Alirocumab (3) – Praluent®
Hypercholesterolaemia, ≥ 8 years to 17 years
Characteristics
| Start date | 15.12.2023 – Marketing authorisation: 15.11.2023 |
|---|---|
| Resolution | 06.06.2024 |
| INN | Alirocumab |
| Brand name | Praluent® |
| Pharm. company | Sanofi-Aventis Deutschland GmbH |
| G-BA Procedure ID | D-1000 |
| ATC code | C10AX14 Other lipid modifying agents (C10AX) |
| ICD-10 codes (AIS) | E78.0Pure hypercholesterolemia, E78.2Mixed hyperlipidemia, E78.4Other hyperlipidemia, E78.5Hyperlipidemia, unspecified, E78.88, E78.9Disorder of lipoprotein metabolism, unspecified |
| Alpha-ID codes (AIS) | I16606Hyperlipidemia, I16611Hyperlipoproteinuria, I2449Mixed hyperlipidemia, I2459Familial hyperlipidemia, I64600Primary hypercholesterolemia, I94846Dyslipidemia |
| Therapeutic area | Metabolic diseases Hypercholesterolemia |
| Reason for procedure | New therapeutic indication |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
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|
Praluent is indicated, as an adjunct to diet, for the treatment of children and adolescents aged 8 to 17 years with heterozygous familial hypercholesterolemia (HeFH): – in combination with a statin or with a statin and other lipid-lowering therapies in patients who do not achieve target LDL-C levels with maximally tolerated statin therapy, or – as monotherapy or in combination with other lipid-lowering therapies in patients with statin intolerance or if statins are contraindicated. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Children and adolescents with heterozygous familial hypercholesterolemia aged 8 to 17 years for whom dietary and drug options for lipid lowering have not been exhausted | Maximum tolerated drug therapy as prescribed by the doctor, taking into account statins, cholesterol resorption inhibitors and anion exchangers |
| b) | Children and adolescents with heterozygous familial hypercholesterolemia aged 8 to 17 years for whom dietary and drug options for lipid reduction have been exhausted | Evolocumab (from the age of 10) or LDL apheresis (as a last resort for treatment-refractory courses), possibly with concomitant lipid-lowering drug therapy |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: no data submitted) |
- Clinical trials
- The randomised, controlled trial EFC14643 included children and adolescents aged between 8 and 17 years with heterozygous familial hypercholesterolaemia who, despite statin treatment with or without additional lipid-modifying therapy, or in cases of statin intolerance despite treatment with other (non-statin-based) lipid-modifying therapies.
a) Children and adolescents with heterozygous familial hypercholesterolaemia aged between 8 and 17 years, for whom dietary and pharmacological options for lowering lipids have not been fully utilised
- The additional benefit is not proven.
- The registration study EFC14643, which was presented by the pharmaceutical manufacturer only as supplementary evidence, is not suitable for the present benefit assessment of alirocumab for patient group a), as there was no scope within the study to adjust lipid-modifying therapy and the appropriate comparator therapy was therefore not implemented.
b) children and adolescents with heterozygous familial hypercholesterolaemia aged between 8 and 17 years, in whom dietary and pharmacological options for lowering lipid levels have been exhausted
- An additional benefit is not proven.
- The EFC14643 registration trial, which was presented by the pharmaceutical manufacturer only as supplementary evidence, is not suitable for the present benefit assessment of alirocumab for patient group b), as evolocumab and LDL apheresis were not administered in the study and the appropriate comparator therapy was therefore not implemented.
Courtesy translation only, please refer to the German original.
Associated procedures
| Alirocumab (3) | Praluent® | Sanofi-Aventis Deutschland GmbH | Hypercholesterolaemia, ≥ 8 years to 17 years | 958–1,178 | 100% additional benefit not proven | |
| Alirocumab (2) | Praluent® | Sanofi-Aventis Deutschland GmbH | Hypercholesterolemia or mixed dyslipidaemia | 271,750 | 100% additional benefit not proven | |
| Alirocumab (1) | Praluent® | Sanofi-Aventis Deutschland GmbH | Hypercholesterolemia or mixed dyslipidaemia |
1,500
273,250 |
100% additional benefit not proven repealed subpopulations |
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