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Canadian Drug Review Reimbursement Decision

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Generic Telmisartan / Amlodipine
Company Boehringer Ingelheim (Canada) Ltd.
Indication hypertension
Condition Cardiovascular
Submission Type
Patient Population Telmisartan/amlodipine FDC has a Health Canada indication for treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate. Telmisartan is an angiotensin II receptor blocker and amlodipine is a calcium channel blocker. Telmisartan/amlodipine FDC is not indicated for initial therapy. It is available as oral tablets in the following dose combinations of telmisartan/amlodipine: 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg, and 80 mg/10 mg. Health Canada recommends that patients should be titrated on the individual components. Patients receiving telmisartan and amlodipine from separate tablets can instead receive telmisartan/amlodipine FDC containing the same component doses in one tablet once daily.
Status Complete
Date of Recommendation 2011-12-16
Recommendation Summary List
Recommendation Details The Canadian Drug Expert Committee (CDEC) recommends that Twynsta, which is a combination of telmisartan and amlodipine, be listed.
Reason for Recommendation 1. Telmisartan/amlodipine FDC, at both the lowest and highest recommended doses, was demonstrated to be bioequivalent to the same doses of its individual components given separately. 2. At the submitted price, the cost of telmisartan/amlodipine FDC ($0.68 daily) is less than telmisartan ($1.13 daily) plus amlodipine ($0.34 to $0.50 daily) given separately Of Note: The Committee gave consideration to the provision in the Health Canada product monograph which states that telmisartan/amlodipine FDC is not indicated for initial therapy, and that patients should be titrated on the individual components.
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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