[A12-11] Linagliptin - Re-assessment of benefit according to § 35a, Para. 5b, Social Code Book V (dossier assessment)

Last updated 03.12.2012

Project no.:
A12-11

Commission:
Commission awarded on 03.09.2012 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Digestion, metabolism and hormones

Note:

According to § 35a (5b) Social Code Book V, concerning decisions published up to 31 December, a pharmaceutical company may apply for a renewed benefit assessment at any time if the added benefit is considered to be "not proven" because the necessary evidence was not completely presented by the company. After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

03.12.2012

Linagliptin: Once again, no proof of added benefit

Even from the new dossier, no added benefit can be derived/No suitable studies submitted

Accompanying information

Further information for consumers and patients is provided on IQWiG's health information website www.informedhealth.org.

Federal Joint Committee (G-BA)

2012-02-21 A G-BA decision was published.

G-BA documents on this decision (German only)

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