Stop G-BA decision on dapagliflozin: DDG
The German Diabetes Society (DDG) appealed in a statement to the Federal Ministry of Health, the decision of the Joint Federal Committee (G-BA) to complain against the diabetes drug dapagliflozin.
The G-BA had its first approved drug from the group of SGLT-2 (sodium-glucose linked Transportation2) inhibitors on 6 June 2013 an additional therapeutic benefit denied. SGLT-2 inhibitors reduce blood sugar by sugar excretion in the urine. But studies show that among dapagliflozin less severe hypoglycaemia occur as in therapy with sulfonylureas.
"Avoiding severe hypoglycemia for patients is a very important added value," DDG-President is Professor Dr. Erhard seal. In addition, the DDG questioned the legitimacy of the G-BA decision clearly due to procedural defects. Thus, the DDG had not been sufficiently involved as a scientific society in the process of evaluating dapagliflozin, criticized seal. "The expertise of the DDG could help to eliminate methodological flaws," said the DDG-President.
Maximum dose: Do not be reached
One such flaw is the fact, for example, evidence-based guidelines do not take into account: The G-BA had complained, among other things, that the diabetes drug metformin has not been given in the submitted studies in a maximum dose of 3,000 milligrams. "The maximum dose is given in the SPC as the highest recommended dose, but does not have to be achieved," says tight seal. Accordingly, no recommendation generalize the use of 3000 milligrams of metformin in the evidence-based guidelines of national and international companies find diabetes.
In addition, the German Diabetes Society could not reply to some arguments against the added benefits of dapagliflozin - have been published only in the wake of the G-BA decision against dapagliflozin. "In this context we also criticize that the negative assessment of the scientific experts against dapagliflozin was not justified," warns seal. "That does not speak for transparency and also not of good scientific practice."
No doubt about the added benefits of dapagliflozin
From the perspective of the DDG there is no doubt about the added benefits of dapagliflozin. "Numerous studies have shown that among dapagliflozin serious life-threatening hypoglycaemia occur much less frequently than with sulfonylureas," says Siegel. The safety of medicines from the perspective of the DDG clearly put a significant additional benefit dar. "For this reason, we call on the Federal Ministry of Health, objecting to dapagliflozin decision of the G-BA, effectively to stop," says Siegel.
The Ministry of Health has the responsibility to review the decisions of the G-BA. Only at a non-objection by the Federal Ministry of Health, they are published in the Federal Gazette and thus legally effective.
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