Masterarbeit

Regulatorische Analyse der frühen Nutzenbewertung von Linagliptin, einem innovativen oralen Antidiabetikum

Dr. Gabriele Sigl-Seifert (2012)

Summary

The German Law for Reforming the Market for Pharmaceuticals (AMNOG) came into force on January 1st, 2011. Pursuant to AMNOG a benefit assessment by the Federal Joint Committee (G-BA) for medicinal products containing new active substances becomes obligatory after approval and marketing in Germany. The outcome of the new benefit assessment procedure is crucial for the reimbursement by the public health insurance one year after approval.

The core requirement of the benefit assessment is a comparison to standard of care of the benefit of the new medicinal product in its approved indications by means of evidence based medicine having regard to differences in mortality, morbidity and quality of life. Trajenta (active substance: Linagliptin) was the first oral drug approved for the treatment of type 2 diabetes which was assessed according to the new legislation. The comparator(s) regarded as established medicines and determined by the Federal Joint Committee were Sulfonylureas, resp. Metformin and Insulin. No additional benefit was stated for Trajenta, because the marketing authorization holder insisted to compare Linagliptin within its own class of active substances the DPP-4 -inhibitors. In general clinical study data corresponding to the relevant clinical guideline in the past and appropriate for approval by EMA are not sufficient to fulfill the requirements of the G-BA. Proposals for improvement of the current benefit assessment procedure are outlined.

Pages: 59