Rethinking the Patient Perspective on Biosimilars

Often left out of the discussion about switching to biosimilars is the perspective of a particularly key stakeholder group: patients. During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21-22 in Porto, Portugal, Francois-Xavier Frapaise, MD, principal of F.-X. Frapaise Consulting, sought to describe current challenges and emerging solutions in gaining patients’ trust in biosimilars and suggested that biosimilars can be an opportunity to “resuscitate the social contract.”

One factor to which Frapaise pointed as a reason that patients question whether they would accept biosimilars is that clinical trials do not necessarily take into account patients’ own view of their disease. Patients with rheumatoid arthritis, he said, aren’t thinking in terms of the American College of Rheumatology’s criteria for a 20% improvement (ACR20). Instead, they are thinking about how much of an impact their symptoms have on their daily life activities. While that fact does not mean that ACR20 lacks utility as an end point, “you have to go beyond that,” and clinical trials should include patient-reported outcomes (PROs).

Furthermore, in patients who are taking part in a switch that will be the subject of a real-world study on that switch, it is important to make sure that patients are aware of what they are signing up for; research indicates that participants in real-world settings do not always get good information about providing their informed consent. Frapaise also suggests providing patients with multilingual videos or other retention aids to improve recall and comprehension.

It is also key to address providers and encourage them to educate themselves and their patients; over time, some groups of clinicians, such as gastroenterologists, have become more accepting of biosimilars that have not been expressly studied in the disease states that they treat (although Frapaise noted that “I don’t see switching in oncology any time soon”). While more providers are using biosimilars, and while clinicians in most countries have a legal obligation to inform patients that they are taking a biosimilar, poor communication and time constraints mean that this obligation is unfortunately “loosely applied.”

Other important steps that biosimilar developers can take include working with patient groups. Frapaise highlighted Patient-Centered Outcomes Research Institute, and its European equivalent, the European Patients’ Academy, as examples of excellent patient resources that use health data and patient partnerships and allow well-informed patients to help educate their communities.

Patient advisory boards can also be useful; patients can help researchers identify unmet medical needs, determine which protocol hypotheses spark patient interest, identify barriers to clinical trial participation, and advise on recruitment. Patients can also help with their input on drug design, risk-benefit insights, patient-friendly informed consent materials, and the development of PRO measures.

In working in partnership with patients, Frapaise emphasized, it is important to understand that that one-off meetings are not enough; long-term relationships are key, and it is essential to plan ahead to develop these relationships.

Developers should not ignore the importance of the internet and social media, either; patients seek information online, and they are informed about their conditions to a high level, although they may not have the right filters to ensure that they are getting high-quality materials. Developers should consider engaging with entities such as PatientsLikeMe, a patient network and research platform, as a place to engage patients.

Furthermore, developers should not let misleading statements about biosimilars that could influence patient perception go unchecked. Just as one would not leave luggage lying unattended in the airport, one cannot allow misinformation from any quarter to improperly influence the conversation about biosimilars.

Finally, according to Frapaise, there exists a need for patients to understand the context for biosimilars; patients may fear that they’re being offered a suboptimal treatment and may not understand that their acceptance of a safe and effective biosimilar can actually create cost savings to allow for other patients to be treated. From a philosophical perspective, said Frapaise, “I suggest that adoption of biosimilars is one expression of a renewed social contract” in which individuals accept a limitations in exchange for solidarity and the benefit of the social body. While doing so may pose a hurdle in some cultural contexts, such as the United States, the opportunity to advance the good of society, according to Frapaise, is substantial.