Iclusig ponatinib regulatory update

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) agreed with estimates from Ariad that would place the cost of Orphan drug Iclusig ponatinib to the German statutory health insurance funds (GKV) at more than €50 million ($67.8 million) per year. IQWiG agreed that about 780 patients would be eligible for treatment with Iclusig at an annual cost of €77,830.35 ($105,491.26) per patient, for a total cost to GKV of €60.7 million ($82.3 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 breach the €50 million annual sales threshold. Germany's Federal Joint Committee (G-BA) still determines the extent of the additional benefit; a final assessment from G-BA is expected in late January 2014. Iclusig is a pan- BCR-ABL tyrosine kinase inhibitor (TKI). ...