Nonmedical Biosimilar Switch Results Surprise Investigators

Damian McNamara

June 30, 2017

MADRID — When the first biosimilar for infliximab, CT-P13, was approved in Denmark in 2015, the government mandated that patients switch to the biosimilar, which was 64% less expensive at the time. However, there was concern that an increase in the use of healthcare resources, because of patient and physician anxiety about the new class of agents, would offset the cost savings.

"This was the first nonmedical switch that happened," said Bente Glintborg, MD, PhD, from the Copenhagen Center for Arthritis Research and the DANBIO registry.

"Patients were anxious, physicians were anxious, and the patient societies were anxious," she told Medscape Medical News.

"I expected some worrying, and that the patients would call and come in a lot," she said here at the European League Against Rheumatism Congress 2017.

In their study, Dr Glintborg and her colleagues assessed total healthcare services used and the number of days with healthcare services used in the 6 months before and the 6 months after the switch.

During the 12-month study period, 1484 outpatient visits were made by 769 patients with rheumatologic inflammatory diseases. In total, 19,752 individual services were provided, and about 10% of those were on the switch date.

And of the 9243 days on which at least one service was provided, 693 — or approximately 7% — occurred on the switch date.

There was a slight increase in the mean number of days with services from before the switch to after (5.4 vs 5.7; P = .0003).

"We found that there were some significant differences in higher use after than before," Dr Glintborg explained, "but the numbers were very similar." The difference was statistically significant because of the large number of patients, "but not clinically meaningful."

"I was surprised, actually. I had expected a higher use of services after," she added. "These patients were well treated for almost 7 years with the originator drug, so of course they were worried. It's another drug from another company with a different name."

Table. Mean Number of Services Used Before and After Drug Switch

Service Before Switch After Switch P Value
Infliximab treatment 3.10 2.96 <.01
Clinical control 2.07 2.26 <.01
Phone consult 1.03 1.17 .03
Patient guidance 0.35 0.49 <.01
Clinical investigation 0.31 0.47 <.01
Observation 0.17 0.22 <.01
Intravenous medication 0.03 0.11 <.01


Differences between the two time periods were not significant for services related to nursing activity, methotrexate treatment, blood pressure measurement, conventional synthetic disease-modifying antirheumatic drugs (DMARDs), venous needle, conversation about treatment, ultrasound over extremity joint, or ultrasound under extremity joint.

"This analysis showed that there were only small differences in the rate of days with outpatient services and rates of services 6 months before and after the switch from original to biosimilar infliximab," the researchers write in their abstract. "Thus, it is unlikely that the switch is associated with substantially higher cost of healthcare resources."

"The clinical significance of the findings is that the services used before and after switching to a biosimilar from a bio-originator were not different," said Désirée van der Heijde, MD, from the Leiden University Medical Center in the Netherlands.

"That is an indirect way of showing that there are no specific concerns by the patients after the switch, which would have led to the use of more services. There were significant differences in a few variables but, numerically, the data were very similar," she told Medscape Medical News.

In a separate Danish study, people with rheumatoid arthritis or psoriatic arthritis were interviewed 9 to 12 months after the mandatory switch.

"We asked patients what concerns, issues, and thoughts they had about nonmedical switches from an originator to a biosimilar," said Tanja Schjødt Jørgensen, PhD, from Copenhagen University Hospital.

In most cases, patients reported that "a lack of information and a lack of communication" made them "insecure about the switch," Dr Jørgensen told Medscape Medical News.

Even when clinicians shared data pointing to the clinical equivalence of a new biosimilar, many patients remained unhappy, she explained. They understood the economic reasons for the switch, but didn't like the element of surprise, their lack of involvement in the decision, or the relatively short amount of time they were given to process the change.

The Danish government required everyone to switch within a 2-month period, so there was limited time for patients to get their questions answered. "It would have been less scary" for the patients if the process had been longer, Dr Jørgensen pointed out.

Nonmedical switches are particularly worrisome for rheumatoid or psoriatic arthritis patients in remission on a particular biologic. "They're taking a medication that for many makes their lives worth living again," she noted.

Dr Glintborg reports receiving grant and research support from AbbVie. Dr van der Heijde reports receiving consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, and UCB. Dr Jørgensen reports being on the speakers' bureau for AbbVie, Roche, Novartis, UCB, and Biogen.

European League Against Rheumatism (EULAR) Congress 2017: Abstract THU0468. Presented June 15, 2017.

Follow Medscape Rheumatology on Twitter @MedscapeRheum and Damian McNamara @MedReporter


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