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Canadian Drug Review Reimbursement Decision

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  Zenhale (inhalation aerosol)
Generic Mometasone furoate / formoterol fumarate
Company Merck Canada Inc.
Indication asthma
Condition Respiratory
Submission Type
Patient Population Zenhale is a fixed-dose combination of an inhaled corticosteroid (mometasone furoate) and a long-acting beta-agonist (LABA) (formoterol fumarate dihydrate) that has a Health Canada indication for the maintenance treatment of asthma in adults and children 12 years of age and older with reversible obstructive airway disease whose asthma cannot be adequately controlled on asthma controller medications. It is available as a 120-dose inhaler providing pressurized metered dose suspension for inhalation in the following dose combinations of mometasone and formoterol, respectively, per actuation: 50/5 mcg, 100/5 mcg, and 200/5 mcg. The Health Canada-recommended dose is two inhalations twice daily (morning and evening) by oral inhalation. The maximum daily recommended dose is 800/20 mcg (given as two inhalations of mometasone/formoterol 200/5 mcg twice daily) for patients 12 years of age and older.
Status Complete
Date of Recommendation 2011-09-28
Recommendation Summary Do not list
Recommendation Details The Canadian Expert Drug Advisory Committee (CEDAC) recommends that mometasone furoate/formoterol fumarate dihydrate (Zenhale) not be listed.
Reason for Recommendation 1. The Committee considered the comparative clinical benefit of mometasone/ formoteral to be uncertain. The only RCT designed to compare the efficacy of mometasone/ formoterol with fluticasone/ salmeterol in asthma (study 4705) was limited by its early termination at 12 weeks, open-label design, and a non-inferiority margin for the primary outcome that was of uncertain clinical relevance. 2. There are no RCTs in patients with asthma that compare the effectiveness and safety of Zenhale with a single-ingredient corticosteroid inhaler that is marketed in Canada.
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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