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Canadian Drug Review Reimbursement Decision

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Generic Prasugrel hydrochloride
Company Eli Lilly Canada Inc.
Indication acute coronary syndrome
Condition Cardiovascular
Submission Type
Patient Population Prasugrel is indicated by Health Canada for co-administration with ASA, for the early and long-term secondary prevention of atherothrombotic events in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: • Unstable angina, or non-ST-elevation myocardial infarction (UA/NSTEMI), managed with PCI • ST-elevation myocardial infarction (STEMI) managed with primary or delayed PCI. Prasugrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of adenosine diphosphate receptors on platelets. It is available as a 10 mg, unscored, film-coated tablet. Health Canada recommends that prasugrel be initiated with a single 60 mg loading dose and then continued at a 10 mg once-daily dose for long-term treatment. Patients taking prasugrel should also take ASA (75 mg to 325 mg) daily.
Status Complete
Date of Recommendation 2011-02-16
Recommendation Summary Do not list
Recommendation Details The Canadian Expert Drug Advisory Committee (CEDAC) recommends that prasugrel not be listed.
Reason for Recommendation The Committee considered the comparative efficacy of prasugrel and clopidogrel to be uncertain due to the design of the TRITON-TIMI 38 study, but noted that the proportion of patients having a major bleeding event in the TRITON-TIMI 38 study was statistically significantly greater for prasugrel compared with clopidogrel. Of Note: 1. The Committee considered that prasugrel may be of some benefit for patients in whom stent thrombosis has occurred while receiving clopidogrel and acetylsalicylic acid (ASA); however, there were no direct data to support such a recommendation. 2. The Committee expressed concern regarding the potential for an increased frequency of malignancy with prasugrel compared with clopidogrel and discussed the need for analyses of prospectively collected malignancy data. At the request of regulatory authorities, cancer data will be prospectively collected and analyzed as part of the ongoing TRILOGY-ACS study.
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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