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)

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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