Welcome to What’s it Worth - BONUS episode #2! Join your host Dr. Diana Langworthy and a come-back by P4 student co-host Marina Fahim as we get biosimilar! Our expert guest for this episode is Dr. Hannah Berg, Formulary Management Pharmacist at United Healthcare. We're discussing a trial that aimed to determine whether pegfilgrastim biosimilars were considered statistically equivalent to the pegfilgrastim originator product. Biosimilars have the potential to offer cost-savings for patients requiring these expensive agents as they can introduce market competition and a potentially cheaper alternative to originator products.
This bonus episode also coincides with a Journal Club assignment that students in my Evidence Based Practice course completed last week - Hello PHAR6782 Students! Great work on your first official Journal Clubs!
Key Points
- Biologic agents are key in managing or preventing certain disease states, however often they present cost challenges to patients and healthcare systems
- Febrile Neutropenia (FN) is a complication of high intensity chemotherapy regimens for patients with cancer
- The NCCN guidelines recommend that patients at high risk receive a granulocyte colony stimulating factor (G-CSF) such as pegfilgrastim for the prevention of FN
- Equivalence studies present an opportunity for pharmacists to critically evaluate historical data to determine clinical and statistical appropriateness of equivalence margins
- How can you best interpret equivalence margins? ---> Tune in to find out!
References
- [EPISODE TRIAL] Wang CY, Vouri SM, Park H, et al. Comparative effectiveness of pegfilgrastim biosimilars vs originator for prevention of febrile neutropenia: A retrospective cohort study. J Manag Care Spec Pharm. 2023;29(2):119-127.
- Griffiths EA, Roy V, Bachiashvili K, et al. Hematopoietic Growth Factors. NCCN Guidelines Version 1.2024. Accessed at https://www.nccn.org/professionals/physician_gls/pdf/growthfactors.pdf.
- Casazza G, Solbiati M. Can we trust equivalence and non-inferiority trials? Intern Emerg Med 2013;8:439-442.
- Biosimilar Regulatory Review and Approval. US Food and Drug Administration Guidance Document. Accessed at https://www.fda.gov/media/151061/download.
Contact Information
Podcast email: whatsitworthpodcast@gmail.com
Host Information
Dr. Diana R. Langworthy, PharmD, BCPS
Clinical Associate Professor, University of Minnesota College of Pharmacy
Clinical Pharmacist - Inpatient Internal Medicine, M Health Fairview East Bank Hospital
Co-Host: Marina Fahim, P4 PharmD Student 2024, University of Minnesota
Expert Guest Information
Dr. Hannah Berg, PharmD
Formulary Management Pharmacist
UnitedHealthcare