Originator Etanercept Research Articles

AB0217 NON MEDICAL SWITCH FROM ETANERCEPT ORIGINATOR TO BIOSIMILAR GP2015 IN PATIENTS WITH CHRONIC INFLAMMATORY ARTHROPATHIES

Background:In the last decades, new biologic drugs were introduced for the treatment of chronic inflammatory arthropathies, progressively leading to a relevant increase of medical costs. However, the introduction of biosimilars (biologic molecules similar to branded drugs with expired patent) permitted to optimize the financial resources. The non-medical switch (NMS) is the switch from a biologic originator to a biosimilar agent for economic reasons only, on the basis of the substantial equivalence as regards efficacy and safety between originator and biosimilar drugs.In literature, several evidences from clinical trials and registry studies showed that the switch from etanercept originator to biosimilar SB4 was safe [1]. Instead no sufficient data may be found regarding the biosimilar GP2015.Objectives:We aimed to evaluate efficacy, safety, and retention rate in a series of patients with chronic arthritis treated with etanercept originator who underwent to NMS towards the ETN biosimilar GP2015.Methods:From March to June 2020, all patient referred in our Centre affected by rheumatoid arthritis (RA), psoriatic arthritis (PA) and axial spondyloarthritis (axSpA) treated with etanercept originator and in remission/low disease activity for at least 6 months underwent to NMS. Data on disease activity (DAS28-PCR/CDAI/SDAI; DAPSA; BASDAI), eventual adverse events and causes of withdrawal of therapy were collected at 2, 4 and 6 months after the switch.Results:We recruited 71 consecutive patients (M/F: 24/47; mean age 55,8± 11,1 years; 39 RA; 15 PA; 17 axSpA; mean duration therapy 7.3±3.8 years). Disease activity was unchanged for almost all patients after 6 months from the switch (median ΔDAS28-PCR/CDAI/SDAI: 0,1/0/0,5; median ΔDAPSA: 0; median ΔBASDAI: 0) Moreover, the 6-month retention rate was 97.2%. Only 2 patients (2.8%) switched back to the originator due to loss of efficacy in one case and adverse events in the second case (paraesthesia, headache, dizziness and worsening of arthralgia).Conclusion:Our study confirmed that the NMS from ETN originator to GP2015 represents a safe practice that maintains the efficacy of the current treatment.

Efficacy, Safety, and Immunogenicity of Biosimilar Etanercept (Enerceptan) Versus Its Original Form in Combination With Methotrexate in Patients With Rheumatoid Arthritis: A Randomized, Multicenter, Evaluator-Blinded, Noninferiority Study.

Enerceptan (EtaBS) has been developed as a proposed biosimilar of etanercept. This randomized, multicenter, evaluator-blinded, noninferiority study conducted in Argentina included adults with active, moderate, and severe rheumatoid arthritis with inadequate response to methotrexate. Subjects were randomly assigned to 32 weeks treatment with EtaBS (n = 99) or etanercept (n = 51) at a weekly 50-mg dose administered subcutaneously. Patients were categorized according to prior use of biologic disease-modifying antirheumatic drugs and concomitant use of steroids. The primary efficacy endpoint was ACR20 response rate at week 32. Safety, immunogenicity, and steady-state concentration of both drugs were evaluated. The noninferiority margin for ACR20 was estimated at 12%. In the per-protocol population, 85 subjects (92.4%) treated with EtaBS and 44 subjects (93.6%) treated with etanercept achieved ACR20 (difference, -1.2%; 95% confidence interval, -10.1% to 7.6%). Frequent adverse drug reactions occurred in 34.3% and 38% of subjects treated with EtaBS and etanercept, respectively. The most common reaction was upper respiratory tract infection. Six and 3 serious adverse events occurred in 4 and 3 subjects treated with EtaBS and etanercept, respectively. Injection site reactions occurred in 67.7% and 66.0% of subjects treated with EtaBS and etanercept, respectively. Two subjects treated with EtaBS and 1 subject treated with etanercept developed antibodies by week 32. Efficacy outcomes for EtaBS were noninferior to original etanercept in patients with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate. Safety and immunogenicity results were comparable between the two. This study is a major step toward improving access to biologics in Latin America.

