[G21-16] Atidarsagene autotemcel/OTL-200 (metachromatic leukodystrophy) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V

Last updated 02.08.2021

Project no.:

Commission awarded on 03.05.2021 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Commission completed

Health Economics

Application field:
Digestion, metabolism and hormones


In accordance with §35a (1) Sentence 11 Social Code Book (SGB) V, the added medical benefit of orphan drugs is deemed as proven by the fact that they have been approved. On behalf of the Federal Joint Committee (G-BA), IQWiG therefore solely assesses the information on patient numbers and costs in the pharmaceutical company's dossier.

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. The resolution on the extent of added benefit is passed by the G-BA after the hearing. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA Website.


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