re off-label market
Dew, as far as I know, off label use is always a grey zone. However, German hospitals barely know what one case of a particular DRG costs them and they effectively have no particular control over doctor's prescribing. A doctor substituting Atryn for the plasma-derived version will only potentially face a problem in getting his presciption approved for drugs which are particularly expensive, e.g. Etanercept, for which he has to ask for extra funds to prescribe them. Hence my assessment, that the off-label use in Germany as the EU's larget pharma market, may not be as insignificant as one migth think (always in comparison to the overall market size of the HD indication only), as long as Atryn does not aim for a price which would make it subject to the aforementioned special pre-authorization process. This would cover off-label use in the German hospital sector. The case is different and I would agree with you with respect to ambulatory care and doctors who are not directly employed by a hospital.
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