A Look at the History of Biosimilar Adoption: Characteristics of Early and Late Adopters of Infliximab and Etanercept Biosimilars in Subregions of England, Scotland and Wales - A Mixed Methods Study.

BackgroundRegions within England, Scotland and Wales show variation in rate of adoption of biosimilar infliximab and etanercept.ObjectivesThis study aims to examine how local decisions and practices in regions within England, Scotland and Wales might explain initial variation in market dynamics of biosimilar and originator infliximab and etanercept.MethodsMarket data provided by the National Health Service (NHS) on biosimilar and originator infliximab and etanercept uptake were analysed for the 10 historical regions of England, 14 health boards in Scotland and 7 health boards in Wales (2015–2018). Findings were discussed in ten semi-structured interviews: on a national level with an industry representative (1), on a regional level with NHS employees in England (6), Scotland (1) and Wales (1), and on a local level with a representative of a clinical commissioning group in England (1).ResultsTenders for infliximab and etanercept in England, Scotland and Wales have consistently resulted in a biosimilar as the best value biological. Early and late biosimilar adopters are seen, with overall convergence towards high biosimilar market shares over time. Qualitative results suggest that biosimilar adoption was positively influenced by (a) a price difference between biosimilar and originator product making it worthwhile to switch patients; (b) a good relationship between commissioner and provider in England resulting in gain share agreements; (c) leadership on biosimilars in regional NHS offices in England or Scottish and Welsh health boards; (d) key opinion leaders or leading hospitals that start using biosimilars early and gain experience.ConclusionsThis study has shown that the savings potential drives biosimilar use. Regions with a proactive attitude, good stakeholder relationships, and clinician engagement were identified as early adopters.

Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany.

Drug budget and prescription control measures are implemented regionally in Germany, meaning that the uptake of pharmaceuticals, including biosimilars, can vary by region. We examine regional market dynamics of tumor necrosis factor alpha (TNFα) inhibitor originators and biosimilars in Germany and studied the influence of biosimilar policies on these dynamics. This study is based on: (1) a literature review in which German biosimilar policies are identified, (2) the analysis of dispensing data (2010–2018) for the class of TNFα inhibitors, and (3) ten semi-structured interviews investigating prescribers’ and insurers’ views on factors potentially influencing biosimilar uptake. The analysis of biosimilar market shares of infliximab and etanercept revealed wide variations across the 17 German Regional Associations of Statutory Health Insurance Accredited Physicians (PA regions). Quantitative analyses indicated that biosimilar market shares for infliximab and etanercept were significantly lower in former East Germany when compared to former West Germany regions. Through qualitative interview analyses, this study showed that the use of infliximab and etanercept biosimilars across Germany is primarily influenced by (1) the regional-level implementation of biosimilar quotas and the presence of monitoring/sanctioning mechanisms to ensure adherence to these quotas, (2) the different insurer-manufacturer discount contracts, and (3) gainsharing arrangements established at the insurer-prescriber level.

Efficacy and safety of a single switch from etanercept originator to etanercept biosimilar in a cohort of inflammatory arthritis

AntiTNF-α biosimilars are broadly available for the treatment of inflammatory arthritis. There are a lot of data concerning the maintenance of clinical efficacy after switching from originators to biosimilars; therefore, such a transition is increasingly encouraged both in the US and Europe. However, there are reports about flares and adverse events (AE) as a non-medical switch remains controversial due to ethical and clinical implications (efficacy, safety, tolerability). The aim of our work was to evaluate the disease activity trend after switching from etanercept originator (oETA-Enbrel) to its biosimilar (bETA-SP4/Benepali) in a cohort of patients in Turin, Piedmont, Italy. In this area, the switch to biosimilars is stalwartly encouraged. We switched 87 patients who were in a clinical state of stability from oETA to bETA: 48 patients were affected by Rheumatoid Arthritis (RA),26 by Psoriatic Arthritis (PsA) and 13 by Ankylosing Spondylitis (AS).We evaluated VAS-pain, Global-Health, CRP, number of swollen and tender joints, Disease Activity Score on 28 joints (DAS28) for RA, Disease Activity in Psoriatic Arthritis (DAPSA) for PsA, Health Assessment Questionnaire (HAQ) and Health Assessment Questionnaire for the spondyloarthropathies (HAQ-S),Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients. 11/85 patients (12.6%) stopped treatment after switching to biosimilar etanercept. No difference was found between oETA and bETA in terms of efficacy. However, some arthritis flare and AE were reported. Our data regarding maintenance of efficacy and percentage of discontinuation were in line with the existing literature.

