Bempedoinsäure (1) – Nilemdo®
Primary hypercholesterolaemia or mixed dyslipidaemia
Characteristics
| Start date | 01.11.2020 – Marketing authorisation: 01.04.2020 |
|---|---|
| Resolution | 15.04.2021 |
| INN | Bempedoinsäure |
| Brand name | Nilemdo® |
| Pharm. company | Daiichi Sankyo Deutschland GmbH |
| G-BA Procedure ID | D-601 |
| ATC code | C10AX15 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 | 0.18 g O |
| Therapeutic area | Metabolic diseases Dyslipidemia, Hypercholesterolemia |
| Reason for procedure | Initial assessment |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
|---|
|
Nilemdo 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 - 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 drug and dietary options for lipid lowering have not been exhausted. | Maximum tolerated drug therapy as determined by the physician, 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 drug (except evolocumab) and dietary options for lipid lowering. | Evolocumab* or LDL apheresis (as "ultima ratio" in case of refractory courses of therapy), if necessary with concomitant 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) |
2 (CLEAR HARMONY, CLEAR WISDOM) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT (off-label) |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Patient eligibility |
a) or mixed dyslipidaemia, where pharmacological and dietary options for lowering lipid levels have not been fully utilised
- The additional benefit is not proven.
- In summary, the stable background therapy administered in the studies particularly given the high cardiovascular risk among the included patients with inadequately controlled LCL-C levels, does not appear appropriate for a fair comparison of bempedoic acid against the appropriate comparator therapy.
- mortality
- Further endpoints in both studies included mortality, cardiovascular events and, in the CLEAR WISDOM AE study,
- morbidity
- In the CLEAR WISDOM trial, the primary endpoint was the change in LDL-C levels at week 12.
- Additional endpoints in both studies included mortality, cardiovascular events and, in the CLEAR WISDOM study, AE.
- Side effects
- In the CLEAR HARMONY study, safety endpoints were assessed as the primary endpoint, including, for example, adverse events (AEs) and clinical safety laboratory parameters, amongst others.
b) or mixed dyslipidaemia, in which pharmacological (excluding evolocumab) and dietary options for lipid-lowering have been exhausted
- The additional benefit is not proven.
- No data were presented for the assessment of the additional benefit of bempedoic acid for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet, compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Bempedoinsäure (1) | Nilemdo® | Daiichi Sankyo Deutschland GmbH | Primary hypercholesterolaemia or mixed dyslipidaemia | 284,750–286,750 | 100% additional benefit not proven |
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