Tisagenlecleucel (B-cell acute lymphoblastic leukaemia) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V

Report documents

1. Dossier assessment

   Tisagenlecleucel (B-cell acute lymphoblastic leukaemia) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V

   published on

   17.12.2018

   Document type

   PDF-Dokument, 137 kB, DE, PDF

   Download file : Dossier assessment (PDF-Dokument, 137 kB, DE, PDF)

Project details

Project no.

G18-11

Commission

Commission awarded on 14.09.2018 by the Federal Joint Committee (GBA).

Report type

Dossier assessment

Status

Commission completed

Department/Division

Health Economics

Topic

Cancer

Note

In accordance with § 35a (para. 1, sentence 11) Social Code Book V, the added medical benefit of orphan drugs is deemed as proven by the fact that they have been approved. For the Tisagenlecleucel report commissioned by 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.

Connected Projects

1. Dossier assessment

   Tisagenlecleucel (diffuse large B-cell lymphoma) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V

   Project no.

   G18-10

   Last updated

   17.12.2018

   Status: Commission completed

2. Dossier assessment

   Tisagenlecleucel (B-cell acute lymphoblastic leukaemia) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V (expiry of the decision)

   Project no.

   G20-04

   Last updated

   01.07.2020

   Status: Commission completed

3. Dossier assessment

   Tisagenlecleucel (diffuse large B-cell lymphoma) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V (expiry of the decision)

   Project no.

   G20-05

   Last updated

   01.07.2020

   Status: Commission completed

4. Dossier assessment

   Tisagenlecleucel (ALL) – Assessment according to §35a (para. 1., sentence 11) Social Code Book V

   Project no.

   G23-22

   Last updated

   01.12.2023

   Status: Commission completed

5. Dossier assessment

   Tisagenlecleucel (diffuse large B-cell lymphoma) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V (expiry of the decision)

   Project no.

   G23-21

   Last updated

   01.12.2023

   Status: Commission completed

6. Dossier assessment

   Tisagenlecleucel (follicular lymphoma) - Assessment according to §35a (para. 1, sentence 11) Social Code Book V

   Project no.

   G22-23

   Last updated

   21.10.2022

   Status: Commission completed