One-year results after transitioning from etanercept originator to biosimilar in a setting promoting shared decision-making in rheumatology.

ObjectiveThe aim was to study the effect of non-mandatory transitioning from etanercept originator to etanercept biosimilar on retention rates in a setting promoting shared decision-making.MethodsIn 2016, all patients treated with etanercept originator and stable disease at the Rheumatology department in Bernhoven were offered transitioning to etanercept biosimilar by an opt-in approach. A historical cohort of patients treated with etanercept originator in 2015 was identified as the control group. Etanercept discontinuation was compared between the cohorts using Cox regression. To study the nocebo effect, reasons for discontinuation were categorized into objective reasons (e.g. laboratory abnormalities, increase in swollen joint count, allergic reaction) and subjective health complaints (symptoms perceptible only to the patient, e.g. tiredness, arthralgia). An adjusted Kaplan–Meier curve for retention of the etanercept biosimilar was made, censoring subjective health complaints as the reason for discontinuation.ResultsSeventy of the 79 patients eligible for transitioning agreed to transition (89%). The 1-year crude retention rate of etanercept in the transition cohort was 73% (95% CI: 0.62, 0.83), compared with a retention rate of 89% (95% CI: 0.81, 0.95) in the historical cohort (P = 0.013). This resulted in a higher risk of treatment discontinuation in the transition cohort (adjusted hazard ratio = 2.73; 95% CI: 1.23, 6.05, P = 0.01). After adjusting for the nocebo effect, the cohorts had comparable retention rates (86 vs 89%, P = 0.51).ConclusionNon-mandatory transition from etanercept originator to its biosimilar using an opt-in approach in a setting promoting shared decision-making resulted in a higher discontinuation of etanercept compared with the historical cohort. This could be attributed largely to the nocebo effect.

AB0292 EFFICACY AND SAFETY OF TWO BIOSIMILAR ETANERCEPT AFTER THE SWITCH FROM THEIR CORRESPONDING ORIGINATOR IN THE TREATMENT OF PATIENTS WITH AUTOIMMUNE ARTHRITIS; A RETROSPECTIVE ANALYSIS IN A REAL LIFE SETTING

Background:The available biosimilars of etanercept are as effective and well tolerated as their bio originator molecule in the naive treatment of chronic autoimmune arthritis. More data about the switching from the bio originator are needed.Objectives:To compare the clinical outcomes of the treatment with etanercept biosimilars (SB4 and GP2015) naïve and after the switch from their corresponding originator in patients affected by autoimmune arthritis in a real life settingMethods:We retrospectively analyzed the baseline characteristics and the retention rate in a cohort of patients who received at least a course of etanercept (originator or biosimilar) in our Rheumatology Units from January 2000 to January 2020. We stratified the study population according to biosimilar use. Descriptive data are presented by medians (interquartile range [IQR]) for continuous data or as numbers (percentages) for categorical data. Drug survival distribution curves were computed by the Kaplan-Meier method and compared by a stratified log-rank test. A Cox proportional hazards regression analysis stratified by indication, drug, age, disease duration, sex, treatment line, biosimilar use and prescription year was performed. P values≤0.05 were considered statistically significant.Results:477 patients (65% female, median age 56 [46-75] years, median disease duration 97 [40.25-178.75] months) treated with etanercept were included in the analysis. 257 (53.9%) were affect by rheumatoid arthritis, 139 (29.1%) by psoriatic arthritis, and 81 (17%) by axial spondylarthritis. 298 (62.5%) were treated with etanercept originator, 97 (20.3%) with SB4, and 82 (17.2%) with GP2015. Among the biosimilars 90/179 (50.3%) patients were naïve to etanercept treatment. Among the 89 switchers we observed 8 treatment discontinuations: one due to surgical infection complication, three due to disease flare, two due to subjective worsening and one due to remission. The overall 6- and 12-month retentions rate were 92.8% and 80.2%. The 6- and 12-month retention rate for etanercept, SB4 and GP2015 were 92.7%, 93.4% and 90.2%, and 82%, 74.5% and 88.1% respectively, without significant differences among the three groups (p=0.374). Patients switching from originator to biosimilars showed and overall higher treatment survival when compared to naive (12-month retention rate 81.2% vs 70.8%, p=0.036). The Cox proportional hazard regression analysis highlighted that the only predictor significantly associated with an overall higher risk of treatment discontinuation was the year of prescription (HR 1.08, 95% CI 1.04 to 1.13; p<0.0001).Conclusion:In our retrospective study etanercept originator and its biosimilars (SB4 and GP2015) showed the same effectiveness. Patients switching from originator to biosimilar showed an significant higher retention rate when compared to naive. The only predictor of treatment discontinuation highlighted by the Cox proportional hazard regression analysis was the year of treatment prescription.Disclosure of Interests:Francesco Girelli: None declared, Alarico Ariani: None declared, Marco Bruschi: None declared, Andrea Becciolini Speakers bureau: Sanofi-Genzyme, UCB and AbbVie, Lucia Gardelli: None declared, Maurizio Nizzoli: None declared

