Fraser Cummings, MBChB, DPhil, led one of the first clinical teams to switch patients receiving the reference infliximab (Remicade) to CT-P13 (Remsima) in UK clinical practice. During the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, Cummings explained his experience with this switch in his gastroenterology clinic, and looked ahead to the arrival of adalimumab biosimilars in the National Health Service (NHS).
Fraser Cummings, MBChB, DPhil, University Hospital, Southampton NHS Foundation Trust, led one of the first clinical teams to switch patients receiving the reference infliximab (Remicade) to CT-P13 (Remsima) in UK clinical practice. During the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, Cummings explained his experience with this switch in his gastroenterology clinic, and looked ahead to the arrival of adalimumab biosimilars in the National Health Service (NHS).
For Cummings, the need to switch his patients with inflammatory bowel disease (IBD) to a cost-saving biosimilar infliximab was clear: “I work for a really cash-strapped system…it’s bankrupt,” he explained. In looking to the future of the health system, it is imperative to find savings within the NHS in order to make room for new, high-cost therapies that patients will not otherwise be able to access.
The key to making a switch and realizing the cost savings, said Cummings, was to align all stakeholders’ incentives. In the Southampton case, that alignment was achieved through a 3-year gain-sharing model, as reported in a paper published in the Journal of Crohn’s and Colitis,1 which allowed the hospital to share in the savings reaped through using the lower-cost biosimilar.
Cummings’ approach to gaining stakeholder approval of this agreement, he explained, started with educating his colleagues about biosimilars and their associated cost-savings. He also engaged a panel of patients—who convene every 6 weeks to provide feedback to the clinic about its performance and their experiences—to educate them and allow them to share their viewpoints on the switch.
“What [patients] will see is a change to their treatment,” so it is key that patients see positive benefits as a result of a switch. In the first 4 months of the arrangement alone, said Cummings, the switch saved £293,000 pounds (approximately $385,666), and the hospital has used its portion of the funds to hire an IBD specialist nurse, hire additional clerical staff, and offered added dietetic and pharmacy services at the clinic, all of which directly improved the patients’ care experience.
In looking ahead to the October 2018 arrival of biosimilar adalimumab in the NHS, Cummings says that while there is the potential for deep cost savings with biosimilars, a transition to using these agents may not be as smooth as the transition to biosimilar infliximab.
“[When] I look at my hospital, we have over 600 patients treated with adalimumab. Even if you think of the best, slickest switching program,” each patient would need a minimum of 30 minutes of discussion about a change to their treatment, and his staff do not have the resources to quickly educate patients about a change in adalimumab therapy. “Clinical teams are on their knees,” said Cummings. “They simply don’t have the manpower.”
Given how competitive the biosimilar adalimumab market will likely be, with multiple players entering the space at the same time, Cummings thinks that hospitals might have to switch patients among adalimumab products—and among biosimilar adalimumab products—on an annual basis. “In my mind, every year, this will be a process that we’ll go through,” he said, adding that more nurses and a dedicated pharmacist will be necessary to facilitate a switch.
Considering these multiple switches, Cummings encouraged developers to publish data comparing their products not only to their references, but also to other biosimilars. While most clinicians are comfortable with biosimilars and with the extrapolation of indications, they may still see switching among biosimilars as questionable given the potential for all biologics and biosimilars to cause immunogenicity. “We haven’t seen a problem with change in immunogenicity, but the interchangeability question is really challenging,” he said. “Get the data out of your labs and into the press so people can see it and review it and be reassured by it,” said Cummings.
He also called on developers to keep the patient top of mind; delivering the drug to the patient well should be a prime concern for developers, and they should provide reassuring materials and patient education to help overcome any potential nocebo effect.
1. Razanskaite V, Bettey M, Downey L, et al. Biosimilar infliximab in inflammatory bowel disease: outcomes of a managed switching programme. J Crohns Colitis. 2017;11(6):690-696. doi: 10.1093/ecco-jcc/jjw216.