Aliskiren / Amlodipin (1) – Rasilamlo®
Essential hypertension, add-on therapy
Characteristics
| Start date | 15.05.2011 – Marketing authorisation: 14.04.2011 |
|---|---|
| Resolution | 03.05.2012 |
| INN | Aliskiren/Amlodipin |
| Brand name | Rasilamlo® |
| Pharm. company | Novartis Pharma GmbH |
| G-BA Procedure ID | D-007 |
| ATC code | C09XA53 Renin-inhibitors (C09XA) |
| DDD | 0.15 g O |
| Therapeutic area | Cardiovascular diseases Hypertension (Arterial hypertension / Essential hypertension) |
| Reason for procedure | Initial assessment |
| Regulatory status | authorisation withdrawn by manufacturer |
| Therapeutic indication of the resolution |
|---|
|
Rasilamlo is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Treatment of essential hypertension in adult patients whose blood pressure cannot be adequately controlled with aliskiren or amlodipine alone. | (Lisinopril or Ramipril or Enalapril) + (Amlodipine or Nitrendipine) |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
Patients with arterial hypertension who require combination therapy
- As the necessary proof 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]).
- The G-BA notes that, in the dossier submitted by the pharmaceutical manufacturer for the benefit assessment of aliskiren/amlodipine, the manufacturer has not demonstrated or substantiated, in a manner compliant with statutory and subordinate legal requirements, that aliskiren/ amlodipine offers additional benefit compared with the appropriate comparator therapy determined by the G-BA and communicated to the manufacturer during the consultation.
- The dossier is therefore to be regarded as incomplete in this respect.
- Appropriate comparator therapy
- The appropriate comparator therapy for the combination of active substances aliskiren/ amlodipine for the treatment of essential hypertension is the combination therapy comprising an angiotensin-converting enzyme inhibitor (lisinopril or ramipril or enalapril) and a dihydropyridine-type calcium channel blocker (amlodipine or nitrendipine).
Courtesy translation only, please refer to the German original.
Associated procedures
| Aliskiren / Amlodipin (1) | Rasilamlo® | Novartis Pharma GmbH | Essential hypertension, add-on therapy | 156,600–565,900 | 100% additional benefit not proven |
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