AB1196 A STUDY REVIEWING THE ASSOCIATED FACTORS AND COST-EVALUATION OF SWITCHING BACK TO ORIGINATOR-ETANERCEPT FROM ITS BIOSIMILAR AMONG PATIENTS WITH RHEUMATIC DISORDERS AT A TERTIARY CARE CENTRE IN UNITED KINGDOM

Background:Biological therapy plays a major role in the management of patients with rheumatic disorders. Evidences generated at experimental settings have shown biosimilars as clinically effective, safe and cost effective. Nevertheless, real world data are lacking about cost effectiveness and causes of switching back to originator product among patientsObjectives:To describe the associated factors and cost evaluation of switching back to the originator etanercept from the biosimilar among patients with rheumatic disorders at The Robert Jones and Agnes Hunt Orthopaedic Hospital of United KingdomMethods:A descriptive cross-sectional study was undertaken with secondary data in a tertiary care hospital. All the patients who were switched from original etanercept (originator) to biosimilar Etanercept from October 2018 to June 2019 were included in the study. A pre-tested data extraction sheet was used in the data collection. Annual expenditure estimates for the treatment modalities were collected by consulting the experts. Descriptive analysis was done for the characteristics of the study sample and for the estimated annual costs. Associations of age and sex in the switching of treatment modalities were explored with chi-square test and Mann Whitney U test with 5% significance level.Results:Records of 100 participants were extracted with a male to female ratio of 1: 1.4. The median [interquartile range (IQR)] of the participants was 54 (44 to 66) years. The leading three diagnoses were: rheumatoid arthritis (65%), Ankylosing Spondylitis (18%) and Psoriatic arthritis (14%). Out of the participants, 32 (32%) switched back to originator with a median (IQR) duration of 16.0 (10.5 to 19.5) weeks of commencing the biosimilar. The proportions of switching back were 28.1%, 34.4% and 37.5% among those who did, in the chronological 3- monthly intervals of the study. The main reasons for switching back included; side effects (21.9%), lack of efficacy (65.6%), both of these (9.4%) and other reasons (3.1%). Older age was observed among those who switched back (p<0.05) but gender did not show a statistically significant association (p=0.532). The annual estimated cost for biosimilar was 37.3% less than that for originator per patient.Conclusion:In our cohort nearly one third switched back to the originator following the commencement of biosimilar incurring a financial and resource burden to the rheumatology department which in turn will have wider ramifications on the health care system. Exploring the reasons and factors associated with switching back to the originator in larger scale studies would help in planning cost-effective interventions and understanding the reasons why the patients revert back to the originator from the biosimilar therapy, especially among the older patients.

