacturer

Novartis Pharma Canada Inc.

Formulary Listing Date

2012-03-19  

Unit Price

106.6667

Amount MOH Pays

106.6667

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AC08

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Metabolic/Genetic Modifiers

Canakinumab

  • Brand(s): Ilaris
  • Dosage Form/Strength: 150 mg/vial injection

Muckle-Wells Syndrome:

The patient has a diagnosis of Muckle-Wells Syndrome (MWS) based on meeting each of the following confirmatory results:

  1. Clinical diagnosis of MWS; 

  1. NLRP3 mutation (mutational analysis required); 

  1. SAA levels ≥ 10 mg/L; and 

  1. Assessment score of patient’s disease activity determined by the following 4 parameters: skin disease, arthralgia, conjunctivitis, and fatigue/malaise ≥ mild, moderate, or severe. 

If a patient is without NLRP3 mutation, a request will be considered on a case-by-case basis if the other confirmatory criteria are met and if the exclusion criteria are not met. However, the initial approval would be for 6 months; if the patient demonstrated a sustained SAA level below 10 mg/L, a renewal of funding for a 1-year approval period would be considered.

Initial Approval Period: 1 year

NOMID Syndrome:

The patient has a Diagnosis of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) based on meeting each of the following confirmatory results:

  1. Clinical diagnosis of NOMID. 

  1. Presentation of symptoms of NOMID made in a patient below 6 months of age. 

  1. NLRP3 mutation (mutational analysis required). 

  1. A score of patient’s disease activity determined by the following 4 parameters: skin disease, arthralgia, conjunctivitis, and fatigue/malaise ≥ mild, moderate, or severe.

If a patient is without NLRP3 mutation, a request will be considered on a case-by-case basis if the other confirmatory criteria are met and if the exclusion criteria are not met. However, the initial approval would be for 6 months; if the patient demonstrated a sustained SAA level below 10 mg/L, a renewal of funding for a 1-year approval period would be considered.

Initial Approval Period: 6 months

For Both Indications 

For all patients, the treatment is supervised by medical specialists with knowledge in the management of CAPS (Cryopyrin-Associated Periodic Syndromes).

The approved dosage will be:

  • Bodyweight > 40 kg: 150 mg subcutaneously every 8 weeks 

  • Bodyweight = 15 kg – 40 kg: 2 mg/kg subcutaneously every 8 weeks.
    (For children 15 kg – 40 kg with an inadequate response, the dose can be increased to 3 mg/kg.)

For all patients, funding requests will be denied if any of the exclusion criteria is met: 

  1. The patient is bedridden where any physical activity brings on discomfort and symptoms which occur at rest AND not amenable to surgical/medical intervention; 

  1. The patient has another life-threatening disease where prognosis is unlikely to be influenced by Ilaris® (canakinumab) therapy (e.g. neuroblastoma, leukemia etc.);

  1. The patient has a life-expectancy of six months or less, regardless of the cause; or

  1. The patient has Familial Cold Auto-Inflammatory Syndrome (FCAS).

Renewal Criteria:

Confirmation from the Patient’s physician that the patient has benefited or continues to benefit from therapy with Ilaris, is expected to continue to do so and that each of the following is met:

  1. The patient has SAA levels below 10 mg/L. If SAA levels 10 mg/L or higher over a 6-month interval and that is sustained over two consecutive 6-month intervals, approval for funding may be withdrawn.

  1. An assessment score of patient’s skin disease, arthralgia, conjunctivitis, and fatigue/malaise shows no or minimal disease activity.

  1. The patient:
    a) is not bedridden where any physical activity brings on discomfort and symptoms which occur at rest AND not amenable to surgical/medical intervention;
    b) has no other life-threatening disease where prognosis is unlikely to be influenced by Ilaris® (canakinumab) therapy (e.g., neuroblastoma, leukemia etc.);
    OR
    c) has not developed a life-threatening complication or a severe injection reaction to Ilaris® (canakinumab) not treatable by other therapeutic measures.

  2. The patient has adhered with prescribed injection schedule for optimal management of the disease

  3. The patient has adhered to all safety and effectiveness monitoring of the treatment

  4. Treatment will be supervised by medical specialists with knowledge in the management of CAPS

The approved dosage for Subsequent Approvals is the same as Initial Approvals.

EAP Drug Request Form:

Ilaris (canakinumab) Drug Request Form

Product Monograph

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