Evolocumab (3) (Repatha®) – Primary hypercholesterolaemia or mixed dyslipidaemia, ≥ 10 to < 18 years of age
Characteristics
| Start date | 01.01.2022 |
|---|---|
| Resolution | 16.06.2022 |
| INN | Evolocumab |
| Brand name | Repatha® |
| Pharm. company | Amgen GmbH |
| G-BA procedure ID | 2022-01-01-D-758 |
| Therapeutic area | Metabolic diseases |
| Reason for procedure | New Indication |
| Indication (German) |
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Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients aged 10 years and over with heterozygous familial hypercholesterolaemia, 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 |
|---|---|---|
| a1) | Children and adolescents with heterozygous familial hypercholesterolaemia aged 10-17 years who have not exhausted dietary and drug options for lipid lowering. | Maximum tolerated drug therapy according to the doctor's instructions, taking into account statins, cholesterol resorption inhibitors and anion exchangers. |
| a2) | Children and adolescents with heterozygous familial hypercholesterolaemia aged between 10 to 17 years of age, in whom dietary and drug options for lipid lowering have been have been exhausted | LDL apheresis (as "ultima ratio" in cases of refractory courses of therapy), if necessary with accompanying lipid-lowering therapy with medication. |
| b1) | Children and adolescents with homozygous familial hypercholesterolaemia aged 10-11 years who have not exhausted dietary and drug options for lipid lowering. | Maximum tolerated drug therapy according to the doctor's instructions, taking into account statins, cholesterol resorption inhibitors and anion exchangers. |
| b2) | Children and adolescents with homozygous familial hypercholesterolaemia aged 10-11 years who have exhausted dietary and drug options for lipid lowering. | LDL apheresis (as "ultima ratio" for therapy-refractory courses), if necessary with concomitant lipid-lowering drug therapy |
9. Associated procedures
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