Switching patients to biosimilars in inflammatory disease: exploring patient and physician perspectives
What are the important considerations surrounding switching from reference products to biosimilars? And how do these vary between physician and patient viewpoints? Here we explore the importance of patient-physician communication, and the need for shared decision-making.
As patents for biologics expire, opportunities are created to prescribe biosimilars in therapy areas such as immune-mediated inflammatory diseases (IMIDs). The use of biosimilars can mean earlier and wider access to much-needed treatments for patients, due to the reduced cost compared to biologics.1
A recent article by Edwards et al points out that, while physicians and treatment-naïve patients may readily accept the concept of starting treatment with a biosimilar, there are various considerations that must be taken into account when switching a patient who is currently stable on a biologic, to a biosimilar.1
The authors conclude that empowering patients, by making them part of the decision-making process and informing and supporting them through patient education programs, is key to successfully switching from biologics to biosimilars.1
Here we look at both physician and patient considerations in the switching process.
Physician knowledge and education around biosimilar development, manufacture and approval
Edwards et al found that, if a physician does not feel confident in their knowledge of how biosimilars are developed and made, they may be hesitant to prescribe biosimilars and/or switch patients to them. They may have reservations around the shorter approval process required for biosimilars versus biologics and feel that this could pose a potential safety risk.
The article states that physicians need reassurance that extensive data have been generated about the biosimilar that demonstrate similar quality, efficacy and safety to the reference product.1
Similarly, due to a lack of familiarity with the approval process, the authors report that physicians may be concerned by how data in one indication can be extrapolated for a biosimilar to gain approval in further indications.1
Physician concerns around consultation times
The article by Edwards et al claims that physicians may be concerned that explaining a switch from a biologic to a biosimilar to a patient will be a time-consuming conversation, and/or could lead to the need for more consultations, which physicians fear could cancel out the very cost-savings that the switch is intended to achieve.1
However, contrary to the above theory, a registry study in Denmark did not find any evidence of an increase in outpatient visits following a switch from the biologic infliximab to the biosimilar CT-P13 in patients with arthritis.1,2 So the evidence is not clear-cut and even if, in the short-term, more consultation time is needed to reassure patients about switching to a biosimilar, surely the long-term gains would make this worthwhile.
Patient reluctance to switch
If a patient is happy with their current medication, it is only natural that they may be reluctant to change treatment. There is a risk that they could experience the ‘nocebo’ effect, which is the opposite of the placebo effect. Edwards et al describe how simply knowing that they are taking a different medication may cause patients to perceive a loss of efficacy, or experience the onset of adverse events that they attribute to the biosimilar.1
Patients may report such negative associations with the biosimilar, even in the absence of any evidence of altered disease activity. In fact, it has been shown that patients are more likely to discontinue treatment with a biosimilar when they know they have been switched - i.e., in open-label studies - than when they are unaware of whether they have been switched or not – i.e., in double-blind studies.1,3
Another patient concern is being switched from a biologic to a biosimilar without being informed. In Europe, such automatic substitution is strongly opposed in favour of open communication and joint decision-making between patients and physicians.1
The importance of the delivery device
In disease areas such as arthritis, there is a huge opportunity for biosimilars when it comes to innovations in delivery devices. Because dexterity can be an issue for patients with arthritis who self-administer their treatment, any improvement in ease of use compared with the reference product’s delivery system can impact on both the patient’s and the physician’s attitude towards switching.1
Overcoming physician and patient barriers towards switching to biosimilars
Real-world studies can supplement the evidence supplied by randomised controlled trials in order to increase confidence in prescribing and inform best practice. In addition, biosimilar manufacturers need to engage with physicians through information and education in order to build trust.1
It is important that patients receive education on biosimilars for them to feel confident that they can receive as much benefit from a biosimilar as they can from a biologic.1 The more engaging and concise the information the better.
Patients can also be educated on the benefits to society of biosimilars, due to the potential cost savings enabling a greater number of patients to be treated - especially earlier on in the disease pathway.1
We should not approach all patients as though they were identical. The Beliefs about Medicine Questionnaire, for example, can reveal if a patient is sceptical, indifferent, accepting or ambivalent.4 This enables communication to be tailored to them based on their current attitude towards biosimilars in a way that will resonate and reassure.1
So in summary, it is clear that biosimilars represent a fantastic opportunity for more patients to receive treatments they need, earlier in the treatment pathway. A big challenge, when seeking to maximise the cost-saving potential of biosimilars, is overcoming the barriers to switching from a biologic. Educating all parties about the benefits of biosimilars is key.
1. Edwards CJ, Hercogováb J, Albrandc H and Amiot A. Switching to biosimilars: current perspectives in immune-mediated inflammatory diseases. Expert Opinion on Biological Therapy 2019. https://doi.org/10.1080/14712598.2019.1610381; 2. Glintborg B, Sorensen J, Hetland ML. Does a mandatory non-medical switch from originator to biosimilar infliximab lead to increased use of outpatient healthcare resources? A register-based study in patients with inflammatory arthritis. RMD Open 2018;4(2):e000710.; 3. Odinet JS, Day CE, Cruz JL, et al. The biosimilar nocebo effect? A systematic review of double-blinded versus open-label studies. J Manag Care Spec Pharm 2018;24(10):952–959.; 4. Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychol Health 1999;14(1):1–24.