Ab0250 real-World Outcomes in Stable Originator Biologic-Treated Adult Patients Who Stayed on the Therapy Versus Those Who Switched to Biosimilar: A Retrospective Chart Review Study in Europe

Abstract

BackgroundBiologic therapies have considerably improved clinical management of autoimmune diseases. Over the past few years, several biosimilars have been introduced in Europe for these conditions. Limited information is available evaluating the impact of switching stable patients from originators to their respective biosimilars in clinical practice for non-medical reasons.ObjectivesThis real-world study reported and compared patient characteristics, clinical outcomes, and healthcare resource utilization (HRU) associated with stable patients who switched from the originator biologic etanercept to its biosimilar (switchers) vs. those who stayed on the originator (non-switchers) in adults with a rheumatic condition such as ankylosing spondylitis (AS), psoriatic arthritis (PsA), or rheumatoid arthritis (RA).MethodsMedical record data were retrospectively collected anonymously from rheumatologists in the UK and Germany. Adult patients who were diagnosed with RA, AS, or PsA, treated with originator etanercept for at least 6 months with a stable dosing schedule, and had no emergency department visit or hospitalization for the disease of interest over the 6-month period were eligible for the study. The index date for a non-switcher was the prescription date closest to one year after the initiation of originator etanercept and with a stable dosing for at least 6 months. The index date for a switcher was the biosimilar initiation date. Chart data available for at least 12 months prior to and post the index date were required. Patient characteristics, disease severity, symptoms and signs, and HRU were extracted anonymously. Unadjusted and adjusted comparisons of the outcomes between non-switchers and switchers were conducted among all patients and for each individual disease.ResultsData were extracted from 242 patient records (non-switchers = 123, 50.8%; switchers = 119, 49.2%; AS=26.4%; PsA=26.0%; RA=47.5%) from 162 rheumatologists. At baseline, non-switchers were significantly younger than switchers (44.5 vs. 48.4 years, p<0.05), had a significantly shorter time on the originator etanercept (11.7 vs. 23.8 months), and more patients had been treated with NSAIDS (55.3% vs. 37.8%). Significantly more non-switchers had moderate, or severe disease (27.6% vs 16.0%, p<0.05; 26.8% vs 5.9%, p<0.01) and non-switchers on average had worse joint or spine pain (4.4 vs 2.4, p <0.01) than switchers. During the follow-up period, significantly more non-switchers’ disease status improved (58.5% vs. 25.2%. p<0.01), resulting comparable disease severity (moderate: 10.6% vs 10.9%; severe: 0% vs 0%) and joint or spine pain scale (2.0 vs 1.0) between the two cohorts. After adjusting for potential confounding factors, compared to switchers, more AS and PsA non-switchers improved in disease severity (AS: p<0.05; PsA: p<0.01), and RA non-switchers had a fewer number of swollen joints (0.5 vs 1.5, p<0.01). Non-switchers generally had numerically lower HRU than switchers during the one-year follow-up period (patients with outpatient visits: 76.4% vs...

The Economic Impact of Originator-to-Biosimilar Non-medical Switching in the Real-World Setting: A Systematic Literature Review

“…It was found that, in comparison to non-switchers, patients who switched to the biosimilar experienced an increase in the number of various services at both 0–3 months and 4–6 months post-switch, which included blood tests, x-rays, ultrasounds, ER visits, specialist visits, and hospitalizations [ 32 ]. In line with these results, the studies by Gibofsky et al (2019) and Glintborg et al (2018) also found an increase, although marginal, in the number of outpatient visits post-NMS for rheumatology patients, including RA, psoriatic arthritis, and axial spondylarthritis [ 33 , 34 ]. The difference in outpatient visits for patients with rheumatic disease associated with NMS was greater in the study by Tarallo et al (an increase ranging from 0.18 to 0.70 over 3 months) in comparison to both Gibofsky et al and Glintborg et al (an increase of 0.2 over 3 months and 0.01 at 6 months post-switch vs 6 months pre-switch, respectively) [32 – 34 ].…”

“…In line with these results, the studies by Gibofsky et al (2019) and Glintborg et al (2018) also found an increase, although marginal, in the number of outpatient visits post-NMS for rheumatology patients, including RA, psoriatic arthritis, and axial spondylarthritis [ 33 , 34 ]. The difference in outpatient visits for patients with rheumatic disease associated with NMS was greater in the study by Tarallo et al (an increase ranging from 0.18 to 0.70 over 3 months) in comparison to both Gibofsky et al and Glintborg et al (an increase of 0.2 over 3 months and 0.01 at 6 months post-switch vs 6 months pre-switch, respectively) [32 – 34 ]. Once again similar to Tarallo et al, the study by Glintborg et al (2018) reported a significant increase in the utilization of various healthcare resources, albeit different resources than those reported in Tarallo et al (2019), following infliximab NMS [ 33 ].…”

“…While these studies were scarce, they provided a better understanding of the savings or costs that were associated with the switch from the reference biologic to the biosimilar drug. Specifically, three studies reported on HCRU differences [6,33,34], three studies reported on cost differences [35][36][37], and one study reported on differences in both HCRU and overall costs [32]. With regards to HCRU, all studies concluded that NMS was associated with a significant or numerical increase in HCRU among patients who underwent originator-tobiosimilar NMS [6,[32][33][34].…”

“…Specifically, three studies reported on HCRU differences [6,33,34], three studies reported on cost differences [35][36][37], and one study reported on differences in both HCRU and overall costs [32]. With regards to HCRU, all studies concluded that NMS was associated with a significant or numerical increase in HCRU among patients who underwent originator-tobiosimilar NMS [6,[32][33][34]. Interestingly, there was a notable difference between studies in terms of outpatient visits associated with NMS, where this was greater for the study by Tarallo et 2017) found that a NMS from originator etanercept or infliximab to the biosimilar in rheumatic patients generated an overall increase in total costs to patients in comparison to remaining on the originator (p = 0.046 in Phillips (2017), unreported in Peral (2018) and Tarallo (2019)) [32,36,37].…”

“…Interestingly, all four of these studies reported an increase in HCRU with originator-to-biosimilar NMS, three of which were focused on rheumatology and the other on oncology. More specifically, they found that NMS can be associated with increased medical visits, medical services such as imaging, phone consultations, and emergency room (ER) visits, in addition to hospitalizations [6,[32][33][34].…”