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ATMP

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ATMPs in Germany - Libmeldy®

29.08.2024
Quantifiable additional benefit without evidence from RCTs - HTA on Libmeldy demonstrates that a sibling analysis with dramatic effects can justify a considerable additional benefit...
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ATMPs in Germany - Obligation for routine practice data collection

22.08.2024
The obligation for routine practice data collection negatively impacts reimbursement and reimbursement price...
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ATMPs in Germany - Zolgensma®

15.08.2024
HTA for Zolgensma gives insights on the legal option of the German HTA body to oblige routine practice data collection and reassessment...
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ATMPs in Germany - Zynteglo®

08.08.2024
For the first time, the arbitration board was faced with the complex task to develop criteria for the monetary evaluation of the one-time therapy Zynteglo...
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ATMPs in Germany - Luxturna®

01.08.2024
First considerable additional benefit for an ATMP – the additional benefit for Luxturna is based on a pivotal RCT and supportive results from long-term single-arm extension studies...
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ATMPs in Germany - Kymriah®

25.07.2024
German HTA requirements for indirect comparisons based on single-arm studies can hardly be fulfilled – repeated HTAs for Kymriah resulted in the same rating,...
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ATMPs in Germany - ATMP Quality Assurance Guideline

18.07.2024
The ATMP Quality Assurance Guideline restricts the reimbursement of several ATMPs, e. g. CAR-T cell therapies,....
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ATMPs in Germany - Orphan Drug Reassessment

11.07.2024
For ATMPs being orphan drugs keep in mind the risk of reassessment – challenges and learnings from the orphan drug reassessment of Yescarta...
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ATMPs in Germany - Yescarta®

04.07.2024
The German HTAs on Yescarta and Kymriah (first CAR-T cell therapies in the EU) touch many HTA regulations...
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ATMPs in Germany - Alofisel®

01.07.2024
Alofisel was the first ATMP with a broad rebate contract coverage and a generally agreed option to negotiate P4P-contract...
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ATMPs in Germany - Zalmoxis®

20.06.2024
HTA on Zalmoxis demonstrates several major assessment principles of the German HTA body....
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ATMPs in Germany - Spherox®

13.06.2024
Spherox is currently the only ATMP of the ACI procedures with a valid, centralized, EU marketing authorization...

 

Ansprechpartner

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Dr. Florentin Köhnemann
Tel. +49 (40) 41 33 081-48