Empagliflozin (EMPA)/metformin (MET) fixed-dose combination (FDC) tablet (Synjardy) is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus (T2DM) inadequately controlled on MET alone, MET and a sulfonylurea (SU), MET and pioglitazone (PIO), or MET and insulin; or when EMPA and MET are already being co-administered as separate tablets with or without an SU, PIO, or insulin. The manufacturer is seeking reimbursement for adult patients with T2DM who are already stabilized on therapy with MET and EMPA, to replace the individual components.
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| Drug | Empagliflozin and Metformin Fixed-Dose Combination (Synjardy) |
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| Indication | SYNJARDY (empagliflozin and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus inadequately controlled on:
metformin sulfonylurea in combination with metformin pioglitazone in combination with metformin insulin in combination with metformin
Or in patients already being treated and achieving glycemic control with:
metformin and empagliflozin as separate tablets sulfonylurea in combination with metformin and empagliflozin as separate tablets pioglitazone in combination with metformin and empagliflozin as separate tablets insulin in combination with metformin and empagliflozin as separate tablets
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| Reimbursement request | As an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus already stabilized on therapy with metformin and empagliflozin, to replace the individual components of metformin and empagliflozin in these patients. |
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| Dosage form | 5 mg / 500 mg, 5 mg / 850 mg, 5 mg /1,000 mg, 12.5 mg / 500 mg, 12.5 mg / 850 mg, 12.5 mg / 1,000 mg, tablets for oral administration |
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| NOC Date | July 29, 2016 |
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| Manufacturer | Boehringer Ingelheim (Canada) Ltd. |
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Empagliflozin/metformin FDC (Synjardy) Common Drug Review Pharmacoeconomic Report was prepared using information from Delta PA from IMS Health Canada Inc. The analyses, conclusions, opinions and statements expressed are those of the Canadian Agency for Drugs and Technologies in Health and not those of IMS Health Canada Inc.
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