[A12-11] Linagliptin - Re-assessment of benefit according to § 35a, Para. 5b, Social Code Book V (dossier assessment)
Last updated 03.12.2012
Commission awarded on 03.09.2012 by the Federal Joint Committee (G-BA).
Digestion, metabolism and hormones
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.