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 XELEVIA at a dose of 50 mg is moderate.

Low

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

Insufficient

In the indications in combination with metfomin
the actual benefit of the proprietary medicinal products XELEVIA at dosages of 25 mg and 50 mg in their indications in combination with metformin, in dual therapy and triple therapy, is insufficient to justify reimbursement by National Health insurance.


Clinical Added Value

no clinical added value

In view of the available data, the Transparency Committee considers that the proprietary medicinal products XELEVIA 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