Rheumatology practices should provide written and verbal patient education, and supply adequate teaching for all staff, prior to nonmedical biosimilar switching for patients with juvenile idiopathic arthritis, according to recommendations published in Pediatric Rheumatology.
“Experience among adults suggests that the uptake of biosimilars in open label environments is hindered when compared to blinded trials,” William D. Renton, of the Bristol Royal Hospital for Children, U.K., and colleagues wrote. “These ‘failed switches’ are usually attributed to subjective reports of perceived decrease in efficacy or non-specific drug effects. These are thought to largely be due to the nocebo effect; noxious reactions to therapeutic interventions that occur because of negative expectations of the patient.”
“Emerging pediatric data, while scarce, suggests that some children also unsuccessfully switch,” they added. “The implications of failed switching could potentially include exhaustion of therapeutic options, unnecessary exposure to other medications, increased health care utilization, worse patient outcomes and higher overall health care costs.”
To analyze the perceptions of juvenile patients and their guardians regarding biosimilar switching, Renton and colleagues interviewed nine families recruited from the pediatric rheumatology outpatient clinics at the Bristol Children’s Hospital and Bristol Eye Hospital. All patients were younger than 18 years, with a diagnosis of JIA, who were receiving adalimumab (Humira, AbbVie). The researchers conducted the study prior to a trust-wide mandatory change from the adalimumab originator drug to a biosimilar, based on guidance from the National Health Service.
Rheumatology practices should provide written and verbal patient education, and supply adequate teaching for all staff, prior to nonmedical biosimilar switching for patients with juvenile idiopathic arthritis, according to recommendations.
Patients and families participated in semi-structured interviews, either by telephone or in a private setting during clinical appointments. Each family was interviewed once, with questions directed to patients and guardians alike. Interviews were recorded on audio tape and transcribed, with the notes used to identify and develop themes.
According to the researchers, the comments and responses from each of the surveyed families led to the development of five main themes regarding their perceptions on biosimilar switching. These include drug administration, concerns, benefits, equivalence, and trust in treating clinicians. The researchers later used these themes to draft a series of seven recommendations for nonmedical biosimilar switching for pediatric patients:
- Proper biosimilar education and training for all practice staff;
- All members of the practice staff should convey a coherent message regarding biosimilars;
- Patients should receive written and verbal education on biosimilars prior to switching;
- Information provided to families should be specific to the patient’s disease and medication;
- Practice staff should use positive framing when discussing biosimilars while remaining honest and balanced;
- Staff should provide patients and families with detailed information on the practical details of biosimilar use, including device types, delivery logistics and additives; and
- Treatment information should be written and endorsed by a medical team that is familiar with the family, rather than an anonymous pharmacy or administrator.
“It’s known that clinicians often disagree with nonmedical switching and feel that patients should be given a choice,” Renton and colleagues wrote. “Nonetheless, it is important to portray a positive message despite any clinician opinions and biases. We have outlined recommendations on the basis of existing adult literature and the observations from this study.”
“With significant financial strain across many health care settings, nonmedical biosimilar switching is likely to be an increasingly frequent occurrence,” they added. “We hope that the findings and recommendations from this study may help clinicians assist their patients through this process.” – by Jason Laday
Disclosure: The researchers report no relevant financial disclosures.