Rapid monitoring of health services utilization following a shift in coverage from brand name to biosimilar drugs in British Columbia—An interim report

We explored changes in health services utilization associated with the Biosimilars Initiative introduced in British Columbia on May 27, 2019. To maintain drug coverage, the policy requires users of originator infliximab or etanercept to transition to biosimilar versions. We present a three-month interim analysis of this initiative. We conducted a rapid monitoring analysis to evaluate changes in health services utilization three months after the policy was introduced compared with a three-year period before the policy's introduction. Using the administrative claims data of the British Columbia Ministry of Health, we assembled three historical cohorts and one policy cohort of users of each originator drug (8 cohorts in total). Cumulative incidences of medication refills, switching, and visits to physicians were the outcome measures used to compare policy and historical cohorts. Likelihood ratios were used to quantify statistical differences between each policy cohort and its respective historical controls. Likelihood ratios above 7.1 were considered statistically significant. The four infliximab cohorts included 436 patients on average, mean age 56 to 59, 53% to 55% females. The four etanercept cohorts included 1826 patients on average, mean age 57 to 58, 60% to 63% females. Three months after the policy's introduction, 21% of patients treated in the policy cohorts transitioned to the biosimilar versions. Health services utilization in the policy cohorts were consistent with the historical cohorts. An increase in visits to physicians was expected but not detected in the first three months of the Biosimilars Initiative. The impacts of the policy will continue to be monitored.

A rapid monitoring plan following a shift in coverage from brand name to biosimilar drugs for rheumatoid arthritis in British Columbia.

To describe a rapid monitoring plan to assess the impacts of a shift in drug coverage for biosimilar drugs in British Columbia following the introduction of a new policy on 27 May 2019. The Biosimilars Initiative requires users of originator infliximab or etanercept to switch to biosimilar versions of those drugs to maintain coverage. We propose a signal-detection method to provide near-real-time information to policymakers on the impacts of the policy change. The exposure will be the Biosimilars Initiative, a policy affecting patients using originator infliximab (Remicade) and etanercept (Enbrel) for approved rheumatologic or dermatologic indications. Two policy cohorts and six historical control cohorts of patients using originator infliximab or etanercept will be assembled using linked and de-identified data from the British Columbia Ministry of Health. Patients will be identified during the 6-month period before the policy anniversary. Outcomes will include medication refills and switching, hospital admissions, emergency department visits, and physician visits. Summary outcome measures, such as cumulative incidence or average quantity as applicable, will be examined daily and reported monthly for 1 year. Outcomes in the policy cohorts will be compared with historical controls using likelihood ratios. The results of this rapid monitoring plan will be based on analyses involving approximately 9000 patients: four infliximab cohorts of approximately 430 patients and four etanercept cohorts of approximately 1800 patients. Rapid monitoring results will inform ongoing policy decisions related to the Biosimilars Initiative, in terms of impacts on both patient health and health services utilization.

The switch from etanercept originator to SB4: data from a real-life experience on tolerability and persistence on treatment in joint inflammatory diseases.

Aims:Switching from originator to biosimilar is part of current practice in inflammatory rheumatic musculoskeletal diseases (iRMDs) such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondylarthritis (axSpA), with evidences derived from both etanercept (ETN) to SB4-switching randomized controlled trials and real-life registries. We investigated the safety and treatment persistence of ETN/SB4 in a multi-iRMD cohort derived from two rheumatology departments in our region.Methods:Adult patients with iRMDs, treated with ETN for at least 6 months and switched to SB4 in stable clinical condition, were eligible for this retrospective evaluation. Retrospective data on adverse events, loss of efficacy and persistence on treatment were collected until latest available follow-up.Results:A total of 220 patients (85 RA, 81 PsA, 33 axSpA, 14 juvenile idiopathic arthritis and seven other conditions; 142 females, mean age 58 ± 7 years, disease duration 12 ± 4 years, ETN duration 7 ± 4 years) were enrolled, with median follow-up of 12.1 (9.7–15.8) months. A total of 50 patients (22.7%) presented with at least one adverse event, with 36 (16.4%) disease flares and 30 (13.6%: 11 for safety and 19 loss of efficacy) SB4 withdrawals. Cumulative SB4 treatment persistence was 99.1%, 88.6% and 64.6% at 6, 12 and 18 months respectively. Back-switch to ETN was performed in 17/30 cases, the remaining cases were managed with change of biologic disease modifying or conventional synthetic anti-rheumatic drug. Age was the only significant predictor of SB4 interruption at 6 months.Conclusion:Our real-life data confirm the safety profile of switching from ETN to SB4, with slightly higher treatment persistence rates compared with other real-life registries.

