Cost the focus in biosimilar debate

The cost of biosimilars for governments and patients was central to a ‘pro’ and ‘con’ debate on biosimilars at the American College of Rheumatology annual congress

The highly anticipated ‘great debate’ pitted Jonathan Kay, MD, against Roy Fleischmann, MD, to attempt to sway the audience on whether it is safe, effective and cost-effective to switch patients between originator biologics and biosimilars.

Prolific biosimilar researcher and expert Dr Kay, a professor of medicine at the University of Massachusetts, was tasked with defending the use of biosimilars in his presentation, “The data supports that it is safe, effective and cost-effective to switch to a biosimilar.”

Dr Fleischmann, a  clinical professor in the department of internal medicine at the University of Texas Southwestern Medical Center, Dallas, gave the counter argument in his presentation, “The data is not convincing. One study cannot be generalized to all indications, and some studies suggest that it is not safe, not effective and not cost-effective to switch all patients (YET) to a biosimilar”.

Taking to the podium first, Dr Kay’s argument centred around the fact that the availability of biosimilars should decrease the cost of treating patients by introducing market competition. Biosimilars should also become more available to patients who have been unable to access originator biologics.

He said biosimilars were good copies of their originators and brought out the popular ‘go to’ argument of biosimilar proponents that originator biologics varied from batch to batch and were actually biosimilars of themselves.

US and European sourced Remicade were “essentially biosimilars of one another,” he told conference delegates.  

Addressing the issue of the safety of switching patients between biosimilars, Dr Kay said studies had shown no safety signals for switching.

For example, the finding from the DANBIO study of the higher number of people discontinuing the infliximab biosimilar CTP-13 (Adjusted absolute retention rates 83.4% for CT-P13 (95% CI 80.8%-86.2%) and 86.8% (95% CI 84.8%-88.8%; P=0.03) for infliximab, absolute difference of 3.4%) was likely due to a nocebo effect, he said.

Taking to the podium to argue the ‘con’ position Dr Fleischmann said it was still not certain from the evidence so far that an individual patient will maintain efficacy if switched from an originator biologic to a biosimilar.

He said that, in his opinion, the NOR-SWITCH study had not shown that CTP-13 was non-inferior to the originator infliximab in rheumatoid arthritis, ulcerative colitis, Crohn’s disease, psoriatic arthritis or psoriasis.

“Importantly we don’t know if switching amongst multiple biosimilars in an individual patient will be safe or efficacious,” he added.

He went on to focus on what he said was the question(s) of ‘utmost importance’: Are there considerable cost savings realized with the use of bsDMARDs which accrue to the patient and would there be greater access to biologics?

He said that there was an overwhelming agreement that the only legitimate reason to use a biosimilar was because of a marked reduction in cost and increased patient access. “If it’s not cheaper then there’s no value,” he told delegates.

He then went on to talk in great depth about the US drug pricing and payment system that currently benefited pharmacy benefit managers and vertical healthcare systems but not the patient or Medicare.

“Cost to patients and access are the real issues… I don’t get any benefit, my government doesn’t get any benefit, the only person that gets any benefit is the insurance company. I’m not taking that risk, if you want to call that nocebo, call it nocebo, I call it common sense,” he said.

In Australia the cost of biosimilars has been on the agenda, with the government currently consulting the medical world on a range of ‘uptake drivers’.

You can read our coverage here and here.

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