IQWiG: Indication of an Added Benefit of Cariprazine
The Institute for Quality and Efficiency in Health Care (IQWiG) last Monday, July 16, 2018, published its opinion on cariprazine as part of its „benefit assessment“ (see also my posts from October 1st, 2017 and May 5th, 2018). The authority concludes that there is an “indication” that cariprazine has a “non-quantifiable added benefit” in the group of patients with schizophrenia with predominant negative symptoms compared to an „appropriate comparator therapy“.
The report (in German) is available here. The Federal Joint Committee (G-BA) had selected second-generation antipsychotics (amisulpride or aripiprazole or olanzapine or paliperidone or quetiapine or risperidone or ziprasidone) as appropriate comparator therapies. In the acute treatment of schizophrenia in adults, the “added benefit is not proven” according tot he IQWiG. Also for other patients of the target population, that is those without predominant negative symptoms, the added benefit is not proven. Details on the drug you can find here.
The evaluation represents a small milestone. Cariprazine is the first psychotropic drug since the introduction of the Act on the Reform of the Market for Medicinal Products (AMNOG), to which the IQWiG at least grants an indication of added value compared to the available therapies. This is certainly due to the study published in the Lancet in 2017 (Nemeth et al., Lancet 2017), which showed that cariprazine in patients with predominant negative symptoms has significantly better efficacy than risperidone, which was the comparator in that study (see my post from October 1st, 2017). This is a good signal for psychopharmacology, because it shows that there is indeed progress when the industry conducts the right studies.
The process has not yet been completed, because it is not the IQWiG that decides on the added benefit, but the G-BA. On August 21, an oral hearing will take place at the G-BA in Berlin, where the manufacturer and experts, as well as patients and their representatives, will be able to comment on their previously stated written comments.
A brief explanation and summary of the results, which is understandable also to laymen, can be found on the website of the IQWiG, but only in German language.