Observational study of inflammatory arthritis treatment by etanercept originator switched to an etanercept biosimilar.

ObjectivesThe aim of the study was to assess the safety and efficacy of switching an etanercept originator to an etanercept biosimilar in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis patients.Material and methodsIn 162 patients etanercept originator treatment had been replaced with the biosimilar (Group 1), and in six patients the biosimilar was initiated as the first biological agent (Group 2). The efficacy and safety of the treatment were monitored at 3–6 months.ResultsIn the majority of patients in Group 1 (n = 138) the etanercept biosimilar was well tolerated, whereas in 24 patients a switch back to the originator was required. The loss of efficacy was confirmed in nine patients using clinical scoring system, and nine patients reported subjective loss of efficacy; 13 patients reported adverse events, most often headache (n = 3) and skin lesions (n = 3). In four patients injection site reactions were present. The adverse events (AE) and/or the loss of the biosimilar efficacy were more commonly observed in women, patients with rheumatoid arthritis (especially in those who did not receive methotrexate), and in patients with a previous history of any other biological treatment. In patients in Group 2 the therapy was effective and no adverse events were observed.ConclusionsThe etanercept biosimilar seems to be effective and well-tolerated in the majority of patients. Nevertheless, in some cases, switching from the originator to the biosimilar was associated with AEs or loss of efficacy.

Efficacy and safety of original and biosimilar etanercept (SB4) in active rheumatoid arthritis – A comparison in a real-world national cohort

ObjectiveThe study aims to compare the efficacy and safety of biosimilar etanercept (SB4) to original etanercept (ETN) in a real-life national cohort of rheumatoid arthritis (RA). MethodsData from RA patients were retrieved electronically from the Romanian Registry of Rheumatic Diseases (RRBR), which contains all patients receiving biologics in the country. ResultsThe study included 242 patients with efficacy and safety data after 6 months of treatment: 123 (50.8%) with ETN, 119 (49.2%) with SB4. There were no significant differences after 6 months regarding composite scores of RA activity between patients on ETN and SB4 (e.g. DAS28 remission: 18.7% in ETN group and 17.6% in SB4 group, p = 0.823; Boolean remission: 11.4% in ETN group and 11.8% in SB4 group, p = 0.926). There were 11 adverse events (AE) in the ETN subgroup (including 3 severe AE: lower respiratory tract infection, enterocolitis and anaphylaxis) and 12 AE in SB4 subgroup (including 4 severe AE: lower respiratory tract infection, vasculitis, anaphylaxis and rash). ConclusionBiosimilar and original etanercept showed similar efficacy and safety after the first 6 months of treatment in RA patients from a national registry, which brings further evidence for biosimilarity in unselected patients in real-world setting.

P20 Biosimilar use in children and young people with juvenile idiopathic arthritis in a real-world setting in the United Kingdom

