[A19-89] Asfotase alfa (hypophosphatasia) - Benefit assessment according to §35a Social Code Book V

Last updated 15.01.2020

Project no.:

Commission awarded on 15.10.2019 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Commission completed

Drug Assessment

Application field:
Digestion, metabolism and hormones


Long-term enzyme replacement therapy in paediatric-onset hypophosphatasia to treat the bone manifestations of the disease

Result of dossier assessment:

Infants with disease onset before the age of 6 months: hint of non-quantifiable added benefit; other patient groups: added benefit not proven


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.

Federal Joint Committee (G-BA)

2020-04-02 A G-BA decision was published.

G-BA documents on this decision


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