Reason for request

JANUVIA: 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, JANUVIA 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 an add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control". JANUMET: Inclusion on the list of medicines refundable by National Health Insurance (B/56) and approved for hospital use (B/56 and B/50) in the following extensions of indication: “JANUMET is indicated as an adjunct to diet and exercise to improve glycaemic control in type 2 diabetic patients as an add-on to insulin (triple therapy) when stable doses of insulin and metformin alone do not provide adequate glycaemic control”.

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Clinical Benefit

Substantial

The actual benefit of JANUVIA and JANUMET is substantial 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, JANUVIA and JANUMET do not provide an improvement in actual benefit (IAB V) in the management of these type 2 diabetic patients.


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