[A21-13] Inclisiran (primary hypercholesterolaemia or mixed dyslipidaemia) - Benefit assessment according to §35a Social Code Book V

Last updated 03.05.2021

Project no.:
A21-13

Commission:
Commission awarded on 01.02.2021 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Digestion, metabolism and hormones

Indication:

Adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia

Result of dossier assessment:

Patients in whom dietary and drug options for lipid lowering have not been exhausted: added benefit not proven. Patients in whom dietary and drug options for lipid lowering (except evolocumab) have been exhausted: 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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