[A21-171] Evolocumab (hypercholesterolaemia) - Benefit assessment according to §35a Social Code Book V
Last updated 01.04.2022
Project no.:
A21-171
Commission:
Commission awarded on 22.12.2021 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Digestion, metabolism and hormones
In children and adolescents with heterozygous familial hypercholesterolaemia (HeFH) aged 10 to 17 years, as an adjunct to diet, and possibly in combination with other lipid-lowering therapies, as well as in children with homozygous familial hypercholesterolaemia (HoFH) aged 10 to 11 years in combination with other lipid-lowering therapies
- Children and adolescents with HeFH aged 10 to 17 years in whom dietary and drug options for lipid lowering have not been exhausted: added benefit not proven.
- Children and adolescents with HeFH aged 10 to 17 years in whom dietary and drug options for lipid lowering have been exhausted: added benefit not proven.
- Children with HoFH aged 10 to 11 years in whom dietary and drug options for lipid lowering have not been exhausted: added benefit not proven.
- Children with HoFH aged 10 to 11 years in whom dietary and drug options for lipid lowering have been exhausted: 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.
| Project no. | Title | Status |
|---|---|---|
| A15-38 | Evolocumab - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A18-19 | Evolocumab (primary hypercholesterolaemia or mixed dyslipidaemia) - Benefit assessment according to §35a Social Code Book V (new scientific findings) | Commission completed |