Abstract Background Most research concerning biosimilar use in musculoskeletal diseases has been conducted in adults. Little to no data regarding the use of biosimilars in children and young people with juvenile idiopathic arthritis (JIA) exist. Our aim was to describe the characteristics of children and young people with JIA starting biosimilars in the United Kingdom (UK) with musculoskeletal diseases. Methods The Biologics for Children with Rheumatic Diseases (BCRD) study is an ongoing prospective UK study recruiting children and young people with JIA starting biologic therapies other than etanercept originator (followed in a separate parallel study) from 2010 onwards. Baseline information is collected via questionnaires completed by the treating physician or affiliated clinical research nurse. Follow-up data including disease activity measures and changes in drug therapy are collected at six months, one year and annually thereafter. From May-2015, data has been captured on anti-TNF biosimilars in the UK. Results To 18 June 2019, 159 patients had started a biosimilar; 84 (53%) infliximab (2 products), 60 (38%) etanercept (2 products), and 15 (9%) adalimumab. Of these, 53 (33%) started the biosimilar as their first biologic therapy. Fifty (31%) patients switched from their originator, median (IQR) time on originator before switch was 2.2 (1.1-4.1) years, with most citing cost or hospital policy (n = 22) as the reason and these patients had low disease activity (median active joint count was zero) at point of switch. Fifty-six (35%) patients switched to a biosimilar from a non-originator biologic with 37 (66%) switching for efficacy reasons and 13 (23%) for safety reasons, with higher disease activity reported (median active joint count was three); most (n = 32) switching from adalimumab. Follow-up data was available in 143 patients; median follow-up time was 1.1 (0.7, 1.9) years. Sixty-seven patients switched to another biologic in this period. The majority (n = 38) switched to a non-originator biologic, predominantly adalimumab (n = 22) or tocilizumab (n = 14). Nineteen patients switched between infliximab biosimilars. Ten patients switched to the originator biologic (two due to inefficacy, four due to adverse events, four due to painful injections), although only four of these were on the originator prior to starting biosimilar; overall, in patients who switched from originator to biosimilar, 8% switched back to the originator. Conclusion Biosimilars in children and young people with JIA are being used as both first-line and subsequent-line biologic therapy. Patients starting a biosimilar from an originator product had lower disease activity and reported switching due to cost reasons, whilst patient starting a biosimilar from a non-originator were doing so due to inefficacy. Overall tolerance of biosimilar appears to be good so far, with few patients switching back to the originator. It is imperative that these patients continue to be followed within the registers so that effectiveness and safety of these treatments can be captured. Conflicts of Interest The authors declare no conflicts of interest.

Costs associated with non-medical switching from originator to biosimilar etanercept in patients with rheumatoid arthritis in the UK

Aims: To estimate the cost impact of non-medical switching from originator to biosimilar etanercept in stable patients with rheumatoid arthritis (RA) in the UK.Materials and methods: A cohort-based decision tree model was developed with a 1-year time horizon. The model population included patients with stable RA (patients who responded to originator etanercept treatment with no treatment changes in the previous 6 months). Patients could undergo a non-medical switch to a biosimilar and then switch treatment again, if medically required, after 3–6 months. Data on the proportion of patients switching therapies, baseline healthcare resource use, and impact of switching on resource use were sourced from a survey of 150 rheumatologists from EU5 markets (France, Germany, Italy, Spain, UK). The average impact of switching was evaluated as mean values for change in resource utilization due to switching. Also, low- and high-impact scenarios (lower and upper values of the 95% confidence intervals for change in resource utilization due to switching) were modelled as sensitivity analyses. Cost data came from published UK sources.Results: The model assumed that 5,000 patients were treated with originator etanercept, with 1,259 (25.2%) switching to a biosimilar. Of those, 875 (69.5%) and 384 (30.5%) switched to SB4 and GP2015, respectively. After 3 months, 26.3% of patients who switched treatments did so again: 8.3% back to originator, 3.8% to the other biosimilar, and 14.2% to another biologic. Although originator etanercept was more expensive than the biosimilars, switching was more costly than continuous originator treatment across all impact scenarios. Switching treatment chains had higher overall annual per-patient costs than continuous originator treatment. Switching was associated with increased healthcare resource use.Limitations: Results from this analysis are not transferable to other (non-RA) etanercept indications.Conclusion: Non-medical switching can result in increased payer costs because of increased healthcare resource use following switching.

Does a mandatory non-medical switch from originator to biosimilar etanercept lead to increase in healthcare use and costs? A Danish register-based study of patients with inflammatory arthritis

ObjectivesIn year 2016, Danish national guidelines included a mandatory switch of patients with inflammatory rheumatic diseases treated with originator etanercept (ETA) to biosimilar SB4 in routine care. We aimed to...

