Reason for request
XELEVIA: Inclusion on the list of medicines refundable by National Health Insurance (B/28) and approved for hospital use (B/28 and B/50) in the following extensions of indication: “For patients with type 2 diabetes mellitus, XELEVIA is indicated to improve glycaemic control: as monotherapy, in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance and as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control”. VELMETIA: Inclusion on the list of medicines refundable by National Health Insurance and approved for hospital use (B/56) in the following extension of indication: “VELMETIA is indicated as an adjunct to diet and exercise to improve glycaemic control in type 2 diabetic patients as add-on to insulin (triple therapy) when stable dose of insulin and metformin alone do not provide adequate glycaemic control”.
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Clinical Benefit
Substantial |
The actual medical benefit of XELEVIA and VELMETIA is high in triple therapy in combination with insulin and metformin. |
Clinical Added Value
no clinical added value |
As triple therapy, in combination with stable doses of insulin and metformin in patients who have not achieved adequate glycaemic control, XELEVIA and VELMETIA do not provide an improvement in actual benefit (IAB V) in the management of these type 2 diabetic patients. |
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