IQWiG releases Adcetris cost estimate
Germany's Institute for Quality and Efficiency in Health Care (IQWiG) estimated that Orphan drug Adcetris brentuximab vedotin from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) will cost the German statutory health insurance funds (GKV) EUR 6.1-EUR 53.4 million ($8.1-$70.6 million) per year. If the institute's maximum estimates are accurate, the lymphoma drug would have to undergo a formal benefit assessment in Germany despite being an Orphan product. Takeda estimates Adcetris will cost the GKV EUR 14.5-EUR 28.9 ($19.2-$38.2 million).
Under drug pricing law AMNOG, the additional benefit of Orphan products is regarded as having been demonstrated by marketing authorization. IQWiG does not conduct a formal benefit assessment of Orphan products until they have annual sales within the German statutory health insurance system of EUR 50 million or more. G-BA still determines the extent of the additional benefit; a final decision from G-BA on the extent of Adcetris' benefit is expected mid-May. ...