Biosimilar Education Roundup: January 2019

While the body of reassuring data on the safety and efficacy of biosimilars continues to grow, worrisome information about stakeholders’ levels of awareness of these products is also coming to light, and January 2019 saw the publication of a spate of studies showing low levels of patient and provider education on biosimilars.

First, in the results of a recent patient survey, the UK advocacy group The Patients Association reported that among patients who had been switched to a biosimilar, 37% had not been consulted about the switch, even though National Health Service guidelines require patient consultation before undertaking a switch.

Patients also reported “a very poor experience” with the process of the switch, citing a lack of information and a lack of choice. The Patients Association called for better information, shared decision making, and collaboration between patients and their clinicians as a means to better inform and empower patients.

Informing patients about biosimilars is also proving to be an issue in the United States; in newly published survey results, investigators found that nearly 43% of oncology providers said it was only somewhat important or not at all important to inform a patient if they had been prescribed a biosimilar, and 39% of respondents said that shared decision making was only somewhat important or was not at all important.

Despite some clinicians’ views that patients do not need to be informed about biosimilars or involved in the decision-making process, a lack of education about biosimilars appears to be linked to increased reporting of adverse events. A study of Italian individual case safety reports among patients taking biosimilar infliximab versus those taking the reference drug showed that after the marketing availability of biosimilars, the number of reports increased, which could correlate to greater availability of infliximab therapy, but could also be linked with greater concern about biosimilars’ safety.

Also of concern is patient discontinuation of biosimilar therapy due to the nocebo effect, or an effect whereby a patient experiences worse outcomes because of negative beliefs about a treatment. A systematic literature review reported that higher-than-expected discontinuation rates of biosimilars have been observed in the real-world setting, and because these rates can be attributed in part to subjective factors, higher discontinuation rates could be a result of the nocebo effect.

Discontinuation was also a concern raised by a French cross-sectional study among patients with rheumatological diseases. More than half of patients surveyed said that they would be wary of accepting a switch to a biosimilar and might interrupt their treatment if they were concerned about the transition.

Other research highlighted the fact that an overabundance of detail in package leaflets for biosimilars may not be helping patients to feel more informed about their course of therapy, either. A study of available leaflets showed that biosimilars’ materials were longer than those of reference biologics and more difficult for patients to understand. Information about anti—tumor necrosis factor drugs were particularly long and challenging. According to the authors, excessive or confusing detail could alarm patients and reduce adherence.

Data published this month also show that it’s not just patients who are not yet receiving appropriate education; troublingly, providers also continue to lack awareness of biosimilars. A systematic review of studies on provider awareness in both Europe and the United States found that clinicians reported having concerns about biosimilars’ potential immunogenicity; a 2016 survey found that 23% of providers believed biosimilars to have a higher risk of immunogenicity than reference products, and more than 60% of providers in a 2017 survey reported similar concerns about immunogenicity.

In order to address such gaps in knowledge, some stakeholders are attempting to educate their peers through contributions in peer-reviewed literature. For example, one new paper sought to disambiguate the concepts of interchangeability, substitution, and physician-mediated switching in the US context.

Furthermore, nurses are being encouraged to play a role in educating patients, given their key role in communicating with and managing patients. In the European context, pharmacists are also taking a hand in education; the UK National Health Service’s Specialist Pharmacy Service has released new information on citrates in biosimilar adalimumab formulations, which have given some patients concern about increased discomfort in self-administration.

Beyond providers, other stakeholders can have a key function in increasing patient confidence in their treatments; one Canadian payer reported that in a pilot switching program, hiring dedicated care-coordinator nurses and providing a dedicated phone line for patient support helped to address any issues or answer any questions that patients had about switching to a biosimilar.

The biosimilars industry itself is also becoming increasingly aware that it must play an educational role; during a presentation at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia, Chrys Kokino of Mylan said that the industry has to make sure its voice is represented at medical and scientific meetings as well as in peer-reviewed journals, editorials, and review articles.