[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

Topic:
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.

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