Process and Clinical Outcomes of a Biosimilar Adoption Program with Infliximab-Dyyb

Bhat, Shubha; Altajar, Sarah; Shankar, Divya; Zahorian, Toni; Robert, Regine; Qazi, Taha; Shah, Bhavesh; Farraye, Francis A.

doi:10.18553/jmcp.2020.26.4.410

Cited by 15 publications

(9 citation statements)

References 23 publications

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“…If no other option exists, then such patients may need to be closely monitored and/or educated to maximize the likelihood of treatment persistence with the biosimilar. Indeed, mitigation measures, such as patient education, selection (e.g., based on disease stability and willingness to switch), and follow-up, have been associated with improved outcomes following switching for non-medical reasons [53,[64][65][66].…”

Section: Issues With Non-medical Switchingmentioning

confidence: 99%

The Automatic Substitution of Biosimilars: Definitions of Interchangeability are not Interchangeable

et al. 2021

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In the USA, an interchangeability designation provides biosimilar sponsors with a pathway for achieving what is standard for small-molecule generics: pharmacy-level auto-substitution for an innovator. No other major health authority links interchangeability to automatic substitution, as all require the involvement of the prescriber or patient in a medication change. This editorial considers the clinical impact and practicality of auto-substitution. First, interchangeability is linked to non-medical switching (NMS), the practice of switching treatment in patients with stable disease for non-clinical reasons. NMS may generate negative sentiment in those unwilling or reluctant to switch, which can adversely impact treatment outcomes (i.e., nocebo effect). Indeed, in real-world studies of tumor necrosis factor inhibitors, discontinuation rates have been shown to be higher in patients switched to biosimilars for non-medical reasons than in historical cohorts maintained on innovators. Second, interchangeability may impede pharmacovigilance and traceability, as not all jurisdictions require innovators and biosimilars to have distinct biologic names. Third, an interchangeability designation from the US Food and Drug Administration only permits a biosimilar to be automatically substituted for its innovator, not other biosimilars (if available). Pharmacist education would be needed to avoid off-label, automatic substitution among biosimilars of a single innovator. Last, once granted, an interchangeability designation exists in perpetuity under current US federal law. However, the supply chains of innovators and biosimilars are maintained independently, with no requirement for reconfirmation of biosimilarity or interchangeability. We feel that additional guidance is needed for the auto-substitution of biosimilars and innovators to become a reality.

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Section: Issues With Non-medical Switchingmentioning

confidence: 99%

The Automatic Substitution of Biosimilars: Definitions of Interchangeability are not Interchangeable

et al. 2021

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“…At our institution alone, there was an estimated cost savings of nearly $381,000 (ASP) and $651,000 (WAC) over the 20-month study period, consistent with prior research. 7,9,24,25 Utilization of biosimilars may be influenced by the type of institution, with a prior study showing slower use at an academic center compared to a Veterans Affairs medical center where savings per vial of biosimilar IFX was >$500. 26 As institutions and health insurance companies spend less money on biologic medications, through cost reduction because of marketplace competition, cost savings may eventually occur at the patient/family level.…”

Section: Discussionmentioning

confidence: 99%

“…Successful treatment with biosimilars has been described in both adults 7 and children with IBD in terms of efficacy, immunogenicity, safety/adverse events, [8][9][10] and clinical outcomes. [9][10][11] Position statements from multiple societal organizations support the utilization of biosimilars in the man-agement of IBD.…”

Section: Introductionmentioning

confidence: 99%

Increasing Biosimilar Utilization at a Pediatric Inflammatory Bowel Disease Center and Associated Cost Savings: Show Me the Money

