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Linagliptin: Once again, no proof of added benefit
Date:1/30/2013

Linagliptin (trade name Trajenta) has been approved since August 2011 to improve blood glucose control in adults with type 2 diabetes. The assessment of the new dossier according to the German Act on the Reform of the Market for Medicinal Products (AMNOG) again showed that no added benefit of the drug over the appropriate comparator therapy (ACT) can be determined, because the pharmaceutical company has not submitted any relevant studies. This is the conclusion of the report by the German Institute for Quality and Efficiency in Health Care (IQWiG) published on 3rd December 2012.

First assessment negative because the comparator therapy deviated from the one specified

In its first early benefit assessment dated January 2012, IQWiG was unable to determine any added benefit because the pharmaceutical company (Boehringer Ingelheim) had chosen sitagliptin as comparator therapy in its first dossier instead of the ACT (a sulfonylurea) specified by the Federal Joint Committee (G-BA). A decision based on the IQWiG report was made by the G-BA on 29th March 2012.

Company can submit a new dossier in the transitional period

On the basis of an exemption clause since enshrined in the German Social Code Book V (35a Paragraph 5b), during a transitional period up to the end of 2012, companies are allowed to apply for a new assessment at any time if the added benefit is considered unproven due to incomplete evidence. The G-BA decided to allow a corresponding application for linagliptin and commissioned IQWiG to assess the new dossier submitted by the company. Linagliptin is the first drug to be re-assessed according to this rule.

Approval status distinguishes between three treatment situations

The ACT (the sulfonylureas glibenclamide and glimepiride) specified by the G-BA differs according to which of three treatment situations applies: firstly, where linagliptin is given alone (monotherapy) as a substitut
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Contact: Anna-Sabine Ernst
presse@iqwig.de
49-221-356-850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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