Bempedoinsäure / Ezetimib (1) – Nustendi®
Primary hypercholesterolaemia or mixed dyslipidaemia
Characteristics
| Start date | 01.11.2020 – Marketing authorisation: 27.03.2020 |
|---|---|
| Resolution | 15.04.2021 |
| INN | Bempedoinsäure/Ezetimib |
| Brand name | Nustendi® |
| Pharm. company | Daiichi Sankyo Deutschland GmbH |
| G-BA Procedure ID | D-602 |
| ATC code | C10BA10 Combinations of various lipid modifying agents (C10BA) |
| 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 O |
| Therapeutic area | Metabolic diseases Dyslipidemia, Hypercholesterolemia |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Nustendi 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 in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe - alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone, - in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin. |
| 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) |
1 (1002FDC-053) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
| Reason for dividing into subpopulations (G-BA) | Patient eligibility |
- Clinical trials
- In the four-arm, double-blind, randomised, controlled trial 1002FDC-053, the fixed-dose combination of bempedoic acid andezetimibe was compared with the individual substances bempedoic acid and ezetimibe, as well as with placebo, over a treatment period of 12 weeks.
a) or mixed dyslipidaemia, in whom pharmacological and dietary options for lipid-lowering have not been exhausted
- The additional benefit is not proven.
- In summary, the study submitted as supplementary evidence by the pharmaceutical manufacturer is not suitable for evaluating a comparison of the fixed-dose combination of bempedoic acid and ezetimibe against the appropriate comparator therapy.
- On the one hand, the patients included do not adequately represent the authorised therapeutic indication as set out in the SmPC.
- On the other hand, the appropriate comparator therapy was not implemented and the treatment duration of 12 weeks is too short for an assessment.
b) or mixed dyslipidaemia, in whom pharmacological (other than evolocumab) and dietary options for lipid-lowering 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 the fixed-dose combination of bempedoic acid and ezetimibe for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet.
Courtesy translation only, please refer to the German original.
Associated procedures
| Bempedoinsäure / Ezetimib (1) | Nustendi® | Daiichi Sankyo Deutschland GmbH | Primary hypercholesterolaemia or mixed dyslipidaemia | 284,750–286,750 | 100% additional benefit not proven |
<< List of all resolutions