Finally: A New Psychotropic Drug in Germany – Cariprazine
In my blog post on October 1st, 2017, I prophesied that the launch of the antipsychotic drug cariprazine will be significantly delayed in Germany because of the huge hurdle the German Act on the Reform of the Market for Medicinal Products (Arzneimittelmarkt-Neuordnungsgesetz, AMNOG) represents for a small company like Recordati for market access. I was wrong.
I will constantly update this information with new information about the compound, so check back once in a while.
What is the timeline for the assessment of cariprazine by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) and the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG)?
The drug was launched Mid-April, that means that the IQWiG has three months for its assessment. This assessment will be publicly available Mid-July. The public, especially patients, patient advocates, experts and professional societies like the German Association for Psychiatry, Psychotherapy and Psychosomatics (Deutsche Gesellschaft für Psychiatrie und Psychotherapie, Psychosomatik und Nervenheilkunde, DGPPN) will then have just three weeks for declaration of their opinion. The deadline is August 6th. The public hearing at the G-BA in Berlin will then take place in the second half of August. The G-BA will publicize the result of its assessment in the first half of October. Then we will know whether cariprazine offers an “additional benefit” at least according to the opinion of the IQWiG/G-BA.