[A22-11] Burosumab (X-linked hypophosphataemia) - Benefit assessment according to §35a Social Code Book V
Last updated 02.05.2022
Project no.:
A22-11
Commission:
Commission awarded on 01.03.2022 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Children's and adolescents' health
Indication:
Treatment of X-linked hypophosphataemia (XLH) in patients aged 1 to 17 years with radiographic evidence of bone disease
Result of dossier assessment:
- Children aged 1 to 12 years with an RSS total score ≥ 2.0: added benefit not proven.
- Children aged 1 to 12 years with an RSS total score < 2.0: added benefit not proven.
- Adolescents aged 13 to 17 years: added benefit not proven.
Note:
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.
| Project no. | Title | Status |
|---|---|---|
| G18-05 | Burosumab (X-linked hypophosphataemia) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V | Commission completed |
| G19-15 | Burosumab (X-linked hypophosphataemia) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V (expiry of the decision) | Commission completed |
| G20-27 | Burosumab (X-linked hypophosphataemia) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V | Commission completed |
| A22-12 | Burosumab (X-linked hypophosphataemia, = 18 years) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A22-88 | Burosumab (FGF23-related hypophosphataemia) - Benefit assessment according to §35a Social Code Book V | Commission completed |