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Canadian Drug Review Reimbursement Decision

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Generic velaglucerase alfa
Company Shire Human Genetic Therapies
Indication Gaucher disease
Condition Endocrine, nutritional and metabolic diseases
Submission Type
Patient Population Velaglucerase alfa has a Health Canada indication as a long-term enzyme replacement therapy for pediatric and adult patients with GD1. It is available as a sterile lyophilized powder in single- use vials of 400 U per vial. The Health Canada-approved dose is 60 U/kg administered every other week as a 60-minute intravenous (IV) infusion.
Status Complete
Date of Recommendation 2011-04-25
Recommendation Summary List with criteria/condition
Recommendation Details The Canadian Expert Drug Advisory Committee (CEDAC) recommends that velaglucerase alfa be listed for patients with type 1 Gaucher Disease (GD1) in jurisdictions that provide funding for imiglucerase, when it is cost saving to do so.
Reason for Recommendation 1. In one small (N = 35) double-blind randomized controlled trial (RCT) of patients with GD1, velaglucerase alfa was reported to be non-inferior to imiglucerase, based on improvements in mean hemoglobin concentration. 2. Velaglucerase alfa is less costly compared with imiglucerase (subject to dose and patient weight). Of Note: 1. On a per unit (U) basis, velaglucerase alfa ($4.89/U) is less costly than imiglucerase ($6.15/U). However, given the potential for drug wastage and the availability of 200 U and 400 U vials of imiglucerase (compared with only 400 U vials of velaglucerase alfa), for some dose and weight combinations, imiglucerase may be less costly (e.g., pediatric patients who weigh less than 10 kg and who require doses of 45 U/kg to 60 U/kg). 2. The Committee noted that velaglucerase alfa is not an alternative for those patients in whom imiglucerase does not provide sufficient benefit.
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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