Blinatumomab Wins CMS Favor Following Reevaluation

An immunotherapy developed by Amgen and approved by the FDA for the treatment of acute lymhoblastic leukemia in December 2014 has now received coverage assurance from Medicare, following an initial rejection of the expensive drug that costs $178,000 for a standard course.

Blinatumomab (Blincyto) was granted accelerated approval for treating Philadelphia chromosome—negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Evidence submitted to the FDA showed that 32% of 185 adults with B-cell ALL had complete remission for more than 6 months following drug infusion.

This new approval from CMS is for the “add-on payments” made to hospitals for new technology whose costs are not yet reflected in the standard lump-sum amounts that hospitals receive for treating patients with a particular disease or disorder. New information submitted by Amgen convinced the decison-makers at CMS of the "value" that blinatumomab would render compared with exisiting treatments for B-cell ALL.

Read more at The New York Times.