Benefit assessment of antidiabetic agents

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All gliptins should be checked

The Federal Joint Committee (GBA) has ordered a benefit assessment of all gliptins, thus extending this form of drug assessment to the existing market for the first time. Antidiabetic drug manufacturers are required to submit the necessary dossiers by December 31. The evaluation process will then start in January 2013, according to the Federal Joint Committee.

The fact that the benefit assessment, which has been planned since the entry into force of the Medicinal Products Reorganization Act (AMNOG) on January 1, 2011, is extended for the first time to existing medicinal products is due to a scandal surrounding the GBA decision on the active ingredient linagliptin. The GBA was unable to identify any additional benefit on the basis of the available documents, so that the health insurance companies would only have reimbursed the fixed amount intended for generics. The prices that the manufacturers were able to achieve were clearly too low and, in addition, an unfavorable signal effect was expected in other countries, so that the introduction of the drug against type 2 diabetes was not introduced on the German market. In order to achieve a fair assessment, the long-approved antidiabetic drugs sitagliptin, vildagliptin and saxagliptin as well as the drug combinations metformin / sitagliptin and metformin / vildagliptin are to be subjected to a corresponding benefit assessment.

Benefit assessment of the gliptins required for reasons of competition The GBA chair Dr. Rainer Hess explained that, for reasons of competition, a benefit assessment of all gliptins - including those already on the market before the AMNOG came into force - had to be carried out. Otherwise, the manufacturers of older preparations would have an unreasonable advantage over manufacturers of active substances of the same substance class that are currently being brought onto the market. With regard to medicines that were brought onto the market before January 1, 2011, the manufacturer's price freedom is not limited by the benefit-dependent reimbursement amount. The central association of statutory health insurers (GKV) negotiates with the pharmaceutical manufacturers on the basis of the GBA's assessment of the benefits of the active substances, which amount is to be set for reimbursement.

Antidiabetic drugs without added benefit? In the case of linagliptin, the Federal Joint Committee assessed the benefit compared to therapy with generics and was unable to determine any additional benefit due to the lack of data. The manufacturers Boehringer Ingelheim and Lilly only submitted a dossier in which the additional benefit compared to the gliptins already on the market was presented. In order to arrive at a fair assessment, the gliptins should now also be checked and compared with a generic therapy. (fp)

Image: Andrea Damm /

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