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) |
| ICD-10 codes (AIS) | E78.0Pure hypercholesterolemia, E78.2Mixed hyperlipidemia, E78.4Other hyperlipidemia, E78.5Hyperlipidemia, unspecified, E78.8Other disorders of lipoprotein metabolism, E78.9Disorder of lipoprotein metabolism, unspecified |
| Alpha-ID codes (AIS) | I16606Hyperlipidemia, I16611Hyperlipoproteinuria, I2449Mixed hyperlipidemia, I2459Familial hyperlipidemia, I64600Primary hypercholesterolemia, I94846Dyslipidemia |
| DDD | 1.6 mg P |
| Therapeutic area | Metabolic diseases Dyslipidemia, Hypercholesterolemia |
| Reason for procedure | Initial assessment |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
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Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: - in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
|
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in whom dietary and drug options for lipid lowering have not been exhausted. | Maximum tolerated drug therapy according to the doctor's instructions, taking into account statins, cholesterol resorption inhibitors and anion exchangers. |
| b) | Adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia who have exhausted dietary and drug options for lipid lowering (other than evolocumab or alirocumab). | Evolocumab* or Alirocumab* or LDL apheresis (as "ultima ratio" in case of refractory courses of therapy), if necessary with accompanying medicinal lipid-lowering therapy. * The requirements regarding the prescription restrictions of the Medicinal Products Guideline (AM-RL) Annex III must be observed. |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted |
| Reason for dividing into subpopulations (G-BA) | Previous treatment |
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 (1) | Leqvio® | Novartis Pharma GmbH | Primary hypercholesterolaemia or mixed dyslipidaemia | 284,750–410,900 | 100% additional benefit not proven |
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