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Canadian Drug Review Reimbursement Decision

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Generic Canakinumab
Company Novartis Pharmaceuticals Canada Inc.
Indication Cryopyrin-Associated Periodic Syndromes (CAPS)
Condition Endocrine, nutritional and metabolic diseases
Submission Type
Patient Population CAPS is a heterogeneous group of extremely rare autosomal-dominant, autoinflammatory diseases. Canakinumab is a human interleukin (IL)-1 beta monoclonal antibody that Health Canada approved for the ongoing management of CAPS in adults and children aged four years and older, including: FCAS or familial cold urticaria (FCU), and MWS. Canakinumab may also be used in NOMID or chronic infantile neurological, cutaneous, articular (CINCA) syndrome. Clinical data to support the use of canakinumab in patients with the NOMID phenotype are very limited. The recommended dose of canakinumab is 150 mg for patients with body weight greater than 40 kg and 2 mg/kg for patients with body weight between 15 kg and 40 kg. For children 15 kg to 40 kg, with an inadequate response, the dose may be increased to 3 mg/kg. Canakinumab is administered every eight weeks as a subcutaneous injection. If a satisfactory clinical response (resolution of rash and other generalized inflammatory symptoms) has not been achieved seven days after treatment, a second dose of 150 mg or 2 mg/kg may be considered. The drug is available as single-use vials containing 150 mg of canakinumab.
Status Complete
Date of Recommendation 2011-01-26
Recommendation Summary Do not list
Recommendation Details The Canadian Expert Drug Advisory Committee (CEDAC) recommends that canakinumab not be listed.
Reason for Recommendation Reasons for the Recommendation: 1. One 24-week double-blind randomized controlled trial (RCT) in 31 patients with Muckle- Wells Syndrome (MWS) reported statistically significantly less episodes of disease flare in patients treated with canakinumab compared with placebo; however, there were no statistically significant between-treatment differences in patient global assessment of symptoms or quality of life. 2. None of the RCT or open-label studies reviewed by CEDAC provided evidence that canakinumab treatment reduces or reverses severe disease complications. Given the limited evidence available it is unclear if potential benefits exceed potential harms from this lifelong treatment. Of Note: 1. There are differing clinical opinions regarding the use of canakinumab in the treatment of flare versus continuous treatment; however, there are no RCTs comparing these different treatment approaches. 2. The definition of complete response in the clinical trials was not validated, and the Committee expressed concern regarding the absence of measures to evaluate partial as well as complete response. 3. As the majority of trial participants were diagnosed with MWS, there are limited data regarding effects of canakinumab in familial cold autoinflammatory syndrome (FCAS) or neonatal-onset multisystem inflammatory disease (NOMID). 4. Cryopyrin-associated periodic syndromes (CAPS) is a rare disease condition. Using conventional criteria, canakinumab has not been shown to be cost-effective, though costeffectiveness is only one factor that is used by drug plans in making funding decisions. It has been argued that the costs of drugs to treat rare diseases are often high because of the relatively small number of patients for whom the drug is indicated.
Clinical Report:
Pharmacoeconomic Report:
Final Recommendation Report: CDR clinical report  CADTH-CDR Final Recommendation report

†The information referenced on this page is compiled from publicly available documents published by CADTH and is available through the embedded links.

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