Inclisiran (1) – Leqvio®
Primary hypercholesterolaemia or mixed dyslipidaemia
Characteristics
| Start date | 01.02.2021 – Marketing authorisation: 09.12.2020 |
|---|---|
| Resolution | 15.07.2021 |
| INN | Inclisiran |
| Brand name | Leqvio® |
| Pharm. company | Novartis Pharma GmbH |
| G-BA Procedure ID | D-640 |
| ATC code | C10AX16 Other lipid modifying agents (C10AX) |
| DDD | 1.6 mg P |
| Therapeutic area | Metabolic diseases |
| Reason for procedure | Initial assessment |
Studies and Results
a) Adults with primary hypercholesterolaemia (heterozygous, familial and non-familial) or mixed dyslipidaemia, in whom dietary and pharmacological options for lowering lipid levels have not been fully utilised
- An additional benefit is not proven.
- No data were submitted for comparison with the appropriate comparator therapy to assess the additional benefit of inclisiran for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet. Consequently, the additional benefit is not proven.
b) Adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, in whom dietary and pharmacological options for lowering lipids (other than evolocumab or alirocumab) have been exhausted
- An additional benefit is not proven.
- No data were submitted for comparison with the appropriate comparator therapy to assess the additional benefit of inclisiran for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet. The additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Inclisiran (2) | Leqvio® | Novartis Pharma GmbH | Primary hypercholesterolaemia, aged ≥ 12 years to < 18 years | n.d. | active procedure | |
| Inclisiran (1) | Leqvio® | Novartis Pharma GmbH | Primary hypercholesterolaemia or mixed dyslipidaemia | 284,750–410,900 | 100% additional benefit not proven |
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