Aliskiren / Amlodipin (1) – Rasilamlo®

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.