Study Documents HCPs’ Experiences of a Mandatory Switch to Inform Future Transitions

Although no issues with clinical outcomes for patients were reported, the mandatory switch from reference adalimumab to adalimumab biosimilars did result in more administrative work for HCPs.

A survey study explored the experiences of health care providers throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in New Zealand—also known as Aotearoa in the Māori language—in 2022.

Overall, respondents reported they experienced an increase in workload and their satisfaction was “low.” The authors said their findings could inform future transitions, which should ensure training for the biosimilar device, a high-quality patient support program, and a functional authorization process.

Health care systems switch patients to biosimilars to reduce drug costs, but the transition period requires HCPs to navigate new procedures and educate their patients. According to the authors, previous studies have explored the perspectives and opinions of HCPs on biosimilars. However, how a mandatory switch process impacts providers has not been studied.

Approximately 6400 patients in Aotearoa New Zealand being treated for immune-mediated inflammatory diseases with reference adalimumab were switched to an adalimumab biosimilar between March 2022 and September 2022. The researchers surveyed 39 rheumatologists, 16 rheumatology nurses, and 109 pharmacists about their experiences during the transition, including logistics, information and education, support, and administrative workload. About 30% of the HCPs had been previously involved in a switch to a biosimilar, and about 40% had 5 to 10 years of experience with the reference product.

Overall, on a scale of 0 to 10, the mean (SD) satisfaction score was 5.7 (2.6). The aspects of the transition providers were least satisfied with (mean scores < 5) were training for the biosimilar device, information received from government agencies, and administrative workload. The highest satisfaction scores were found for the supply of the biosimilar, how early providers were informed prior to the switch, and their ability to receive information about the biosimilar (mean scores range, 5.7-7.1). Based on the responses, participants were significantly less satisfied with the biosimilar compared to the reference product in terms of safety, efficacy, and quality of the device, as well as availability of alcohol wipes, sharps bins, and the patient support program.

Using a regression model, the researchers found that administrative workload and training for the biosimilar device were the aspects of the transition most strongly associated with overall satisfaction with the transition.

Nearly half (46%) of HCPs reported needing to provide additional education and counseling to patients, teaching patients to use the biosimilar device, and addressing the concerns of patients about switching from their current medication. One-third (33%) of participants also reported that the initial authorization process increased their workload (33%). Increased workload included contacting other providers to correct errors, double-checking authorization numbers, and educating patients. Nurses and pharmacists reported that general practitioners often did not discuss the switch with their patients, leading them to have more responsibility for patient education.

Providers’ reports of what did and did not go well during the transition suggested that rheumatologists and nurses overall thought the biosimilar device (an injection pen) was easier for patients to use, and that the citrate-free buffer reduced injection pain, both of which helped patients’ acceptance of the switch. Providers appreciated the longer duration of approvals for patients following the switch, patients automatically receiving new authorization numbers, and written material they received about the biosimilars.

However, the initial authorization process was poorly implemented, according to survey respondents. They reported that authorization numbers were often attached to the wrong brand, leading to dispensing errors.

Importantly, many providers noted in their responses that the loss of the patient support program provided for the reference product complicated the transition. The authors commented that this increased the demands on providers’ time and resources, and could also negatively affect patient outcomes by leaving patients’ concerns unaddressed or by reinforcing negative perceptions they may have about the lower-cost biosimilar.

The researchers said their findings “demonstrate the importance of ensuring the biosimilar brand package is comparable with the originator and that the administrative and educational process is simple for all health care providers involved.” They stressed the importance of learning from providers’ experiences of biosimilar switches to understand how to streamline the process and minimize the added workload. Following a mandatory switch, they said, patient care must be delivered equivalent to that provided for the reference product.

Reference

Gasteiger C, Lobo M, Wong LS, Murdoch R, Dalbeth N. Health care providers' experiences of a mandatory nationwide transition to an adalimumab biosimilar. ACR Open Rheumatol. Published online October 1, 2023. doi:10.1002/acr2.11617