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Canadian Drug Review Reimbursement Decision

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Generic Ticagrelor
Company AstraZeneca Canada Inc.
Indication acute coronary syndrome
Condition Cardiovascular
Submission Type Initial
Patient Population Ticagrelor, co-administered with acetylsalicylic acid (ASA), has a Health Canada indication for secondary prevention of atherothrombotic events in patients with ACS (unstable angina [UA], non-ST elevation myocardial infarction [NSTEMI], or ST elevation myocardial infarction [STEMI]) who are to be managed medically and those who are to be managed with percutaneous coronary intervention (PCI) (with or without stent) and/or coronary artery bypass graft (CABG). Ticagrelor is a selective and reversibly bound antagonist of the adenosine diphosphate P2Y12 receptor. It is available as 90 mg oral tablets. Health Canada recommends that ticagrelor be initiated with a single 180 mg loading dose and then continued at 90 mg twice daily. Ticagrelor should be used with a daily maintenance dose of ASA of 75 mg to 150 mg.
Status Complete
Date of Recommendation 2011-12-16
Recommendation Summary Do not list
Recommendation Details The Canadian Drug Expert Committee (CDEC) recommends that ticagrelor not be listed at the submitted price.
Reason for Recommendation The pre-specified subgroup analysis (by region), in the one large randomized controlled trial (RCT) of patients with acute coronary syndromes (ACS), did not provide evidence of the superiority of ticagrelor compared with clopidogrel in a North American patient population to support a higher price for ticagrelor. 2. Given the limitations identified with the manufacturer’s pharmacoeconomic submission, the Committee noted that the cost-effectiveness of ticagrelor could not be properly assessed. 3. The daily cost of ticagrelor ($2.96) is greater than clopidogrel ($2.58). Of Note: Based on a review of the clinical evidence, the Committee felt that a reduced price would increase the likelihood of a recommendation to "list" or "list with criteria".
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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