The Challenge of Educating Patients on Biosimilars

While provider education on biosimilars presents a hurdle for health systems worldwide, patient education is also an area of significant need. During the fifth DIA Biosimilars Conference, held October 22 to 23, 2018, in London, United Kingdom, several stakeholders addressed this challenge.

Reaching the Patient Through the Provider

For Arnold Vulto, PharmD, PhD, FCP, professor emeritus of hospital pharmacy and practical therapeutics as Erasmus University Medical Center in Rotterdam, the Netherlands, provider education must be the first step toward instilling confidence in patients.

The Dutch healthcare system, he explained, has taken a tailored approach to provider education through development of the Biosimilars Toolbox, a joint initiative from the Dutch Association of Hospital Pharmacists and the Federation of Medical Specialists. The toolbox, launched in April 2017 (and so far available only in Dutch), is a practical guide for implementation of biosimilars that includes scientific background material and position papers, information about using biosimilars in new and existing patients, a roadmap for implementing a switch, policies for transitioning, and informational materials for patients.

The toolkit relies on a multi-stakeholder approach that includes everyone involved in a switching program, from providers to patients to hospital staff. It also operates on a “one voice” principle that emphasizes synchronized messaging from all members of a healthcare team to avoid potentially creating a nocebo effect in patients.

Vulto also emphasized the need for shared decision-making with the patient and for gain-sharing structures that will allow those implementing the switch to benefit from cost savings produced through biosimilars.

Vulto is also active in the Dutch Biosimilar Education Program (BOM), a voluntary, no-cost program for health systems that aims to increase knowledge of biosimilars and stimulate prescribing of cost-effective therapies. The BOM program offers an inventory of the hospital’s current situation with respect to biosimilars, including a review of the efficiency of the drug procurement process. It also offers a tailored educational program for all stakeholders, which includes lectures, classes, workshops, and online offerings, as well as biannual assessment of progress.

Combatting Misinformation

According to Hillel Cohen, PhD, executive director of scientific affairs at Sandoz, negative comments that could undermine provider and patient confidence in biosimilars are common.

Cohen pointed to a 2018 physician survey, conducted by FirstWord Pharma, that found that 33% of respondents had heard negative statements about biosimilars, and approximately half of those who had encountered such statements said that they had heard them from reference product sponsors.

Some recent areas that have been subject to misinformation, said Cohen, include quality, the extrapolation of indications, and nonmedical switching.

Cohen has encountered claims that biosimilars are of a lower quality than their references, and that interchangeable products are superior to noninterchangeable biosimilars. However, he pointed out, the same quality standards exist for all biologics in the United States and European Union, and because of advancements in technology, a biosimilar may even have lower immunogenicity or impurity levels than its reference. And while interchangeability studies require multiple switches, the quality of the products is the same.

Cohen also reports having heard claims that the safety and efficacy of extrapolated indications is uncertain, but as he points out, extrapolation has been used for decades in the context of major process changes. Furthermore, extrapolation is based on the totality of the evidence, not on the clinical physiology of one indication versus another. If the structure and function of the molecules are the same, he said, they will have the same effect on the patient.

Perhaps most concerning for Cohen, however, is growing patient anxiety about nonmedical switching. In Cohen’s view, the term “nonmedical switching” should not be applied to the biosimilars context, because patients who switch from a reference to a biosimilar are not receiving a new therapy. To use the term, he said, is to conflate switching among products that have different structures with switching between a reference and a biosimilar, potentially sowing unfounded concerns.

Cohen recounted an FDA advisory committee hearing that he attended, saying that numerous individuals took the floor to voice concerns on nonmedical switching. “When everyone gets up there and talks about the same topic, you know it’s been coordinated,” he said, suggesting that baseless fears are being stoked.

While Cohen acknowledges that “nonmedical switching” has become established in the medical literature, he feels it should be replaced with “transitioning.”

Forging Relationships With Patients

Robert Johnstone, a patient advocate and board member of the European Forum for Good Clinical Practice, challenged the common perception that patients lack awareness of or concern about the need for biosimilars to reduce costs for healthcare systems.

Immediately after a diagnosis with a chronic condition, said Johnstone, patients tend to focus solely on getting the right treatment. Yet as time progresses, patients tend to broaden their perspective from what can help them relieve their symptoms. “They begin to see health in a broader context and how society can afford those treatments,” he said.

“I want to raise the concept of the patient not as a passive recipient of healthcare,” he went on, explaining his vision of what he termed “emancipatory healthcare,” in which understanding one’s own condition and working jointly with others can help the system to improve and find efficiency and sustainability.

For Johnstone, education about biosimilars should not only flow from provider to patient, but also from trained patients to their peers. Educating patient advocates to disseminate reliable information to other patients not only frees up providers from the task, but could also provide a potential employment opportunity for patients with chronic diseases.

Crucially, said Johnstone, other stakeholder groups need to engage patients throughout decision-making processes concerning switches to biosimilars, not merely “parachute a patient into a process to deal with one issue.” Building trust among patients requires time, effort, and a relationship built on shared understanding.