Amgen’s newly approved Blincyto for a rare form of leukaemia will cost $178,000 per two-cycle course, making it one of the most costly drugs on the market.
The price tag looks likely to add fire to the debate about how health systems can afford to look after patients with orphan diseases, particularly in cancer which has seen a slew of new immunotherapies for highly-targeted patient populations reach the market in recent years with price tags upwards of $100,000 a year.
Amgen secured approval from the FDA for Blincyto (blinatumomab) earlier this month as a second-line treatment for Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukaemia, which affects around 6,000 patients in the US.
In trials patients received two cycles of Blincyto therapy, and the drug’s label indicates that they could receive up to three more cycles. Blincyto is due to be launched in the US – its first market – today.
The drug – the first anti-CD19 drug to be approved by the FDA and also the lead candidate in Amgen’s bispecific T cell engager (BiTE) antibody programme – had previously been awarded breakthrough status and a priority review for that indication.
Amgen said in a statement: “We believe the price reflects the significant clinical, economic and humanistic value of the product to patients and the healthcare system, for an ultra-orphan population with a dramatic impact on a serious illness.”
The company added that the price also reflects “the complexity of developing, manufacturing and reliably supplying innovative biologic medicines and local pricing, reimbursement and purchasing conditions and requirements.”
Analyst Michael Yee of RBC Capital Markets told Reuters that – assuming a 50% take-up for Blincyto – Amgen will make around $100m a year from the drug in ALL, although that could increase if it gets approved in additional indications, such as first-line therapy of ALL and relapsed non-Hodgkin’s Lymphoma (NHL).
Other analysts have suggested it could make as much as $500m a year at peak.