Benefit assessment of antidiabetics

All gliptins should be checked

06/08/2012

The Federal Joint Committee (GBA) has ordered a benefit assessment of all gliptins and thus extended this form of drug evaluation to the existing market for the first time. Manufacturers of antidiabetics are invited to submit the necessary dossiers by 31 December. Subsequently, the evaluation procedure will start in January 2013, according to the Joint Federal Committee's communication.

The fact that the benefit assessment planned since the entry into force of the German Medicines Market Reorganization Act (AMNOG) on 1 January 2011 will be extended for the first time to already existing medicinal products is due to a scandal involving the GBA decision on the active substance linagliptin. Here, the GBA had seen no added benefit based on the available documents, so that the health insurance companies would have only refunded the fixed amount for generics. Manufacturers were far too low on the prices that could be achieved and, in addition, an unfavorable signal effect was expected in other countries, so that the introduction of the drug for type 2 diabetes in the German market was abandoned. In order to achieve a fair assessment, the antidiabetics sitagliptin, vildagliptin and saxagliptin, which have already been approved for some time, as well as the drug combinations metformin / sitagliptin and metformin / vildagliptin should now be subjected to a corresponding benefit assessment.

Benefit assessment of gliptins required for competitive reasons
GBA Chairman Dr. Ing. Rainer Hess explained that, for competitive reasons, a benefit assessment of all gliptins - including those already on the market before the entry into force of AMNOG - had to be made. Otherwise, producers of older products would have an undue advantage over manufacturers of active substances of the same class of substances currently on the market. Because with the medicines, which were brought before the 1. January 2011 on the market, the price liberty of the manufacturers is not limited by the use-dependent reimbursement amount. What amount is set for the reimbursement, negotiates the Central Association of statutory health insurance (SHI) with the pharmaceutical manufacturers based on the benefit assessment of the active ingredients by the GBA.

Antidiabetics without added benefit?
In the case of linagliptin, the Federal Joint Committee assessed the benefit compared to generics therapy and could not find any added benefit due to a lack of data. Because the manufacturers Boehringer Ingelheim and Lilly submitted only one dossier, in which the added benefit compared to the already existing on the market Gliptinen was presented. In order to arrive at a fair evaluation, the gliptins should now also be checked and compared with a generic therapy. (Fp)

Picture: Andrea Damm