Drug manufacturer deviates from the appropriate comparator therapy specified by the G-BA
The fixed drug combination of aliskiren and amlodipine (trade name: Rasilamlo-) was approved in April 2011 for the treatment of people with hypertension in whom aliskiren or amlodipine alone has an insufficient effect. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this drug combination offers an added benefit compared with the present standard drug therapy in people with essential hypertension. However, such an added benefit cannot be inferred from the dossier, as the drug manufacturer deviated from the specifications of the Federal Joint Committee (G-BA) and chose a different comparator therapy.
Calcium channel blocker and ACE inhibitor specified as comparator therapy
Aliskiren interferes with the production of blood-pressure controlling hormones (the renin-angiotensin-aldosterone system). Amlodipine is a calcium channel blocker that reduces calcium uptake in the smooth muscle cells of the arterial blood vessels. This expands the vessels and hence reduces blood pressure. In the new fixed combination both drugs are contained in a single pill.
The G-BA has specified the drug combination of a calcium channel blocker (amlodipine or nitrendipine) and an ACE inhibitor (lisinopril, ramipril or enalapril) as the appropriate comparator therapy. ACE inhibitors also interfere with the renin-angiotensin-aldosterone system.
Drug manufacturer compared fixed combination with free combination
In its dossier the pharmaceutical company compared the fixed combination with the free combination of the two drugs and thus deviated from the G-BA's specifications. From IQWiG's point of view the company did not sufficiently justify this deviation. Neither did it submit studies that would have been relevant to an assessment of the fixed combination of aliskiren and amlodipine versus the appropriate comparator therapy specified by the G-BA. Therefore no proof of an added benefit can be inferred from the assessment presented in the manufacturer dossier.
G-BA decides on the extent of added benefit
The procedure for inferring the overall conclusion on the extent of added benefit is a proposal from IQWiG. The G-BA, which has opened a formal commenting procedure, decides on the extent of added benefit.
The website gesundheitsinformation.de, which is issued by IQWiG, provides easily understandable brief information (German version).
The G-BA website contains both general information on benefit assessments pursuant to -35a Social Code Book V and specific information on the assessment of the fixed combination of aliskiren and amlodipine (German version).