A Switch to Biosimilar Etanercept Yields Mixed Results In Two UK Hospital Systems

The advent of biosimilar etanercept, Benepali, in the United Kingdom has provided a significant opportunity for cost savings, given the biosimilar’s lower price than the reference Enbrel. As such, hospitals have been undertaking nonmedical switches to the biosimilar in order to benefit from these savings. During the British Society for Rheumatology 2018 Annual Conference, held in May in Liverpool, United Kingdom, investigators reported on the results of these switches, both on the financial wellbeing of the health system and on patients.

Read more about nonmedical switching.

In the Dudley Group of Hospitals, report investigators, the rheumatology team negotiated with commissioners to share in the cost savings produced by a switch to the biosimilar from the reference etanercept.¹ In total, 160 of the 194 patients receiving etanercept were switched, and the first 50 patients who undertook the switch were followed up for 6 months as part of an audit.

The 50 patients audited included 32 patients with rheumatoid arthritis (RA), 15 patients with ankylosing spondylitis (AS), and 3 patients with psoriatic arthritis (PsA). The investigators found no clinically significant change in disease activity score in a count of 28 joints in the patients with RA, or in the Bath AS Disease Activity Index in patients with AS. Among the 3 patients with PsA, 2 had no change in symptoms, and 1 showed improvement in tender and swollen joint count.

At 6 months after switching, 84% of patients continued on the biosimilar. Of those who discontinued, 4 stopped after an adverse event, 3 discontinued treatment for inefficacy, and 1 discontinued after developing a contraindication.

Switching to the biosimilar led to a potential annual savings of £660,000 (approximately $855,400), which the department used to fund additional staff. “Our audit found Benepali to be as safe and effective as Enbrel and has demonstrated a positive experience with biosimilar switching,” wrote the authors.

However, in another area of the United Kingdom, investigators report that “a significant proportion of patients” failed a switch to the biosimilar.²

In Croyden Health Services, 168 patients were switched to biosimilar etanercept, producing a savings for the system of £200,000 (approximately $256,872).

However, of those who switched, 11% (n = 18) have switched back to the reference product. The reasons for switching were lack of efficacy (7%) and intolerance (4%). Painful injections, injection-site reactions, and headache were most commonly reported. Among those who switched back to the originator drug because of loss of efficacy, 92% have shown improvement after 3 months.

“These results demonstrate the complexity of biologic therapies and the need for careful assessment and monitoring of those patients switched from an originator biologic to a biosimilar,” concluded the investigators.

References

1. Ma J, Petford S, Jones L, Douglas K, John H. Audit of the clinical efficacy and safety of etanercept biosimilar to its reference product in patients with inflammatory arthritis: experience from a district general hospital in the United Kingdom [published online April 25, 2018]. Rheumatology. doi: 10.1093/rheumatology/key075.288.

2. Patel D, JA Tazeen, Levy S, Rajak R, Sathananthan R, Horwood N. Analysis of rheumatoid arthritis patients who failed the switch from originator etanercept to biosimilar etanercept in Croydon [published online April 25, 2018]. Rheumatology. doi: 10.1093/rheumatology/key075.596.