Morris

McNicol

Boyle

et al. 2021

Inflammatory Bowel Diseases

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Background Tumor necrosis factor-alpha inhibitors (anti-TNFs) are a primary treatment for inflammatory bowel disease. Pharmaceutical expenditures and usage of specialty drugs are increasing. In the United States, biosimilars continue to be underutilized, despite opportunities for health care cost savings. Through quality improvement (QI) methodology, we aimed to increase biosimilar utilization among eligible patients initiating intravenous (IV) anti-TNF therapy and describe patient outcomes and associated cost savings. Methods Beginning in July 2019, all patients initiating IV anti-TNF therapy were identified and tracked. Using the Institute of Healthcare Improvement Plan-Do-Study-Act cycle, a four-stage problem-solving model used for carrying out change, we trialed interventions to increase biosimilar utilization, including provider, staff, and family education, and utilization of a clinical pharmacist and insurance specialist. Statistical process control charts were used to show improvement over time. Patients’ clinical outcome and cost savings were reviewed. Results Using QI methodology, we increased biosimilar utilization from a baseline of 1% in June 2019 to 96% by February 2021, with sustained improvement. The originator (infliximab) was the insurance company’s preferred product for 20 patients (20%). Patient outcomes (IV anti-TNF levels, absence of antidrug antibodies, and physician global assessment) between biosimilars and originators were similar. Estimated cost savings over the project duration were nearly $381,000 (average sales price) and $651,000 (wholesale acquisition cost). Conclusions Through QI methodology, we increased biosimilar utilization from 1% to 96% with sustained improvement, without compromising patient outcomes or safety. Estimated cost savings were substantial. Similar methodology could be implemented at other institutions to increase biosimilar utilization and potentially decrease health care costs.

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“…As previously described, patients on originator infliximab were switched to infliximab-dyyb as appropriate. 11 In 2020, another biosimilar, infliximab-abda, became the preferred infliximab product, and patients on originator infliximab and infliximab-dyyb switched to infliximab-abda as appropriate. Rapid infusion was maintained postswitch if patients were receiving this previously.…”

Section: Methodsmentioning

confidence: 99%

Safety of Rapid Infliximab Biosimilar Infusions in Patients With Inflammatory Bowel Disease

Kim

Bhat

2021

Ann Pharmacother

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Background The biosimilar landscape for inflammatory bowel disease (IBD) continues to grow, with several biosimilar products for originator infliximab now available. The rapid infusion of originator infliximab and infliximab-dyyb has been shown to be well tolerated; however, the tolerability of rapid infusion in patients receiving infliximab-abda, another infliximab biosimilar, or in those who have switched among originator infliximab and biosimilars remains unknown. Objective We aimed to evaluate the safety of rapid infusion in patients with IBD who received infliximab-abda or underwent switches with infliximab products. Methods We conducted a retrospective observational study of all infliximab-related infusion encounters for patients ≥18 years with IBD who received their infusion over 30 to 90 minutes at our institution between March 1, 2020, and September 30, 2020. Patient, disease, and treatment characteristics were collected. The primary outcome was infusion reactions. Results A total of 377 infusion encounters for 96 unique patients were evaluated. Within the study cohort, 16% of patients were treated with originator infliximab, 42% with infliximab-dyyb, and 2% with infliximab-abda. The remaining 41% of patients received at least 2 infliximab products during the study period, primarily infliximab-dyyb and infliximab-abda. Approximately 54% and 42% of infusions encounters included premedication and immunomodulator use. Within the 377 infusion encounters, no infusion reactions were noted. Conclusion and Relevance Rapid infusion of infliximab biosimilars (including infliximab-abda) and in patients who have switched among originator infliximab and biosimilars is well tolerated. Future studies should assess clinical impact and outcomes of rapid infusion with biosimilars.

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Process and Clinical Outcomes of a Biosimilar Adoption Program with Infliximab-Dyyb

Cited by 15 publications

References 23 publications

The Automatic Substitution of Biosimilars: Definitions of Interchangeability are not Interchangeable

The Automatic Substitution of Biosimilars: Definitions of Interchangeability are not Interchangeable

Increasing Biosimilar Utilization at a Pediatric Inflammatory Bowel Disease Center and Associated Cost Savings: Show Me the Money

Safety of Rapid Infliximab Biosimilar Infusions in Patients With Inflammatory Bowel Disease

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