Dossier assessment
Tafamidis (wild-type or hereditary transthyretin amyloid cardiomyopathy) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V
Report documents
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Dossier assessment
Tafamidis (wild-type or hereditary transthyretin amyloid cardiomyopathy) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V
Project details
- Project no.
- G20-03
- Commission
- Commission awarded on 24.02.2020 by the Federal Joint Committee (GBA).
- Report type
- Dossier assessment
- Status
- Commission completed
- Department/Division
- Health Economics
- Topic
- Heart and circulation
- Note
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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 Tafamidis 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.
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Tafamidis (transthyretin amyloidosis) - Benefit assessment according to §35a Social Code Book V
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Status: Commission completed