Lomitapid (1) – Lojuxta®
Hypercholesterolemia
Characteristics
| Start date | 15.12.2013 – Marketing authorisation: 31.07.2013 |
|---|---|
| Resolution | 05.06.2014 |
| Limitation date | 15.06.2015 |
| INN | Lomitapid |
| Brand name | Lojuxta® |
| Pharm. company | Aegerion Pharmaceuticals GmbH |
| G-BA Procedure ID | D-093 |
| ATC code | C10AX12 Other lipid modifying agents (C10AX) |
| DDD | 40 mg O |
| Therapeutic area | Metabolic diseases |
| Reason for procedure |
Initial assessment
Reassessed in: Lomitapid (2) (27.11.2015) |
| Regulatory status | Exceptional Circumstances |
Studies and Results
a) Patients for whom pharmacological and dietary options for lowering lipid levels have been exhausted
- As the necessary proof has not been provided in full, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code [SGB V]).
b) Patients for whom pharmacological and dietary options for lowering lipids have not been exhausted
- As the necessary evidence has not been submitted in full, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code (SGB V)).
Courtesy translation only, please refer to the German original.
Associated procedures
| Lomitapid (2) | Lojuxta® | Aegerion Pharmaceuticals GmbH | Hypercholesterolemia | 60–69 | 100% additional benefit not proven | |
| Lomitapid (1) | Lojuxta® | Aegerion Pharmaceuticals GmbH | Hypercholesterolemia |
0
61–71 |
100% additional benefit not proven repealed |
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