Pediatric Patients and Their Families Report Unique Concerns When It Comes to Biosimilar Switching

In the United Kingdom, a concerted effort has been made to engage and educate patients before switching to biosimilar adalimumab. For many patients, that has meant receiving letters from the National Health Service, receiving nurse training, and being provided with access to helplines. Yet, these strategies have been largely focused on adult patients; pediatric patients are also subject to switching, and, as a recent study found, these patients and their families have their own set of concerns about a switch to a biosimilar.

In a newly published paper, authors from University Hospitals Bristol NHS Foundation Trust and the Bristol Medical School in Bristol, United Kingdom, reported on a thematic analysis that assessed patient and parent perceptions of a nonmedical switch to biosimilar adalimumab. The analysis relied on interviews with 9 patients with juvenile idiopathic arthritis and their families, undertaken in person or over the phone, in 2018. The researchers then used an inductive approach to identify and develop themes from the interviews.

Among the themes they identified were issues related to the practicalities of administering adalimumab. Patients expressed anxiety about whether they would have access to the same device as they were currently using, and they had concerns about unfamiliar devices.

Some also said that they were concerned that the biosimilar might be more painful to use due to the presence of a citrate, though “some patients were able to balance a possible worse outcome on an individual level against a perceived benefit for society.”

Notably, several families expressed concern that the biosimilar might be yellow in color; they indicated that previous negative experiences with methotrexate, which was yellow, could cause the patients psychological distress.

A second theme the authors identified was related to concerns about the switch. Anxiety about side effects was “frequently expressed,” and some families said they were worried about the logistics of a switch. Several patients said that they feared that, because the biosimilar was cheaper, it may be inferior.

A third theme emerged: Nearly all respondents identified cost savings as a benefit of switching, and some pointed to greater access to adalimumab as an important factor. Patients also said that they felt that research data, generated as a byproduct of the switch, would be useful.

A fourth theme in the interviews was the fact that “a significant majority” of the respondents said they thought the biosimilar would probably have similar safety and efficacy as its reference. Even those who had voiced anxieties about inferiority acknowledged that there may be no difference in efficacy.

Finally, the last theme that emerged was that, for many respondents, anxieties and concerns were mitigated by the trust they had in the medical team. Even those families who had a negative view of the switch, say the researchers, did not blame their medical team.

According to the authors, while many anticipated that most major concerns about the switch to biosimilar adalimumab would relate to safety and efficacy, more prevalent concerns had more to do with device type, the presence of a citrate, or the color of the product.

Patients’ and families’ altruism, and their willingness to accept a switch for the greater good of the healthcare system, was also a notable finding.

In order to help alleviate concerns, say the authors, all members of the medical team should receive adequate biosimilar education, patients should receive written and verbal education before a switch, families should receive disease- and medication-specific information, and team members should give patients and their families detailed information on the practical aspects of the biosimilar, including information on device types.

Reference

Renton WD, Leveret H, Guly C, Smee H, Leveret J, Ramanan AV. Same but different? A thematic analysis on adalimumab biosimilar switching among patients with juvenile idiopathic arthritis [published online October 4, 2019]. Pediatr Rheumatol. doi: 10.1186/s12969-019-0366-x.