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Background There is over 10 years of clinical experience and evidence to show that biosimilar medicines can be used as safely and effectively in approved therapeutic indications as their originator biological medicines. In Ireland, biosimilar medicine uptake has been very slow, and savings to the health service will only be realised through fostering a competitive biological medicine market. Objective The objective of this study was to investigate the utilisation of biosimilars following a 'best-value biological' medicine initiative for adalimumab and etanercept in the Irish healthcare setting. Methods Data was extracted from the National High Tech claims database and High Tech ordering and management hub for the following drugs; adalimumab (Humira®, Amgevita®, Hulio®, Idacio®, and Imraldi®) and etanercept (Enbrel® and Benepali®). Main outcome measure: uptake of the best-value biological medicines. Results In June 2019, just over 90 patients had been initiated on, or switched to a best-value biological for adalimumab or etanercept. Over the next 12 months this increased to over 8500 patients. With the best-value biologicals accounting for approximately 50 % of market share in June 2020, the combined estimated savings and avoided costs are €22.7 million to date. The gain-share prescribing incentive has raised over €3.6 million for the specialties to invest back into patient care. Conclusion Against the background of a finite healthcare budget, this study shows that increasing use of biosimilars can create the financial savings and space to invest in new innovative therapies for the benefit of many patients., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG part of Springer Nature.)

Purpose: A rapidly increasing use of biological drugs has led to substantial costs. Shift to biosimilars enables considerable reduction of these costs without jeopardizing the treatment of patients, but most countries have extensive possibilities of untapped cost-savings. The aim of this study was to describe the Danish quick and near-complete implementation of the two first TNF inhibitor biosimilars (infliximab and etanercept)., Methods: We shed light on the considerations and experiences made during the implementation, and present key figures from the implementation., Results: The infliximab biosimilar constituted 90.6% of the total amount of infliximab four months following patent expiration of the biooriginator. Similar results were seen for etanercept biosimilar. Substantial cost reductions were experienced in the way that e.g. the infliximab-shift reduced cost by two thirds., Conclusion: We believe that a thorough preparation and an organizational setting supporting the implementation is crucial for the successful implementation. This same implementation model will be used for future biosimilars.

The aim of the study is to examine the frequency and costs associated with above-label dosing of biologics in patients with psoriatic arthritis (PsA). MarketScan identified adults with ≥1 International Classification of Diseases, Clinical Modification diagnosis for PsA and ≥1 pharmacy claim for biologics of interest between January 1, 2011 and December 31, 2013. The first biologic claim was the index date with a 1-year follow-up period and three additional months to confirm continuous biologic use. Exclusion criteria included switching to a different biologic or diagnosis with another autoimmune disease. During the follow-up period, duration was stratified into three groups: <30, 30-179, and ≥180 days of above-label dosing (>10% of the labeled dose). One-tailed t test was conducted to examine the impact of above-label duration on healthcare costs. We identified 4245 PsA patients receiving etanercept (n = 2342), adalimumab (n = 1788), and golimumab (n = 115). Above-label dosing of <30 days (85% adalimumab, 90.4% etanercept, and 95.7% golimumab) and ≥180 days (9.6% adalimumab, 4.1% etanercept, and 2.6% golimumab) was observed. All-cause total healthcare costs for <30 days of above-label use (etanercept $30,625, adalimumab $31,620, and golimumab $37,224), 30-179 days (etanercept $35,602, adalimumab $38,915, and golimumab $64,349), and ≥180 days (etanercept $55,349, adalimumab $54,176, and golimumab $47,993) were reported. Longer above-label duration (30-179 versus <30 days, ≥180 versus 30-179 and ≥180 days) with etanercept or adalimumab was significantly associated with higher mean increased total all-cause healthcare, PsA-specific healthcare, and biologic costs (p < 0.05). Above-label use of anti-TNF biologics does occur and is associated with significantly increased healthcare costs.

Background: Information on the use of ankylosing spondylitis (AS) therapies in clinical practice is a key factor in decision making, as more efficient treatments may involve substantial savings while maintaining the clinical benefits for the patient., Objective: To assess the mean annual doses and associated costs of the three main anti-tumour necrosis factor agents used in Spanish daily clinical practice in ankylosing spondylitis patients and to correlate these costs with disease activity., Setting: This retrospective, observational study included adult ankylosing spondylitis patients over a 4-year period that had been treated for at least 6 months with adalimumab, etanercept or infliximab at two University Hospitals in Spain., Methods: Disease activity was estimated with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores at the start of anti-tumour necrosis factor (anti-TNF) therapy and in the last visit or whenever the drug was switched. Mean costs were estimated for a 52-week horizon from the delivered doses registered by pharmacy records. Outcomes were the doses and costs of anti TNFs administered to each patient, and the BASDAI score., Results: A total of 119 patients (137 cases) were included (28 cases treated with adalimumab, 48 cases with etanercept and 61 with infliximab). Mean doses of adalimumab and etanercept were 92.8 and 88.8% of the initially prescribed doses, respectively, while the mean dose of infliximab administered was 102%. There were no statistical differences among treatments in terms of clinical effectiveness. Associated mean patient-year costs were significantly higher in the infliximab group (€14,235), compared to the other treatments [adalimumab €11,934; etanercept €10,516; (P < 0.05)]., Conclusion: In certain ankylosing spondylitis patients, doses and associated costs of biological therapies can be reduced while controlling disease activity. Mean doses used in our clinical practice vary from the recommended doses and are significantly lower for adalimumab and etanercept than for infliximab. These differences impact directly on associated patient-year costs, and, thus, on treatment efficiency.