Dapagliflozin - vanishes new drug for diabetes therapy on the German market?

Press Release: German Diabetic Association (DDB)
German Confederation urges diabetics receiving effective treatment options
Diabetes patients are modern drugs available that reduce blood sugar effectively today. However, for reasons of cost fall more and more diabetes medications from the refund. The latest example: "dapagliflozin" (trade name: "Forxiga"). According to a decision of the Federal Joint Committee (G-BA) in June of SGLT-2 inhibitor has no additional benefit compared to conventional preparations. The German Diabetic Association (DDB) considers this decision - especially in international comparison - for "totally inconclusive" and fears a health risk to the patient.

Dapagliflozin is the first compound of a new group of diabetes drugs, the SGLT-2 inhibitors. It follows the principle of action, that more sugar is excreted in the urine, so can blood sugar, blood pressure and body weight reduction.


Both the German Diabetes Society (DDG) and the Scientific Advisory Board of the German Diabetes Association (DDB) agree that the favorable effect of any combination of the previously available orally taken medicines for diabetes is achieved. Especially patients who are at risk of hypoglycaemia, benefit from the drug. "One crucial criterion for the patient is also delaying insulin therapy," explains the DDB national chairman Dieter Mohler.

The drug was approved in November 2012 for the treatment of type 2 diabetes - as monotherapy and in combination with other glucose-lowering agents including insulin, since January 2013 dapagliflozin is prescribed in Germany. 16,000 diabetics get here already the drug.

The G-BA has now examined four applications of the preparation: the mono-or combination therapy with metformin, other hypoglycemic drugs or insulin. And comes to the same conclusion as the Institute for Quality and Efficiency in Health Care (IQWiG): no additional benefit for any of the treatment options. This is justified by alleged methodological flaws of the underlying studies, also considered as side effects of the drug including urinary tract or genital infections. "What matters are but patient preferences, where on a reduction of long-term blood glucose levels and HbA1c avoid hypoglycaemia are in the foreground - only as a final point be called side effects," Mohler makes clear.

While providing in Germany that the new diabetes drug falls from the policy, have prestigious scientific institutes in Europe of an additional benefit of the drug out - United Kingdom (NICE), Scotland (SMC) and Denmark (SST) are the preparation Based on identical studies positive about. "How can it be, is that presented a different result in Germany compared for example to the British review? International standards, it must nevertheless be applied evidence-based medicine", criticized the DDB national chairman and urges the Federal Ministry of Health (BMG) on to complain about the G-BA decision.

Is the BMG but the green light for the G-BA decision diabetics remain in Germany expected a modern and promising medication withheld, the (EMA) has already received wide approval from the European Medicines Agency. In patients who are already taking the medication, therapy must be changed again if necessary. Dieter Mohler: "The DDB does everything that diabetics maintain this new and effective treatment option."