Biologics have changed the landscape for the management of many debilitating chronic diseases but account for a significant expenditure of medications globally. Fortunately, advances in technology paved the way for the introduction of biosimilars, which are highly similar to the originator biologics. In the quest to reduce the budget impact of biologics, organizations have begun to adopt biosimilars. Institutions evaluating biosimilars for inclusion in the hospital formulary must make informed formulary decisions by conducting a thorough review of key elements for evaluation of biosimilars and address the multidimensional aspects during the selection process of different biosimilar products. Therefore, we aim to present an institutional guide of these elements to inform formulary decisions. These key elements include biosimilar evaluation for formulary addition; regulatory approval; substitution, interchangeability, and switching; extrapolation; product characteristics, manufacturing, and supply chain issues; pharmacoeconomic evaluations; traceability, nomenclature, and coding; education; and pharmacovigilance.
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http://dx.doi.org/10.1177/00185787221138007 | DOI Listing |
J Pharm Technol
December 2024
Department of Medicine, Larner College of Medicine, The University of Vermont, Burlington, VT, USA.
Infliximab is an anti-tumor necrosis factor agent used to treat rheumatologic disease. Evidence on the safety of switching to biosimilars and the associated risk factors for flares/loss of disease control within rheumatology is limited. The primary objective is to evaluate nonmedical switches from reference infliximab to biosimilars in rheumatology on risks and level of disease control.
View Article and Find Full Text PDFThe healthcare system in the United States (US) is complex and often fragmented across national and regional health plans which exhibit substantial variability in benefit design and formulary policies for accessing medications. We propose an access-focused value assessment framework for formulary decision-making for medications to manage immune-mediated inflammatory diseases (IMIDs), where patients are at the center of this framework. Formulary decision-making for IMID medications can be a challenging, even daunting, task with continuously evolving and enhanced treat-to-target goals.
View Article and Find Full Text PDFCan J Cardiol
January 2025
Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
Background: Canada is the only country with universal health care lacking universal pharmaceutical care (pharmacare). Currently, a minority portion of the population has drug coverage. Furthermore, there may be discordance between provincial plans of medications that are covered.
View Article and Find Full Text PDFJ Pharm Policy Pract
December 2024
Department of Pharmacy, School of Health Sciences, College of Medicine and Health, University of Birmingham, Birmingham, UK.
Background: Chronic kidney disease (CKD) is associated with comorbidities and altered pharmacokinetics, making appropriate prescribing, and monitoring necessary to minimise drug-related problems (DRPs). Therefore, this study aimed to describe the drug-utilisation pattern in hospitalised CKD patients.
Methods: An observational study was conducted in hospitalised adult (≥18 years old) CKD patients in the UK using WHO prescribing indicators, from November 2021 to April 2022 in a large teaching hospital in England from admission until discharge.
Int J Technol Assess Health Care
December 2024
Pharmaceutical Services Programme, Ministry of Health MalaysiaPetaling Jaya, Malaysia.
Objectives: Ministry of Health (MOH) Malaysia stakeholders seek primary care access to sodium-glucose cotransporter 2 inhibitor (SGLT2i). Addressing this required a complex decision, selecting among three SGLT2i for two different indications and two practice settings. The options include expanding the existing SGLT2i (empagliflozin) in the MOH Medicines Formulary to primary care and/or having dapagliflozin and/or luseogliflozin as alternatives.
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