Implementing and delivering a successful biosimilar switch programme – the Berkshire West experience

Biosimilars used in multiple rheumatic conditions offer the -potential for cost savings. We present the outcomes of a -service evaluation of switching rheumatic patients established on originator etanercept (Enbrel) to biosimilar Benepali, using a managed switching programme funded through a novel fixed price incentivisation model. Evaluation outcomes included savings in drug acquisition costs, patient-reported side effects, adverse events, patient outcomes and patient experience. A total of 154 patients on Enbrel were identified for switching. A total of 113 patients (43 had rheumatoid arthritis, 43 had axial spondyloarthritis and 27 had psoriatic arthritis) were switched from originator etanercept to Benepali from August 2016 to March 2017. The Royal Berkshire NHS Foundation Trust had the highest percentage of switches in the Thames Valley in this period. There was no increased incidence of side effects before and after switch. Drug acquisition costs were decreased by £95,000 with an overall reduction in prescribing costs of £186,000 for the local health economy. A managed switching programme from originator etanercept to biosimilar Benepali, using a novel fixed price model, delivers significant cost savings and investment in clinical services while maintaining similar patient-reported outcomes and good patient experience.

Effectiveness of etanercept biosimilar SB4 in maintaining low disease activity in patients with psoriatic arthritis switched from etanercept originator: an open-label one year study

Background: Currently, there are no studies specifically aimed at investigating the effectiveness of etanercept biosimilar SB4 in psoriatic arthritis (PsA).Objectives: Our primary objective was to verify the ability of SB4 to maintain low disease activity in patients switching from reference etanercept to SB4 after 1 year of treatment with this last drug.Methods: Eighty-seven PsA patients with low disease activity at baseline measured by using the clinical Disease Activity Index for Psoriatic Arthritis ≤ 13 (cDAPSA; range 0–154) were prospectively evaluated after 6 and 12 months when switching from the reference etanercept to SB4.Results: One year after switching from the reference etanercept to SB4, 76 (87.3%) out of 87 patients maintained a cDAPSA ≤ 13.Conclusions: SB4 was effective in maintaining a state of low disease activity in the majority of patients switched from the reference etanercept. However, the proportion of patients (11 subjects) who failed to maintain a state of low disease activity at the end of the study was statistically significant. Loss of effectiveness in the above subjects was mainly due to subjective evaluations given by the patients, rather than an objectifiable exacerbation of disease.

Different Policy Measures and Practices between Swedish Counties Influence Market Dynamics: Part 2-Biosimilar and Originator Etanercept in the Outpatient Setting.

BackgroundDiverging approaches towards market entry and uptake of biosimilars, even within a country, leads to regional variation in biosimilar use. This is the case in Sweden, where the 21 county councils control the healthcare budget and offer regional guidance.ObjectivesThis study aimed to analyse the market dynamics of originator and biosimilar etanercept (outpatient setting) in the different counties of Sweden, and examine the influence of local policy measures and practices, in addition to national policy.MethodsThis study was performed in three steps: (1) a structured review of the literature on (biosimilar) policies in Sweden; (2) analysis of market data on the counties’ originator and biosimilar etanercept uptake (quarter two 2012 to quarter four 2017) provided by IQVIA™; and (3) discussion of findings in face-to-face semi-structured interviews with the national pricing and reimbursement agency, key experts in the county councils of Skåne, Västra Götaland and Stockholm, and an industry representative.ResultsNotwithstanding the existence of a national managed entry agreement for etanercept, wide variations in biosimilar market shares between counties were observed (40–82% in 2017). Over time, early and late adopters of biosimilar etanercept can be distinguished. In quarter four 2017, biosimilar market shares of all counties slightly decreased in accordance with the lower priced originator product from 1 October 2017. As prescriptions for treatment with etanercept are often provided for a year, two approaches are possible to switch patients: active pullback of prescriptions resulting in additional workload, or wait until the patient’s next visit. Qualitative analysis indicated that the choice to use the biosimilar or the originator product depends on differences in rebated prices of the biosimilar and originator product, the presence of key opinion leaders, local guidelines, and financial streams and local gainsharing arrangements. Our estimates of current rebated prices and costs after gainsharing for the county councils and Government reveal only limited price differences between products.ConclusionsRegional variations in use of biosimilar etanercept can be seen although prices are coordinated nationally. This suggests that counties react differently to price differences and highlights the role of local policy and attitudes of stakeholders towards biosimilars and switching. It seems that some counties are hesitant to switch patients, as it is associated with an increased administrative workload that might not be compensated for by savings associated with a lower priced product.

O22 Frequency and reasons for switching back to etanercept originator following initial switch to etanercept biosimilar

O22 Frequency and reasons for switching back to etanercept originator following initial switch to etanercept biosimilar