New Drugs in Germany under AMNOG – initial considerations

Dear All,

AMNOG has issues the first assessment reports on a variety of drugs with mixed results. An interview with Dr. Cornelius Erbe from the DAK has been published recently. It is interesting to see that when he has been asked about the future developments in Germany he stated that, “I think the pharmaceutical industry is currently faced with a very important change in the legal framework and the market environment. We are a little bit concerned about the thoroughness of this change, and politicians are thinking about readjusting the laws they have taken. So it might be that the future looks a little bit more positive than it does today.” Given that he is close to health policy making I am curious how things unfold. We will be getting back to this during the year.

IHS Global insights have also done a nice job in summarizing the ratings obtained so far. 

To remind you the scoring system applied in Germany is:

1: Major added benefit over comparator
2: Significant added benefit
3: Slight added benefit
4: Unquantifiable added benefit
5: No added benefit proven
6: Less than comparator

Pricing of drugs in Germany will be related to the scores. According to their review about 60% percent of new therapies have been rated between 4 to 1 and therefore are eligible for price negotiations with the association of the statuary sickness funds. Those scored below will only be able to obtain a referenced price in Germany.

These results clearly show the changed course that pricing and reimbursement for medicines has taken in Germany. Stay tuned for further follow up on the topic.



Chris Carswell said...

Dear Ulf

Are they defining benefit purely in terms of efficacy observed in randomised clinical trials?

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pharma industry is little conservative in germany than in USA.

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