IQWiG estimates Kalydeco will breach EUR 50M threshold

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) estimated that Orphan drug Kalydeco ivacaftor from Vertex Pharmaceuticals Inc. (NADAQ:VRTX) will cost the German statutory health insurance funds (GKV) about EUR 52.3 million ($66.5 million) annually. If the institute's estimates are accurate, the cystic fibrosis (CF) drug would have to undergo a formal benefit assessment in Germany despite being an Orphan product.

In contrast, Vertex estimates Kalydeco will have an annual cost to GKV of about EUR 44.5 million ($56.6 million); whose estimates are correct won't be clear until Vertex has a year of German sales for Kalydeco under its belt next August. Vertex said it is evaluating IQWiG's assessment and will submit a response by Dec. 6 to Germany's Federal Joint Committee (G-BA), which requested the assessment. The company declined to comment as to whether it may consider lowering the price of Kalydeco to ensure the drug's cost to GKV is less than EUR 50 million, the threshold under which Orphan products do not have to undergo a formal benefit assessment. ...