Lessons Learned From Nonmedical Switching

As more biosimilars are poised to become available to US patients, American rheumatologists are looking to their European counterparts for lessons learned from nonmedical switches from reference products to biosimilars. During the American College of Rheumatology (ACR) Annual Meeting in Chicago, Illinois, which will be held from October 19-24, 2018, several research teams will present on nonmedical switching in the European context.

Investigators from Portugal will report on their survey of 51 physicians in public and private practice, as well as 22 patients with inflammatory diseases who were subject to a switch, on the topic of nonmedical switching to a biosimilar.¹

Among the physicians, 100% said that they were “reasonably informed” about biosimilars, and 61% said that they were familiar with prescribing biosimilars. However, 49% said that they had only a mild to moderate degree of confidence in switching patients to biosimilars.

Among patients, 68% said that they were “reasonably” informed about biosimilars. Patients’ main concerns about a nonmedical switch were safety (50%) and efficacy (27%). Ten of the 22 patients said they had accepted the switch to a biosimilar “without apprehension,” while the remaining patients said that they felt they had no choice in the matter. Eleven of the patients said that they believed the switch was undertaken for cost reasons. Most of the patients did not report a change in their degree of satisfaction with their treatment.

The investigators say that their findings show that, while patients’ satisfaction with biologic therapy is not impacted by a switch to a biosimilar, physicians remain cautious about transitioning to biosimilars.

A second study from Portugal evaluated a switch from reference etanercept to a biosimilar in a single tertiary rheumatology center.² In this center, 98 patients with a variety of rheumatic diseases were treated with etanercept, and 89 of them were switched to a biosimilar.

In the patients who switched, disease activity remained stable over the 3-month follow-up period, with no statistically significant differences observed in acute phase reactants, or in patient or physician global assessment of disease activity before or after the switch. Minor adverse events were reported by 2 patients, and 2 patients reported minor infections. In total, 93% of patients reported that they adapted well to the biosimilar’s delivery device.

The investigators concluded that a nonmedical switch in this group did not affect efficacy or safety of treatment at 3 months.

Alongside safety and efficacy of nonmedical switches, costs are also a primary concern for health systems, and another study sought to estimate the cost impact of a nonmedical switch from reference etanercept to a biosimilar in patients with rheumatoid arthritis (RA) in the United Kingdom.³

In this study, a cohort-based decision tree model was developed with a 1-year time horizon. The model population included patients with RA that was stable with etanercept treatment. Data on switching, baseline healthcare resource use, and the impact of switching on resource use was derived from 150 rheumatologists in 5 EU nations, and data on costs were sourced from the United Kingdom.

The model assumed that 5000 patients were treated with reference etanercept, and that 1259 switched to a biosimilar, either SB4 or GP2015. After 3 months, 26.3% switched again, either back to the reference, to another biosimilar etanercept, or to a different biologic.

In this model, the annual per-patient cost of continuous treatment with the reference etanercept was £12,742 (approximately $16,835), versus £8528 (approximately $11,267) and £8365 ($11,052), respectively, for SB4 and GP2015 treatment.

However, switching increased overall annual healthcare costs;switching from the reference to GP2015 or SB4 resulted in a mean impact of £1120 (approximately $1480) and £1283 (approximately $1695), respectively. Even greater costs were incurred with a switch to a different biologic after using the biosimilar, the authors noted.

References

1. Marona J, Manica SR, Lopes C, et al. Non-medical switch to biosimilars: what have we learned? Presented at the American College of Rheumatology 2018 meeting, October 19-24, 2018; Chicago, Illinois. Abstract 220. https://acrabstracts.org/abstract/non-medical-switch-to-biosimilars-what-have-we-learned/.

2. Brites L, Costa F, Freitas J, et al. Impact of block switch to biosimilar etanercept in practice, across different rheumatic diseases. Presented at the American College of Rheumatology 2018 meeting, October 19-24, 2018; Chicago, Illinois. Abstract 2534. https://acrabstracts.org/abstract/impact-of-block-switch-to-biosimilar-etanercept-in-practice-accross-different-rheumatic-diseases/.

3. Onishchenko K, Alexopoulos ST, Curiale C, Tarallo M. Costs associated with non-medical switching from originator to biosimilar etanercept in patients with rheumatoid arthritis in the UK. Presented at the American College of Rheumatology 2018 meeting, October 19-24, 2018; Chicago, Illinois. Abstract 2994. https://acrabstracts.org/abstract/costs-associated-with-non-medical-switching-from-originator-to-biosimilar-etanercept-in-patients-with-rheumatoid-arthritis-in-the-uk/.