Conclusion: Amgen’s Blincyto (blinatumomab) shows minimal efficacy and tolerability gains over older multi-drug induction regimens, yet it is priced at around $200,000 for a full course of treatment. If the company succeeds in expanding the drug’s label, it is likely to face pressure to lower the price significantly unless it can show considerably more clinical improvement in those expanded patient populations.
In December 2014, the FDA approved Blincyto (blinatumomab) for 2nd line treatment of a rare form of acute lymphoblastic leukemia (ALL). The addressable patient population is so small that Blincyto usually wouldn’t have drawn much attention, but it has been in the headlines due to its steep price. The drug is priced in line with other ultra-orphan drugs. But Blincyto doesn’t deliver the step-change in efficacy that other six-figure drugs have brought to the table. Before Blincyto’s approval, induction was carried out using various multi-drug regimens. Some are better than others, but none had become a universal therapeutic choice.
Blincyto does have an efficacy advantage over all of the multi-drug regimens, but it is incremental in most cases. Blincyto also has a slight side effect advantage, and it is likely more convenient for the infusion centers to dose (patients might not notice much of a difference). For all these advantages, Blincyto’s improvement in Clinical Innovation, or percent reduction in unmet medical need, is more than offset by its huge price, which is roughly an order of magnitude more than that of the multi-drug regimens. Blincyto is currently being trialed in larger ALL patient populations, as well as the largest subset of non-Hodgkin’s lymphoma patients. We expect there will be much more pressure on the drug price if Blincyto is able to gain a label in a larger patient population.