Reason for request

Inclusion on the list of medicines refundable by National Health Insurance (B/28) and approved for hospital use (B/28 and B/50).

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Clinical Benefit

Moderate

In dual therapy, in combination with a sulfonylurea :
the actual benefit of the proprietary medicinal product JANUVIA at a dose of 50 mg is moderate.

In dual therapy in combination with insulin :
the actual benefit of the proprietary medicinal products JANUVIA 25 mg and 50 mg is moderate.

Insufficient

In the indications in combination with metformin :
the Committee considers that the actual benefit of the proprietary medicinal product JANUVIA at dosages of 25 mg and 50 mg in their indications combination with metformin, in dual therapy and triple therapy, is insufficient to justify reimbursement by National Health Insurance.

Low

In monotherapy :
the actual benefit of the proprietary medicinal products JANUVIA 25 mg and 50 mg is low.


Clinical Added Value

no clinical added value

In view of the available data, the Transparency Committee considers that the proprietary medicinal products JANUVIA at dosages of 25 mg and 50 mg of sitagliptin, in monotherapy or in dual therapy in combination with a sulfonylurea or insulin, offer no improvement in actual benefit (IAB V) in the treatment of diabetic patients with renal impairment.


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See also